Isotretinoin 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.
| Product ID | 57664-020_b44200ba-6672-4ea7-b151-7caec3f53c9c |
| NDC | 57664-020 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Isotretinoin |
| Generic Name | Isotretinoin |
| Dosage Form | Capsule |
| Route of Administration | ORAL |
| Marketing Start Date | 2020-12-29 |
| Marketing Category | NDA AUTHORIZED GENERIC / NDA AUTHORIZED GENERIC |
| Application Number | NDA021951 |
| Labeler Name | Sun Pharmaceutical Industries, Inc. |
| Substance Name | ISOTRETINOIN |
| Active Ingredient Strength | 10 mg/1 |
| Pharm Classes | Retinoid [EPC],Retinoids [CS] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2021-12-31 |
| Marketing Start Date | 2020-12-29 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 0245-0570 | Isotretinoin | Isotretinoin |
| 0245-0571 | Isotretinoin | Isotretinoin |
| 0245-0573 | Isotretinoin | Isotretinoin |
| 0245-0575 | Isotretinoin | Isotretinoin |
| 69238-1017 | Isotretinoin | Isotretinoin |
| 69238-1174 | Isotretinoin | Isotretinoin |
| 69238-1175 | Isotretinoin | Isotretinoin |
| 69238-1176 | Isotretinoin | Isotretinoin |
| 57664-021 | Isotretinoin | Isotretinoin |
| 57664-023 | Isotretinoin | Isotretinoin |
| 57664-025 | Isotretinoin | Isotretinoin |
| 57664-020 | Isotretinoin | Isotretinoin |
| 57664-022 | Isotretinoin | Isotretinoin |
| 57664-024 | Isotretinoin | Isotretinoin |
| 0378-6611 | Amnesteem | isotretinoin |
| 0378-6612 | Amnesteem | isotretinoin |
| 0378-6614 | Amnesteem | isotretinoin |
| 0555-1054 | Claravis | Isotretinoin |
| 0555-1055 | Claravis | Isotretinoin |
| 0555-1056 | Claravis | Isotretinoin |
| 0555-1057 | Claravis | Isotretinoin |