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NDC 00555-0808-02 Tretinoin 10 mg/1 Details
Tretinoin 10 mg/1
Tretinoin is a ORAL CAPSULE, LIQUID FILLED in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Teva Pharmaceuticals USA, Inc.. The primary component is TRETINOIN.
MedlinePlus Drug Summary
Tretinoin is used to treat acute promyelocytic leukemia (APL; a type of cancer in which there are too many immature blood cells in the blood and bone marrow) in people who have not been helped by other types of chemotherapy or whose condition has improved but then worsened following treatment with other types of chemotherapy. Tretinoin is used to produce remission (a decrease or disappearance of signs and symptoms of cancer) of APL, but other medications must be used after treatment with tretinoin to prevent the cancer from returning. Tretinoin is in a class of medications called retinoids. It works by slowing or stopping the growth of cancer cells by causing immature blood cells to develop into normal blood cells.
Related Packages: 00555-0808-02Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Tretinoin
Product Information
| NDC | 00555-0808 |
|---|---|
| Product ID | 0555-0808_48f08c97-20c2-404a-a05f-84dada1ec42d |
| Associated GPIs | 21708080000110 |
| GCN Sequence Number | 024466 |
| GCN Sequence Number Description | tretinoin CAPSULE 10 MG ORAL |
| HIC3 | V1F |
| HIC3 Description | ANTINEOPLASTICS,MISCELLANEOUS |
| GCN | 48590 |
| HICL Sequence Number | 002468 |
| HICL Sequence Number Description | TRETINOIN |
| Brand/Generic | Generic |
| Proprietary Name | Tretinoin |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Tretinoin |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | CAPSULE, LIQUID FILLED |
| Route | ORAL |
| Active Ingredient Strength | 10 |
| Active Ingredient Units | mg/1 |
| Substance Name | TRETINOIN |
| Labeler Name | Teva Pharmaceuticals USA, Inc. |
| Pharmaceutical Class | Retinoid [EPC], Retinoids [CS] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA077684 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 00555-0808-02 (00555080802)
| NDC Package Code | 0555-0808-02 |
|---|---|
| Billing NDC | 00555080802 |
| Package | 100 CAPSULE, LIQUID FILLED in 1 BOTTLE (0555-0808-02) |
| Marketing Start Date | 2007-06-26 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |