| Product NDC: | 10631-117 |
| Proprietary Name: | Absorica |
| Non Proprietary Name: | isotretinoin |
| Active Ingredient(s): | 30 mg/1 & nbsp; isotretinoin |
| Administration Route(s): | ORAL |
| Dosage Form(s): | CAPSULE |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 10631-117 |
| Labeler Name: | Ranbaxy Laboratories Inc. |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | NDA021951 |
| Marketing Category: | NDA |
| Start Marketing Date: | 20120608 |
| Package NDC: | 10631-117-31 |
| Package Description: | 3 BLISTER PACK in 1 BOX (10631-117-31) > 10 CAPSULE in 1 BLISTER PACK (10631-117-69) |
| NDC Code | 10631-117-31 |
| Proprietary Name | Absorica |
| Package Description | 3 BLISTER PACK in 1 BOX (10631-117-31) > 10 CAPSULE in 1 BLISTER PACK (10631-117-69) |
| Product NDC | 10631-117 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | isotretinoin |
| Dosage Form Name | CAPSULE |
| Route Name | ORAL |
| Start Marketing Date | 20120608 |
| Marketing Category Name | NDA |
| Labeler Name | Ranbaxy Laboratories Inc. |
| Substance Name | ISOTRETINOIN |
| Strength Number | 30 |
| Strength Unit | mg/1 |
| Pharmaceutical Classes | Retinoid [EPC],Retinoids [Chemical/Ingredient] |