Benzonatate
Camber Pharmaceuticals, Inc.
Human Prescription Drug
NDC 31722-956Benzonatate is a human prescription drug labeled by 'Camber Pharmaceuticals, Inc.'. National Drug Code (NDC) number for Benzonatate is 31722-956. 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: | 31722-956 |
| 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: | Camber Pharmaceuticals, Inc. |
| 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: | 22 Feb, 2019 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 20 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: | ANDA211518 |
| 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: | Camber Pharmaceuticals, Inc.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 197397
283417
903291
|
| 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: | 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 |
|---|
| 31722-956-01 | 100 CAPSULE in 1 BOTTLE (31722-956-01) | 22 Feb, 2019 | N/A | No |
| 31722-956-05 | 500 CAPSULE in 1 BOTTLE (31722-956-05) | 22 Feb, 2019 | N/A | No |
| 31722-956-30 | 30 CAPSULE in 1 BOTTLE (31722-956-30) | 22 Feb, 2019 | 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. |
Product Elements:
Benzonatate benzonatate benzonatate benzonatate gelatin water glycerin medium-chain triglycerides lecithin, soybean isopropyl alcohol nitrogen d&c yellow no. 10 ferrosoferric oxide propylene glycol hypromelloses 1 benzonatate benzonatate benzonatate benzonatate gelatin water glycerin medium-chain triglycerides lecithin, soybean isopropyl alcohol nitrogen fd&c yellow no. 6 ferrosoferric oxide propylene glycol hypromelloses 2 benzonatate benzonatate benzonatate benzonatate gelatin water glycerin medium-chain triglycerides lecithin, soybean isopropyl alcohol nitrogen d&c yellow no. 10 ferrosoferric oxide propylene glycol hypromelloses 3
Indications and Usage:
Indications and usage benzonatate capsules is indicated for the symptomatic relief of cough.
Warnings:
Warnings hypersensitivity 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. psychiatric effects isolated instances of bizarre behavior, including mental confusion and visual hallucinations, have also been reported in patients taking benzonatate capsules in combination with other prescribed drugs. accidental ingestion and death in children keep benzonatate capsules out of reach of children. accidental ingestion of benzonatate capsules resulting in death has been reported in children below age 10. signs and symptoms of overdose have been reported within 15-20 minutes and death has been reported within one hour of ingestion. if accidental ingestion occurs, seek medical attention immediately (see overdosage).
Dosage and Administration:
Dosage and administration adults and children over 10 years of age: usual dose is one 100 mg, 150 mg or 200 mg capsule three times a day as needed for cough. if necessary to control cough, up to 600 mg daily in three divided doses may be given. b enzonatate capsules should be swallowed whole. benzonatate capsules are not to be broken, chewed, dissolved, cut or crushed.
Contraindications:
Contraindications hypersensitivity to benzonatate or related compounds.
Adverse Reactions:
Adverse reactions potential adverse reactions to benzonatate capsules may include: hypersensitivity reactions including bronchospasm, laryngospasm, 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. der m atologic: pruritus; skin eruptions. other: nasal congestion; sensation of burning in the eyes; vague âchillyâ sensation; numbness of the chest; hypersensitivity. deliberate or accidental overdose has resulted in death, particularly in children.
Overdosage:
Overdosage intentional and unintentional overdose may result in death, particularly in children. 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 the signs and symptoms of overdose of benzonatate have been reported within 15-20 minutes. if capsules are chewed or dissolved in the mouth, oropharyngeal anesthesia will develop rapidly, which may cause choking and airway compromise. cns stimulation may cause restlessness and tremors which may proceed to clonic convulsions followed by profound cns depression. convulsions, coma, cerebral edema and cardiac arrest leading to death have been reported within 1 hour of ingestion. treatment: in case of overdose, seek medical attention immediately. 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 603.7. each benzonatate capsule usp contains: benzonatate, usp 100 mg each benzonatate capsule usp contains: benzonatate, usp 150 mg each benzonatate capsule usp contains: benzonatate, usp 200 mg benzonatate capsules usp also contain: bloom gelatin, glycerin, purified water, medium chain triglycerides, lecithin, isopropyl alcohol, nitrogen. 100 mg and 200 mg capsules also contain d&c yellow no. 10. 150 mg capsules also contain fd&c yellow no. 6 powder. each capsule also contains black iron oxide, propylene glycol, hypromellose as imprinting ink. benzonatate-struct
Clinical Pharmacology:
Clinical pharmacology benzonatate capsules 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 capsules has no inhibitory effect on the respiratory center in recommended dosage.
How Supplied:
How supplied benzonatate capsules, usp are available in 100 mg, 150 mg and 200 mg dosage strengths. the 100 mg capsules are yellow round capsules containing clear to light yellow liquid, printed with â1â sign in black ink. ndc 31722-956-30 bottles of 30 capsules ndc 31722-956-01 bottles of 100 capsules ndc 31722-956-05 bottles of 500 capsules the 150 mg capsules are orange round capsules containing clear, light yellow to orange liquid, printed with â2â sign in black ink. ndc 31722-957-30 bottles of 30 capsules ndc 31722-957-01 bottles of 100 capsules ndc 31722-957-05 bottles of 500 capsules the 200 mg capsules are yellow round capsules containing clear to light yellow liquid, printed with â3â sign in black ink. ndc 31722-958-30 bottles of 30 capsules ndc 31722-958-01 bottles of 100 capsules ndc 31722-958-05 bottles of 500 capsules store at 20°c to 25°c (68°f to77°f) [see usp controlled room temperature]. protect from light. dispense in tight, l
Read more...ight-resistant container as defined in the usp with a child-resistant closure. manufactured by: ascent pharmaceuticals, inc. central islip, ny 11722 manufactured for: camber pharmaceuticals, inc. piscataway, nj 08854 rev: 07/21
Package Label Principal Display Panel:
Benzonatate capsules 100 mg-500 ct ndc:31722-956-05 benzonatate capsules 150 mg-500 ct ndc:31722-957-05 benzonatate capsules 200 mg-500 ct ndc:31722-958-05 benzonatate-100mg benzonatate-150mg benzonatate-200mg