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NDC 10631-0002-31 Absorica LD 8 mg/1 Details
Absorica LD 8 mg/1
Absorica LD is a ORAL CAPSULE in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Sun Pharmaceutical Industries, Inc.. 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: 10631-0002-31Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Isotretinoin
Product Information
| NDC | 10631-0002 |
|---|---|
| Product ID | 10631-002_fba81535-0761-42a7-b422-338f8bd2cfc6 |
| Associated GPIs | 90050013100110 |
| GCN Sequence Number | 080449 |
| GCN Sequence Number Description | isotretinoin, micronized CAPSULE 8 MG ORAL |
| HIC3 | L1B |
| HIC3 Description | ACNE AGENTS,SYSTEMIC |
| GCN | 47294 |
| HICL Sequence Number | 046198 |
| HICL Sequence Number Description | ISOTRETINOIN, MICRONIZED |
| Brand/Generic | Brand |
| Proprietary Name | Absorica LD |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | isotretinoin |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | CAPSULE |
| Route | ORAL |
| Active Ingredient Strength | 8 |
| Active Ingredient Units | mg/1 |
| Substance Name | ISOTRETINOIN |
| Labeler Name | Sun Pharmaceutical Industries, Inc. |
| Pharmaceutical Class | Retinoid [EPC], Retinoids [CS] |
| DEA Schedule | n/a |
| Marketing Category | NDA |
| Application Number | NDA211913 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 10631-0002-31 (10631000231)
| NDC Package Code | 10631-002-31 |
|---|---|
| Billing NDC | 10631000231 |
| Package | 3 BLISTER PACK in 1 BOX (10631-002-31) / 10 CAPSULE in 1 BLISTER PACK |
| Marketing Start Date | 2019-11-20 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |