Baclofen

Aurobindo Pharma Limited
Human Prescription Drug
NDC 59651-394

Baclofen is a drug for further processing labeled by 'Aurobindo Pharma Limited'. National Drug Code (NDC) number for Baclofen is 59651-394. This drug is available in dosage form of Tablet. The names of the active, medicinal ingredients in Baclofen drug includes Baclofen - 10 mg/1 . The currest status of Baclofen drug is Active.

Drug Information:

Drug NDC:	59651-394
The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
Proprietary Name:	Baclofen
Also known as the trade name. It is the name of the product chosen by the labeler.
Product Type:	Human Prescription Drug
Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing.
Non Proprietary Name:	Baclofen
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name:	Aurobindo Pharma Limited
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form:	Tablet
The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources.
Status:	Active
FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved.
Substance Name:	BACLOFEN - 10 mg/1
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
Route Details:	ORAL
The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Marketing Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.

Marketing Category:	ANDA
Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (ANDA), BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
Marketing Start Date:	13 Jul, 2021
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date:	24 Dec, 2024
This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
Application Number:	ANDA214099
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
Listing Expiration Date:	31 Dec, 2023
This is the date when the listing record will expire if not updated or certified by the firm.

OpenFDA Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.

Manufacturer Name:	Aurobindo Pharma Limited
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
RxCUI:	197391 197392
The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms.
Original Packager:	Yes
Whether or not the drug has been repackaged for distribution.
NUI:	N0000000196 N0000000116 N0000175759
Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT).
UNII:	H789N3FKE8
Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information.
Pharmacologic Class MOA:	GABA A Agonists [MoA] GABA B Agonists [MoA]
Mechanism of action of the drug—molecular, subcellular, or cellular functional activity—of the drug’s established pharmacologic class. Takes the form of the mechanism of action, followed by `[MoA]` (such as `Calcium Channel Antagonists [MoA]` or `Tumor Necrosis Factor Receptor Blocking Activity [MoA]`.
Pharmacologic Class EPC:	gamma-Aminobutyric Acid-ergic Agonist [EPC]
Established pharmacologic class associated with an approved indication of an active moiety (generic drug) that the FDA has determined to be scientifically valid and clinically meaningful. Takes the form of the pharmacologic class, followed by `[EPC]` (such as `Thiazide Diuretic [EPC]` or `Tumor Necrosis Factor Blocker [EPC]`.
Pharmacologic Class:	GABA A Agonists [MoA] GABA B Agonists [MoA] gamma-Aminobutyric Acid-ergic Agonist [EPC]
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

Packaging Information:

Package NDC	Description	Marketing Start Date	Marketing End Date	Sample Available
59651-394-01	100 TABLET in 1 BOTTLE (59651-394-01)	13 Jul, 2021	N/A	No
59651-394-05	500 TABLET in 1 BOTTLE (59651-394-05)	13 Jul, 2021	N/A	No
59651-394-99	1000 TABLET in 1 BOTTLE (59651-394-99)	13 Jul, 2021	N/A	No
Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together.

Other medicines with the same generic name

Product Elements:

Baclofen baclofen baclofen baclofen silicon dioxide magnesium stearate microcrystalline cellulose 112 starch, corn white to off white b;10 baclofen baclofen baclofen baclofen silicon dioxide magnesium stearate microcrystalline cellulose 112 starch, corn white to off white b;20

Indications and Usage:

Indications and usage baclofen tablets are useful for the alleviation of signs and symptoms of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity. patients should have reversible spasticity so that baclofen tablets treatment will aid in restoring residual function. baclofen tablets may also be of some value in patients with spinal cord injuries and other spinal cord diseases. baclofen tablets are not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders. the efficacy of baclofen in stroke, cerebral palsy, and parkinsons disease has not been established and, therefore, it is not recommended for these conditions.

Warnings:

Warnings a. neonatal withdrawal symptoms: withdrawal symptoms have been reported starting hours to days after delivery in neonates whose mothers were treated with oral baclofen throughout pregnancy. the symptoms of withdrawal in these infants have included increased muscle tone, tremor, jitteriness, and seizure. if the potential benefit justifies the potential risk to the fetus and oral baclofen is continued during pregnancy, gradually reduce the dose and discontinue baclofen before delivery. if slow withdrawal is not feasible, advise the parents or caregivers of the potential for neonatal withdrawal. b. abrupt drug withdrawal: hallucinations and seizures have occurred on abrupt withdrawal of baclofen. therefore, except for serious adverse reactions, the dose should be reduced slowly when the drug is discontinued. c. impaired renal function: because baclofen is primarily excreted unchanged through the kidneys, it should be given with caution, and it may be necessary to reduce the dosag Read more...

e. d. stroke: baclofen has not significantly benefited patients with stroke. these patients have also shown poor tolerability to the drug. e. pregnancy: baclofen has been shown to increase the incidence of omphaloceles (ventral hernias) in fetuses of rats given approximately 13 times the maximum dose recommended for human use, at a dose which caused significant reductions in food intake and weight gain in dams. this abnormality was not seen in mice or rabbits. there was also an increased incidence of incomplete sternebral ossification in fetuses of rats given approximately 13 times the maximum recommended human dose, and an increased incidence of unossified phalangeal nuclei of forelimbs and hindlimbs in fetuses of rabbits given approximately 7 times the maximum recommended human dose. in mice, no teratogenic effects were observed, although reductions in mean fetal weight with consequent delays in skeletal ossification were present when dams were given 17 and 34 times the human daily dose. there are no studies in pregnant women. baclofen should be used during pregnancy only if the benefit clearly justifies the potential risk to the fetus.

Dosage and Administration:

Dosage and administration the determination of optimal dosage requires individual titration. start therapy at a low dosage and increase gradually until optimum effect is achieved (usually between 40 to 80 mg daily). the following dosage titration schedule is suggested: 5 mg t.i.d. for 3 days 10 mg t.i.d. for 3 days 15 mg t.i.d. for 3 days 20 mg t.i.d. for 3 days thereafter additional increases may be necessary but the total daily dose should not exceed a maximum of 80 mg daily (20 mg q.i.d.). the lowest dose compatible with an optimal response is recommended. if benefits are not evident after a reasonable trial period, patients should be slowly withdrawn from the drug (see warnings abrupt drug withdrawal ).

Contraindications:

Contraindications hypersensitivity to baclofen.

Adverse Reactions:

Adverse reactions the most common is transient drowsiness (10% to 63%). in one controlled study of 175 patients, transient drowsiness was observed in 63% of those receiving baclofen compared to 36% of those in the placebo group. other common adverse reactions are dizziness (5% to 15%), weakness (5% to 15%) and fatigue (2% to 4%). others reported: neuropsychiatric: confusion (1% to 11%), headache (4% to 8%), insomnia (2% to 7%); and, rarely, euphoria, excitement, depression, hallucinations, paresthesia, muscle pain, tinnitus, slurred speech, coordination disorder, tremor, rigidity, dystonia, ataxia, blurred vision, nystagmus, strabismus, miosis, mydriasis, diplopia, dysarthria, epileptic seizure. cardiovascular: hypotension (0% to 9%). rare instances of dyspnea, palpitation, chest pain, syncope. gastrointestinal: nausea (4% to 12%), constipation (2% to 6%); and, rarely, dry mouth, anorexia, taste disorder, abdominal pain, vomiting, diarrhea, and positive test for occult blood in stool. Read more...

genitourinary: urinary frequency (2% to 6%); and, rarely, enuresis, urinary retention, dysuria, impotence, inability to ejaculate, nocturia, hematuria. other: instances of rash, pruritus, ankle edema, excessive perspiration, weight gain, nasal congestion. some of the cns and genitourinary symptoms may be related to the underlying disease rather than to drug therapy. the following laboratory tests have been found to be abnormal in a few patients receiving baclofen: increased sgot, elevated alkaline phosphatase, and elevation of blood sugar.

Pediatric Use:

Pediatric use safety and effectiveness in pediatric patients below the age of 12 years have not been established.

Overdosage:

Overdosage signs and symptoms: vomiting, muscular hypotonia, drowsiness, accommodation disorders, coma, respiratory depression, and seizures. treatment: in the alert patient, empty the stomach promptly by induced emesis followed by lavage. in the obtunded patient, secure the airway with a cuffed endotracheal tube before beginning lavage (do not induce emesis). maintain adequate respiratory exchange, do not use respiratory stimulants.

Description:

Description baclofen usp, is a muscle relaxant and antispastic, available as 10 mg and 20 mg tablets for oral administration. its chemical name is 4-amino-3-(4-chlorophenyl)- butanoic acid, and its structural formula is baclofen usp is a white to off-white crystalline powder, with a molecular weight of 213.66. it is slightly soluble in water, very slightly soluble in methanol and in 96% ethanol, practically insoluble in acetone, insoluble in chloroform, dissolves in dilute mineral acids and in dilute solutions of alkali hydroxides. inactive ingredients. colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose and pregelatinized starch (maize). fda approved dissolution test specifications differ from usp. chemical structure

Clinical Pharmacology:

Clinical pharmacology the precise mechanism of action of baclofen is not fully known. baclofen is capable of inhibiting both monosynaptic and polysynaptic reflexes at the spinal level, possibly by hyperpolarization of afferent terminals, although actions at supraspinal sites may also occur and contribute to its clinical effect. although baclofen is an analog of the putative inhibitory neurotransmitter gamma-aminobutyric acid (gaba), there is no conclusive evidence that actions on gaba systems are involved in the production of its clinical effects. in studies with animals, baclofen has been shown to have general cns depressant properties as indicated by the production of sedation with tolerance, somnolence, ataxia, and respiratory and cardiovascular depression. baclofen is rapidly and extensively absorbed and eliminated. absorption may be dose-dependent, being reduced with increasing doses. baclofen is excreted primarily by the kidney in unchanged form and there is relatively large inte Read more...

rsubject variation in absorption and/or elimination.

How Supplied:

How supplied baclofen tablets usp, 10 mg are white to off-white, round, flat-faced, beveled-edge scored tablet debossed with b above score line and 10 below score line on one side and plain on other side. they are supplied as follows: bottles of 100 ndc 59651-394-01 bottles of 500 ndc 59651-394-05 bottles of 1,000 ndc 59651-394-99 baclofen tablets usp, 20 mg are white to off-white, round, flat-faced, beveled-edge scored tablet debossed with b above score line and 20 below score line on one side and plain on other side. they are supplied as follows: bottles of 100 ndc 59651-395-01 bottles of 500 ndc 59651-395-05 bottles of 1,000 ndc 59651-395-99 store at 20° to 25°c (68° to 77°f) [see usp controlled room temperature]. dispense in a well-closed container as defined in the usp, with a child-resistant closure (as required). distributed by: aurobindo pharma usa, inc. 279 princeton-hightstown road east windsor, nj 08520 manufactured by: aurobindo pharma limited hyderabad� Read more...

�500 032, india revised: 10/2021

Package Label Principal Display Panel:

Package label-principal display panel - 10 mg (100 tablet bottle) ndc 59651-394-01 rx only baclofen tablets, usp 10 mg aurobindo 100 tablets package label-principal display panel - 10 mg (100 tablet bottle)

Package label-principal display panel - 20 mg (100 tablet bottle) ndc 59651-395-01 rx only baclofen tablets, usp 20 mg aurobindo 100 tablets package label-principal display panel - 20 mg (100 tablet bottle)

Comments/ Reviews:

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