DUTASTERIDE
- Product NDC
- 64980-224
- 11-digit product format
- 649800224
- Labeler code
- 64980
- Product ID
- 64980-224_16b3d389-02d6-4281-bae0-7b9b26415645
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- dutasteride
- Dosage form
- CAPSULE, LIQUID FILLED
- Route
- ORAL
- Labeler
- Rising Pharmaceuticals, Inc.
- Application
- ANDA202530
- Marketing category
- ANDA
- Marketing start
- 2015-11-20
- Marketing end
- 0000-00-00
- Substance
- DUTASTERIDE
- Active strength
- 1 mg/1
- Pharmacologic classes
- 5-alpha Reductase Inhibitor [EPC],5-alpha Reductase Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2019-12-31
- Current FDA listing
- Historical FDA.report record
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 64980-224-03 | 2024-03-15 | C162847 | 48780-1 | 9d75b9d0-52d5-f424-e053-dadaa90a57ce | df6fb96f-3b58-4c4b-8305-d110d8feb57f |
| 64980-224-09 | 2024-03-15 | C162847 | 48780-1 | 9d75b9d0-52d5-f424-e053-dadaa90a57ce | df6fb96f-3b58-4c4b-8305-d110d8feb57f |
| 64980-224-03 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-52d5-f424-e053-dadaa90a57ce | df6fb96f-3b58-4c4b-8305-d110d8feb57f |
| 64980-224-09 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-52d5-f424-e053-dadaa90a57ce | df6fb96f-3b58-4c4b-8305-d110d8feb57f |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 64980-224-03 | EA - Each | 64980-224 | c85d3ee5-efb3-4a3b-9abe-14c0b8936572 | 1 | 2015-12-02 |
| 64980-224-09 | EA - Each | 64980-224 | 376bf557-68e2-4d26-8e3f-fd9c0e8b77ea | 1 | 2015-12-02 |