Finasteride
- Product NDC
- 67877-455
- 11-digit product format
- 678770455
- Labeler code
- 67877
- Product ID
- 67877-455_f4ed6589-2062-48b0-8a0c-25b0342342c2
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Finasteride
- Dosage form
- TABLET, COATED
- Route
- ORAL
- Labeler
- Ascend Laboratories, LLC
- Application
- ANDA207750
- Marketing category
- ANDA
- Marketing start
- 2017-01-06
- Substance
- FINASTERIDE
- Active strength
- 1 mg/1
- Pharmacologic classes
- 5-alpha Reductase Inhibitor [EPC], 5-alpha Reductase Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A207750-001 | FINASTERIDE | FINASTERIDE | 1MG | TABLET / ORAL | AB | 2017-01-06 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A207750-001 | AB |
Observed Orange Book product history#
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A207750-001 | FINASTERIDE | 1MG | TABLET / ORAL | AB | 2017-01-06 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A207750-001 | FINASTERIDE | 1MG | TABLET / ORAL | AB | 2017-01-06 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A207750-001 | FINASTERIDE | 1MG | TABLET / ORAL | AB | 2017-01-06 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A207750-001 | FINASTERIDE | 1MG | TABLET / ORAL | AB | 2017-01-06 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A207750-001 | FINASTERIDE | 1MG | TABLET / ORAL | AB | 2017-01-06 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A207750-001 | FINASTERIDE | 1MG | TABLET / ORAL | AB | 2017-01-06 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A207750-001 | FINASTERIDE | 1MG | TABLET / ORAL | AB | 2017-01-06 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A207750-001 | FINASTERIDE | 1MG | TABLET / ORAL | AB | 2017-01-06 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A207750-001 | FINASTERIDE | 1MG | TABLET / ORAL | AB | 2017-01-06 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A207750-001 | FINASTERIDE | 1MG | TABLET / ORAL | AB | 2017-01-06 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A207750-001 | FINASTERIDE | 1MG | TABLET / ORAL | AB | 2017-01-06 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A207750-001 | FINASTERIDE | 1MG | TABLET / ORAL | AB | 2017-01-06 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A207750-001 | FINASTERIDE | 1MG | TABLET / ORAL | AB | 2017-01-06 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A207750-001 | FINASTERIDE | 1MG | TABLET / ORAL | AB | 2017-01-06 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A207750-001 | FINASTERIDE | 1MG | TABLET / ORAL | AB | 2017-01-06 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A207750-001 | FINASTERIDE | 1MG | TABLET / ORAL | AB | 2017-01-06 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A207750-001 | FINASTERIDE | 1MG | TABLET / ORAL | AB | 2017-01-06 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A207750-001 | FINASTERIDE | 1MG | TABLET / ORAL | AB | 2017-01-06 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A207750-001 | FINASTERIDE | 1MG | TABLET / ORAL | AB | 2017-01-06 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | A207750-001 | FINASTERIDE | 1MG | TABLET / ORAL | AB | 2017-01-06 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A207750-001 | FINASTERIDE | 1MG | TABLET / ORAL | AB | 2017-01-06 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | A207750-001 | FINASTERIDE | 1MG | TABLET / ORAL | AB | 2017-01-06 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | A207750-001 | FINASTERIDE | 1MG | TABLET / ORAL | AB | 2017-01-06 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | A207750-001 | FINASTERIDE | 1MG | TABLET / ORAL | AB | 2017-01-06 | c0c555d07b60… | |
| 2019-12-14 00:12 UTC | 2019-12 | A207750-001 | FINASTERIDE | 1MG | TABLET / ORAL | AB | 2017-01-06 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | A207750-001 | FINASTERIDE | 1MG | TABLET / ORAL | AB | 2017-01-06 | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | A207750-001 | FINASTERIDE | 1MG | TABLET / ORAL | AB | 2017-01-06 | ea99ee380514… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A207750-001 | FINASTERIDE | 1MG | TABLET / ORAL | AB | 2017-01-06 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | A207750-001 | FINASTERIDE | 1MG | TABLET / ORAL | AB | 2017-01-06 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | A207750-001 | FINASTERIDE | 1MG | TABLET / ORAL | AB | 2017-01-06 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A207750-001 | FINASTERIDE | 1MG | TABLET / ORAL | AB | 2017-01-06 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A207750-001 | FINASTERIDE | 1MG | TABLET / ORAL | AB | 2017-01-06 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A207750-001 | FINASTERIDE | 1MG | TABLET / ORAL | AB | 2017-01-06 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A207750-001 | FINASTERIDE | 1MG | TABLET / ORAL | AB | 2017-01-06 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | A207750-001 | FINASTERIDE | 1MG | TABLET / ORAL | AB | 2017-01-06 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | A207750-001 | FINASTERIDE | 1MG | TABLET / ORAL | AB | 2017-01-06 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A207750-001 | FINASTERIDE | 1MG | TABLET / ORAL | AB | 2017-01-06 | 3a93d1ddd44b… | |
| 2022-10-28 04:53 UTC | 2022-10 | A207750-001 | FINASTERIDE | 1MG | TABLET / ORAL | AB | 2017-01-06 | f41ea6bd6efb… | |
| 2022-09-29 23:25 UTC | 2022-09 | A207750-001 | FINASTERIDE | 1MG | TABLET / ORAL | AB | 2017-01-06 | e64feba35796… | |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A207750-001 | FINASTERIDE | 1MG | TABLET / ORAL | AB | 2017-01-06 | cb3db0bc1861… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A207750-001 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A207750-001 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A207750-001 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A207750-001 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A207750-001 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A207750-001 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A207750-001 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A207750-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A207750-001 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A207750-001 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A207750-001 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A207750-001 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A207750-001 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A207750-001 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A207750-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A207750-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A207750-001 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A207750-001 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A207750-001 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A207750-001 | AB | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A207750-001 | AB | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A207750-001 | AB | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A207750-001 | AB | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A207750-001 | AB | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A207750-001 | AB | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A207750-001 | AB | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A207750-001 | AB | 1 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A207750-001 | AB | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A207750-001 | AB | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A207750-001 | AB | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A207750-001 | AB | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A207750-001 | AB | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A207750-001 | AB | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A207750-001 | AB | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | A207750-001 | AB | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | A207750-001 | AB | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A207750-001 | AB | 1 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | A207750-001 | AB | 1 | f41ea6bd6efb… |
| 2022-09-29 23:25 UTC | 2022-09 | A207750-001 | AB | 1 | e64feba35796… |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A207750-001 | AB | 1 | cb3db0bc1861… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Finasteride
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| FINASTERIDE | 1 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 57GNO57U7G | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 200172 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| ecd2fbb2-a4bd-44f2-831d-179e7dbf0741 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 928d249c-35c3-4d88-a9ef-cf2f2e31b96f | Product name | 1 | 20220706 |
| d00474ae-23eb-a8eb-bf56-520e590cc6db | Product name | 2 | 20170406 |
| 0f90664c-9d0e-f046-dc6a-73563cd8347e | Product name | 2 | 20170405 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 67877-455-05 | Finasteride | 500 in 1 BOTTLE | TABLET, COATED | 500 | 16 | |
| 67877-455-30 | Finasteride | 30 in 1 BOTTLE | TABLET, COATED | 30 | 16 | |
| 67877-455-34 | Finasteride | 10 in 1 BLISTER PACK | TABLET, COATED | 10 | 16 | |
| 67877-455-90 | Finasteride | 90 in 1 BOTTLE | TABLET, COATED | 90 | 16 | |
| 67877-455-94 | Finasteride | 3 in 1 CARTON | TABLET, COATED | 3 | 16 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 67877-455-05 | EA - Each | 67877-455 | deb69016-78ea-45da-a41b-234079ced4eb | 1 | 2025-02-10 |
| 67877-455-30 | EA - Each | 67877-455 | 60946042-ac11-4f5b-8c03-d73aea1a7594 | 1 | 2017-05-04 |
| 67877-455-90 | EA - Each | 67877-455 | 740e41d8-9592-489b-9353-190d48ad5455 | 1 | 2017-05-04 |
DailyMed Dashboard NDC Coverage#
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Finasteride | FINASTERIDE | REMEDYREPACK INC. | 90cc0d22-fa5c-4fe4-b0bf-554b715a05ac | 2026-07-09 | Warnings, Adverse reactions | 207750 ANDA207750 |
| Finasteride | FINASTERIDE | A-S Medication Solutions | 49eb3a1e-d7e6-4652-aa6d-6abf21af34a6 | 2026-03-26 | Warnings, Adverse reactions | 207750 ANDA207750 |
| Finasteride | FINASTERIDE | Preferred Pharmaceuticals Inc. | b84a67d6-695e-4a7c-9b60-95e9ad18a501 | 2026-01-15 | Warnings, Adverse reactions | 207750 ANDA207750 |
| Finasteride | FINASTERIDE | Ascend Laboratories, LLC | ecd2fbb2-a4bd-44f2-831d-179e7dbf0741 | 2025-04-24 | Warnings, Adverse reactions | 207750 ANDA207750 67877-455 |
| Finasteride | FINASTERIDE | NuCare Pharmaceuticals, Inc. | 291a2037-2b4f-a2fe-e063-6294a90a1e9a | 2024-12-24 | Warnings, Adverse reactions | 207750 ANDA207750 |
| Finasteride | FINASTERIDE | Bryant Ranch Prepack | 3e955ce4-d44e-4b4d-b763-ab141cb3f06d | 2024-08-23 | Warnings, Adverse reactions | 207750 ANDA207750 |
| Finasteride | FINASTERIDE | Proficient Rx LP | 196f7d23-ed90-46c2-ae34-615e6ec1650b | 2023-04-01 | Warnings, Adverse reactions | 207750 ANDA207750 |
| Finasteride | FINASTERIDE | Thirty Madison Inc | 3fe7bdaa-b027-4da9-94ee-550bf28c63e1 | 2021-04-08 | Warnings, Adverse reactions | 207750 ANDA207750 |
DailyMed RxNorm Mappings#
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 67877-455-05 | 67877045505 | 500 TABLET, COATED in 1 BOTTLE (67877-455-05) | 2025-01-31 | 0000-00-00 | No | No | Current | |
| 67877-455-30 | 67877045530 | 30 TABLET, COATED in 1 BOTTLE (67877-455-30) | 2017-01-06 | 0000-00-00 | No | No | Current | |
| 67877-455-34 | 67877045534 | 10 in 1 BLISTER PACK | Historical | |||||
| 67877-455-90 | 67877045590 | 90 TABLET, COATED in 1 BOTTLE (67877-455-90) | 2017-01-06 | 0000-00-00 | No | No | Current | |
| 67877-455-94 | 67877045594 | 3 BLISTER PACK in 1 CARTON (67877-455-94) / 10 TABLET, COATED in 1 BLISTER PACK (67877-455-34) | 3 blister pack | 2017-01-06 | 0000-00-00 | No | No | Current |