Cyproheptadine Hydrochloride
Apnar Pharma
Human Prescription Drug
NDC 24689-816Cyproheptadine Hydrochloride is a human prescription drug labeled by 'Apnar Pharma'. National Drug Code (NDC) number for Cyproheptadine Hydrochloride is 24689-816. This drug is available in dosage form of Tablet. The names of the active, medicinal ingredients in Cyproheptadine Hydrochloride drug includes Cyproheptadine Hydrochloride - 4 mg/1 . The currest status of Cyproheptadine Hydrochloride drug is Active.
Drug Information:
| Drug NDC: | 24689-816 |
| 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: | Cyproheptadine Hydrochloride |
| 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: | Cyproheptadine Hydrochloride |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Apnar Pharma |
| 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: | CYPROHEPTADINE HYDROCHLORIDE - 4 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: | 15 May, 2018 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 28 Feb, 2023 |
| 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: | ANDA207555 |
| 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: | 16 Jan, 2026 |
| 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: | Apnar Pharma
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 866144
|
| 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. |
| UPC: | 0324689816012
0324689816104
|
| UPC stands for Universal Product Code. |
| UNII: | NJ82J0F8QC
|
| 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. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 24689-816-01 | 100 TABLET in 1 BOTTLE (24689-816-01) | 21 May, 2018 | 28 Feb, 2023 | No |
| 24689-816-10 | 1000 TABLET in 1 BOTTLE (24689-816-10) | 21 May, 2018 | 28 Feb, 2023 | 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:
Cyproheptadine hydrochloride cyproheptadine hydrochloride lactose monohydrate magnesium stearate microcrystalline cellulose sodium starch glycolate type a potato cyproheptadine hydrochloride cyproheptadine it;68
Description:
Description cyproheptadine hcl usp is an antihistaminic and antiserotonergic agent. cyproheptadine hydrochloride usp is a white to slightly yellowish crystalline solid, with a molecular weight of 350.89, which is soluble in water, freely soluble in methanol, sparingly soluble in ethanol, soluble in chloroform, and practically insoluble in ether. it is the sesquihydrate of 4-(5h-dibenzo[a,d]cyclohepten-5-ylidene)-1-methylpiperidine hydrochloride. the molecular formula of the anhydrous salt is c 21 h 21 nâ¢hcl and the structural formula of the anhydrous salt is: c 21 h 21 n⢠hcl m.w. 350.89 cyproheptadine hydrochloride usp is available for oral administration in 4 mg tablets. inactive ingredients include: lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate. structure clinical pharmacology cyproheptadine is a serotonin and histamine antagonist with anticholinergic and sedative effects. antiserotonin and antihistamine drugs appear to compete with serotonin and histamine, respectively, for receptor sites. pharmacokinetics and metabolism after a single 4 mg oral dose of 14c-labelled cyproheptadine hcl in normal subjects, given as tablets, 2 to 20% of the radioactivity was excreted in the stools. only about 34% of the stool radioactivity was unchanged drug, corresponding to less than 5.7% of the dose. at least 40% of the administered radioactivity was excreted in the urine. no detectable amounts of unchanged drug were present in the urine of patients on chronic 12 to 20 mg daily doses. the principle metabolite found in human urine has been identified as a quaternary ammonium glucuronide conjugate of cyproheptadine. elimination is diminished in renal insufficiency.
Clinical Pharmacology:
Clinical pharmacology cyproheptadine is a serotonin and histamine antagonist with anticholinergic and sedative effects. antiserotonin and antihistamine drugs appear to compete with serotonin and histamine, respectively, for receptor sites. pharmacokinetics and metabolism after a single 4 mg oral dose of 14c-labelled cyproheptadine hcl in normal subjects, given as tablets, 2 to 20% of the radioactivity was excreted in the stools. only about 34% of the stool radioactivity was unchanged drug, corresponding to less than 5.7% of the dose. at least 40% of the administered radioactivity was excreted in the urine. no detectable amounts of unchanged drug were present in the urine of patients on chronic 12 to 20 mg daily doses. the principle metabolite found in human urine has been identified as a quaternary ammonium glucuronide conjugate of cyproheptadine. elimination is diminished in renal insufficiency.
Package Label Principal Display Panel:
Cyproheptadine hcl tablets usp 4mg 100-count 1000-count