Adapalene
Glenmark Pharmaceuticals Inc., Usa
Human Otc Drug
NDC 72657-102Adapalene is a human otc drug labeled by 'Glenmark Pharmaceuticals Inc., Usa'. National Drug Code (NDC) number for Adapalene is 72657-102. This drug is available in dosage form of Gel. The names of the active, medicinal ingredients in Adapalene drug includes Adapalene - 1 mg/g . The currest status of Adapalene drug is Active.
Drug Information:
| Drug NDC: | 72657-102 |
| 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: | Adapalene |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Product Type: | Human Otc 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: | Adapalene |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Glenmark Pharmaceuticals Inc., Usa |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Gel |
| 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: | ADAPALENE - 1 mg/g
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | TOPICAL
|
| 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: | 01 Jan, 2023 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 23 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: | ANDA091314 |
| 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, 2024 |
| 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: | Glenmark Pharmaceuticals Inc., USA
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 307731
|
| 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: | N0000175607
M0018962
|
| Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT). |
| UNII: | 1L4806J2QF
|
| 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: | Retinoid [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 CS: | Retinoids [CS]
|
| Chemical structure classification of the drug product’s pharmacologic class. Takes the form of the classification, followed by `[Chemical/Ingredient]` (such as `Thiazides [Chemical/Ingredient]` or `Antibodies, Monoclonal [Chemical/Ingredient]. |
| Pharmacologic Class: | Retinoid [EPC]
Retinoids [CS]
|
| 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 |
|---|
| 72657-102-17 | 1 TUBE in 1 CARTON (72657-102-17) / 15 g in 1 TUBE | 01 Jan, 2023 | N/A | No |
| 72657-102-55 | 1 TUBE in 1 CARTON (72657-102-55) / 45 g in 1 TUBE | 01 Jan, 2023 | 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. |
Purpose:
Purpose acne treatment
Product Elements:
Adapalene adapalene adapalene adapalene carbomer homopolymer type c (allyl pentaerythritol crosslinked) edetate disodium poloxamer 182 propylene glycol water sodium hydroxide methylparaben
Indications and Usage:
Use ⪠for the treatment of acne
Warnings:
Warnings for external use only do not use ⢠on damaged skin (cuts, abrasions, eczema, sunburn) ⢠if you are allergic to adapalene or any of the ingredients in this product if pregnant or breastfeeding , ask a doctor before use when using this product ⢠limit sun exposure, including light from tanning beds, and use sunscreen when going outdoors ⢠do not wax to remove hair in areas where the product has been applied ⢠during the early weeks of use, your acne may appear to worsen before it improves (this is normal); continue using as directed, unless you get irritation that becomes severe ⢠irritation (redness, itching, dryness, burning) is more likely to occur: ⢠in the first few weeks of use ⢠if using more than one topical acne medication at a time ⢠but irritation usually lessens with continued use of this product ⢠it may take up to 3 months of once daily use to see results ⢠avoid product contact with eyes, lips, and mouth. if c
Read more...ontact occurs, immediately flush the area with water. ⢠wash hands after use stop use and ask doctor if ⢠you become pregnant, or are planning to become pregnant, while using the product ⢠you have symptoms of an allergic reaction (such as itching, rash, hives, swelling of the lips, eyelids, and shortness of breath) ⢠irritation becomes severe ⢠you see no improvement after 3 months of once daily use
Dosage and Administration:
Directions ⢠adults and children 12 years of age and older: ⢠use once daily ⢠clean the skin gently and pat dry before applying the product ⢠cover the entire affected area with a thin layer. for example, if your acne is on the face, apply the product to the entire face. ⢠do not use more than one time a day. applying more than directed will not provide faster or better results, but may worsen skin irritation. ⢠children under 12 years of age : ask a doctor
Package Label Principal Display Panel:
Package/label principal display panel ndc 72657-102-17 adapalene gel usp, 0.1% net wt. 0.5 oz (15 g) carton15mg
Package/label principal display panel ndc 72657-102-55 adapalene gel usp, 0.1% net wt. 1.6 oz (45 g) carton45gm