Benzonatate

Proficient Rx Lp
Human Prescription Drug
NDC 71205-885

Benzonatate is a human prescription drug labeled by 'Proficient Rx Lp'. National Drug Code (NDC) number for Benzonatate is 71205-885. This drug is available in dosage form of Capsule. The names of the active, medicinal ingredients in Benzonatate drug includes Benzonatate - 100 mg/1 . The currest status of Benzonatate drug is Active.

Drug Information:

Drug NDC:	71205-885
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:	Benzonatate
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:	Benzonatate
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name:	Proficient Rx Lp
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form:	Capsule
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:	BENZONATATE - 100 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:	02 Aug, 2021
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date:	30 Dec, 2025
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:	ANDA091310
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:	Proficient Rx LP
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
RxCUI:	197397 283417
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.
UPC:	0371205886141 0371205885007
UPC stands for Universal Product Code.
NUI:	N0000009010 N0000175796
Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT).
UNII:	5P4DHS6ENR
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 EPC:	Non-narcotic Antitussive [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 PE:	Decreased Tracheobronchial Stretch Receptor Activity [PE]
Physiologic effect or pharmacodynamic effect—tissue, organ, or organ system level functional activity—of the drug’s established pharmacologic class. Takes the form of the effect, followed by `[PE]` (such as `Increased Diuresis [PE]` or `Decreased Cytokine Activity [PE]`.
Pharmacologic Class:	Decreased Tracheobronchial Stretch Receptor Activity [PE] Non-narcotic Antitussive [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
71205-885-00	100 CAPSULE in 1 BOTTLE (71205-885-00)	17 Sep, 2021	N/A	No
71205-885-10	10 CAPSULE in 1 BOTTLE (71205-885-10)	17 Sep, 2021	N/A	No
71205-885-14	14 CAPSULE in 1 BOTTLE (71205-885-14)	17 Sep, 2021	N/A	No
71205-885-15	15 CAPSULE in 1 BOTTLE (71205-885-15)	17 Sep, 2021	N/A	No
71205-885-20	20 CAPSULE in 1 BOTTLE (71205-885-20)	17 Sep, 2021	N/A	No
71205-885-21	21 CAPSULE in 1 BOTTLE (71205-885-21)	17 Sep, 2021	N/A	No
71205-885-30	30 CAPSULE in 1 BOTTLE (71205-885-30)	17 Sep, 2021	N/A	No
71205-885-55	500 CAPSULE in 1 BOTTLE (71205-885-55)	17 Sep, 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:

Benzonatate benzonatate benzonatate benzonatate gelatin, unspecified glycerin methylparaben propylparaben d&c yellow no. 10 shellac titanium dioxide isopropyl alcohol butyl alcohol propylene glycol ammonia dimethicone silicon dioxide clear; yellow a benzonatate benzonatate benzonatate benzonatate gelatin, unspecified glycerin methylparaben propylparaben d&c yellow no. 10 shellac titanium dioxide isopropyl alcohol butyl alcohol propylene glycol ammonia dimethicone silicon dioxide clear; yellow a2

Indications and Usage:

Indications and usage benzonatate capsules usp are indicated for the symptomatic relief of cough.

Warnings:

Warnings severe hypersensitivity reactions (including bronchospasm, laryngospasm and cardiovascular collapse) have been reported which are possibly related to local anesthesia from sucking or chewing the capsule instead of swallowing it. severe reactions have required intervention with vasopressor agents and supportive measures. isolated instances of bizarre behavior, including mental confusion and visual hallucinations, have also been reported in patients taking benzonatate capsules usp in combination with other prescribed drugs.

Dosage and Administration:

Dosage and administration adults and children over 10: usual dose is one 100 mg or 200 mg capsule t.i.d. as required. if necessary, up to 600 mg daily may be given.

Contraindications:

Contraindications hypersensitivity to benzonatate or related compounds.

Adverse Reactions:

Adverse reactions potential adverse reactions to benzonatate capsules usp may include: hypersensitivity reactions including bronchospasm, laryngospasm, and cardiovascular collapse possibly related to local anesthesia from chewing or sucking the capsule. cns: sedation; headache; dizziness; mental confusion; visual hallucinations. gi: constipation; nausea; gi upset. dermatologic: pruritus; skin eruptions. other: nasal congestion; sensation of burning in the eyes; vague "chilly" sensation; numbness of the chest; hypersensitivity. rare instances of deliberate or accidental overdose have resulted in death.

Overdosage:

Overdosage overdose may result in death. the drug is chemically related to tetracaine and other topical anesthetics and shares various aspects of their pharmacology and toxicology. drugs of this type are generally well absorbed after ingestion. signs and symptoms: if capsules are chewed or dissolved in the mouth, oropharyngeal anesthesia will develop rapidly. cns stimulation may cause restlessness and tremors which may proceed to clonic convulsions followed by profound cns depression. treatment: evacuate gastric contents and administer copious amounts of activated charcoal slurry. even in the conscious patient, cough and gag reflexes may be so depressed as to necessitate special attention to protection against aspiration of gastric contents and orally administered materials. convulsions should be treated with a short-acting barbiturate given intravenously and carefully titrated for the smallest effective dosage. intensive support of respiration and cardiovascular-renal function is an essential feature of the treatment of severe intoxication from overdosage. do not use cns stimulants.

Description:

Description benzonatate, a non-narcotic oral antitussive agent, is 2, 5, 8, 11, 14, 17, 20, 23, 26-nonaoxaoctacosan- 28-yl p-(butylamino) benzoate; with a molecular weight of 603.0. each benzonatate capsule usp, 100 mg contains: benzonatate, usp 100 mg. each benzonatate capsule usp, 200 mg contains: benzonatate, usp 200 mg. benzonatate capsules usp also contain: gelatin 175 bloom bone nf, glycerin 99% usp, methyl/propyl paraben blend (4:1 ), yellow #10-dc and white ink (shellac glaze in sd-45, titanium dioxide, isopropyl alcohol, n-butyl alcohol, propylene glycol, ammonium hydroxide and simethicone). shape description automatically generated

Clinical Pharmacology:

Clinical pharmacology benzonatate acts peripherally by anesthetizing the stretch receptors located in the respiratory passages, lungs, and pleura by dampening their activity and thereby reducing the cough reflex at its source. it begins to act within 15 to 20 minutes and its effect lasts for 3 to 8 hours. benzonatate has no inhibitory effect on the respiratory center in recommended dosage.

How Supplied:

How supplied benzonatate capsules usp 100 mg are available for oral administration as a clear, colorless to pale yellow oil in a clear, yellow softgel shell imprinted "a" in white ink. they are supplied as follows: bottles of 10 (ndc 71205-885-10) bottles of 14 (ndc 71205-885-14) bottles of 15 (ndc 71205-885-15) bottles of 20 (ndc 71205-885-20) bottles of 21 (ndc 71205-885-21) bottles of 30 (ndc 71205-885-30) bottles of 100 (ndc 71205-885-00) bottles of 500 (ndc 71205-885-55) benzonatate capsules usp 200 mg are available for oral administration as a clear, colorless to pale yellow oil in a clear, yellow softgel shell imprinted "a2" in white ink. they are supplied as follows: bottles of 10 (ndc 71205-886-10) bottles of 14 (ndc 71205-886-14) bottles of 15 (ndc 71205-886-15) bottles of 20 (ndc 71205-886-20) bottles of 21 (ndc 71205-886-21) bottles of 30 (ndc 71205-886-30) bottles of 100 (ndc 71205-886-00) bottles of 500 (ndc 71205-886-55) storage store at 20Â° to 25Â°c (68Â° to 77Â Read more...

° f); excursions permitted to 15Â° to 30Â°c (59Â° to 86Â°f) [see usp controlled room temperature]. dispense in a tight, light-resistant container [see usp]. protect from moisture. manufactured by: catalent pharma solutions windsor, on canada n9c 3r5 manufactured for: acella pharmaceuticals, llc alpharetta, ga 30005 repackaged and relabeled by: proficient rx lp thousand oaks, ca 91320 l-0273 rev 1020-01

Package Label Principal Display Panel:

Package label.principal display panel 71205-885-00 71205-886-14

Comments/ Reviews:

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