| Product NDC: | 0555-1055 | 
| Proprietary Name: | Claravis | 
| Non Proprietary Name: | isotretinoin | 
| Active Ingredient(s): | 20 mg/1 & nbsp; isotretinoin | 
| Administration Route(s): | ORAL | 
| Dosage Form(s): | CAPSULE | 
| Coding System: | National Drug Codes(NDC) | 
| Product NDC: | 0555-1055 | 
| Labeler Name: | Barr Laboratories, Inc. | 
| Product Type: | HUMAN PRESCRIPTION DRUG | 
| FDA Application Number: | ANDA076135 | 
| Marketing Category: | ANDA | 
| Start Marketing Date: | 20030509 | 
| Package NDC: | 0555-1055-56 | 
| Package Description: | 10 BLISTER PACK in 1 CARTON (0555-1055-56) > 10 CAPSULE in 1 BLISTER PACK | 
| NDC Code | 0555-1055-56 | 
| Proprietary Name | Claravis | 
| Package Description | 10 BLISTER PACK in 1 CARTON (0555-1055-56) > 10 CAPSULE in 1 BLISTER PACK | 
| Product NDC | 0555-1055 | 
| Product Type Name | HUMAN PRESCRIPTION DRUG | 
| Non Proprietary Name | isotretinoin | 
| Dosage Form Name | CAPSULE | 
| Route Name | ORAL | 
| Start Marketing Date | 20030509 | 
| Marketing Category Name | ANDA | 
| Labeler Name | Barr Laboratories, Inc. | 
| Substance Name | ISOTRETINOIN | 
| Strength Number | 20 | 
| Strength Unit | mg/1 | 
| Pharmaceutical Classes | Retinoid [EPC],Retinoids [Chemical/Ingredient] |