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NDC 21922-0043-40 Tretinoin 0.8 mg/g Details
Tretinoin 0.8 mg/g
Tretinoin is a TOPICAL GEL in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Encube Ethicals Private Limited. The primary component is TRETINOIN.
MedlinePlus Drug Summary
Tretinoin (Altreno, Atralin, Avita, Retin-A) is used to treat acne. Tretinoin is also used to reduce fine wrinkles (Refissa and Renova) and to improve spotty discoloration (Renova) and rough feeling skin (Renova) when used along with other skin care and sunlight avoidance programs. Tretinoin is in a class of medications called retinoids. It works by promoting peeling of affected skin areas and unclogging pores.
Related Packages: 21922-0043-40Last Updated: 03/24/2024
MedLinePlus Full Drug Details: Tretinoin Topical
Product Information
| NDC | 21922-0043 |
|---|---|
| Product ID | 21922-043_95dc7c2e-92ec-4c5c-924c-832642461c51 |
| Associated GPIs | |
| GCN Sequence Number | 072395 |
| GCN Sequence Number Description | tretinoin microspheres GEL W/PUMP 0.08 % TOPICAL |
| HIC3 | L9B |
| HIC3 Description | VITAMIN A DERIVATIVES |
| GCN | 36604 |
| HICL Sequence Number | 032888 |
| HICL Sequence Number Description | TRETINOIN MICROSPHERES |
| Brand/Generic | Generic |
| Proprietary Name | Tretinoin |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Tretinoin |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | GEL |
| Route | TOPICAL |
| Active Ingredient Strength | 0.8 |
| Active Ingredient Units | mg/g |
| Substance Name | TRETINOIN |
| Labeler Name | Encube Ethicals Private Limited |
| Pharmaceutical Class | Retinoid [EPC], Retinoids [CS] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA215609 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 21922-0043-40 (21922004340)
| NDC Package Code | 21922-043-40 |
|---|---|
| Billing NDC | 21922004340 |
| Package | 1 BOTTLE, PUMP in 1 CARTON (21922-043-40) / 50 g in 1 BOTTLE, PUMP |
| Marketing Start Date | 2023-08-24 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |