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NDC 68308-0782-30 Isotretinoin 20 mg/1 Details
Isotretinoin 20 mg/1
Isotretinoin is a ORAL CAPSULE, LIQUID FILLED in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Mayne Pharma. The primary component is ISOTRETINOIN.
MedlinePlus Drug Summary
Isotretinoin is used to treat severe recalcitrant nodular acne (a certain type of severe acne) that has not been helped by other treatments, such as antibiotics. Isotretinoin is in a class of medications called retinoids. It works by slowing the production of certain natural substances that can cause acne.
Related Packages: 68308-0782-30Last Updated: 04/28/2024
MedLinePlus Full Drug Details: Isotretinoin
Product Information
| NDC | 68308-0782 |
|---|---|
| Product ID | 68308-782_ff060e85-efb7-4b9f-a624-2a63effa65fe |
| Associated GPIs | |
| GCN Sequence Number | 036046 |
| GCN Sequence Number Description | isotretinoin CAPSULE 20 MG ORAL |
| HIC3 | L1B |
| HIC3 Description | ACNE AGENTS,SYSTEMIC |
| GCN | 59842 |
| HICL Sequence Number | 002476 |
| HICL Sequence Number Description | ISOTRETINOIN |
| Brand/Generic | Generic |
| Proprietary Name | Isotretinoin |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Isotretinoin |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | CAPSULE, LIQUID FILLED |
| Route | ORAL |
| Active Ingredient Strength | 20 |
| Active Ingredient Units | mg/1 |
| Substance Name | ISOTRETINOIN |
| Labeler Name | Mayne Pharma |
| Pharmaceutical Class | Retinoid [EPC], Retinoids [CS] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA076485 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 68308-0782-30 (68308078230)
| NDC Package Code | 68308-782-30 |
|---|---|
| Billing NDC | 68308078230 |
| Package | 3 BLISTER PACK in 1 BOX (68308-782-30) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (68308-782-01) |
| Marketing Start Date | 2023-12-01 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |