Phentermine hydrochloride
- Product NDC
- 17224-904
- Requested package NDC
- 17224-904-28
- 11-digit product format
- 172240904
- Labeler code
- 17224
- Product ID
- 17224-904_f6e232c2-4182-6274-e053-6294a90a5e38
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- PHENTERMINE HYDROCHLORIDE
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Calvin Scott & Co., Inc.
- Application
- ANDA205008
- Marketing category
- ANDA
- Marketing start
- 2017-01-24
- Substance
- PHENTERMINE HYDROCHLORIDE
- Active strength
- 37.5 mg/1
- Pharmacologic classes
- Appetite Suppression [PE], Increased Sympathetic Activity [PE], Sympathomimetic Amine Anorectic [EPC]
- DEA schedule
- CIV
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Observed NDC auxiliary status history#
This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
| Captured / source date | Snapshot | Source SHA-256 |
|---|---|---|
| 2022-08-30 03:57 UTC · source 2022-08-29 | fb8cb913e6d1… | eb8c232b6be0… |
| 2022-04-09 23:13 UTC · source 2022-04-08 | 86f5da6cb304… | a595104c45d7… |
| 2022-04-04 05:40 UTC · source 2022-04-01 | bd6a592717d7… | 303034d00443… |
| 2021-12-27 23:28 UTC · source 2021-12-27 | 8dfbde2a14a4… | c9ff85d89658… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A205008-001 | PHENTERMINE HYDROCHLORIDE | PHENTERMINE HYDROCHLORIDE | 37.5MG | TABLET / ORAL | AA | 2014-09-25 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A205008-001 | AA |
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 | A205008-001 | PHENTERMINE HYDROCHLORIDE | 37.5MG | TABLET / ORAL | AA | 2014-09-25 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A205008-001 | PHENTERMINE HYDROCHLORIDE | 37.5MG | TABLET / ORAL | AA | 2014-09-25 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A205008-001 | PHENTERMINE HYDROCHLORIDE | 37.5MG | TABLET / ORAL | AA | 2014-09-25 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A205008-001 | PHENTERMINE HYDROCHLORIDE | 37.5MG | TABLET / ORAL | AA | 2014-09-25 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A205008-001 | PHENTERMINE HYDROCHLORIDE | 37.5MG | TABLET / ORAL | AA | 2014-09-25 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A205008-001 | PHENTERMINE HYDROCHLORIDE | 37.5MG | TABLET / ORAL | AA | 2014-09-25 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A205008-001 | PHENTERMINE HYDROCHLORIDE | 37.5MG | TABLET / ORAL | AA | 2014-09-25 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A205008-001 | PHENTERMINE HYDROCHLORIDE | 37.5MG | TABLET / ORAL | AA | 2014-09-25 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A205008-001 | PHENTERMINE HYDROCHLORIDE | 37.5MG | TABLET / ORAL | AA | 2014-09-25 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A205008-001 | PHENTERMINE HYDROCHLORIDE | 37.5MG | TABLET / ORAL | AA | 2014-09-25 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A205008-001 | PHENTERMINE HYDROCHLORIDE | 37.5MG | TABLET / ORAL | AA | 2014-09-25 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A205008-001 | PHENTERMINE HYDROCHLORIDE | 37.5MG | TABLET / ORAL | AA | 2014-09-25 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A205008-001 | PHENTERMINE HYDROCHLORIDE | 37.5MG | TABLET / ORAL | AA | 2014-09-25 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A205008-001 | PHENTERMINE HYDROCHLORIDE | 37.5MG | TABLET / ORAL | AA | 2014-09-25 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A205008-001 | PHENTERMINE HYDROCHLORIDE | 37.5MG | TABLET / ORAL | AA | 2014-09-25 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A205008-001 | PHENTERMINE HYDROCHLORIDE | 37.5MG | TABLET / ORAL | AA | 2014-09-25 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A205008-001 | PHENTERMINE HYDROCHLORIDE | 37.5MG | TABLET / ORAL | AA | 2014-09-25 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A205008-001 | PHENTERMINE HYDROCHLORIDE | 37.5MG | TABLET / ORAL | AA | 2014-09-25 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A205008-001 | PHENTERMINE HYDROCHLORIDE | 37.5MG | TABLET / ORAL | AA | 2014-09-25 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | A205008-001 | PHENTERMINE HYDROCHLORIDE | 37.5MG | TABLET / ORAL | AA | 2014-09-25 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A205008-001 | PHENTERMINE HYDROCHLORIDE | 37.5MG | TABLET / ORAL | AA | 2014-09-25 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | A205008-001 | PHENTERMINE HYDROCHLORIDE | 37.5MG | TABLET / ORAL | AA | 2014-09-25 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | A205008-001 | PHENTERMINE HYDROCHLORIDE | 37.5MG | TABLET / ORAL | AA | 2014-09-25 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | A205008-001 | PHENTERMINE HYDROCHLORIDE | 37.5MG | TABLET / ORAL | AA | 2014-09-25 | c0c555d07b60… | |
| 2019-12-14 00:12 UTC | 2019-12 | A205008-001 | PHENTERMINE HYDROCHLORIDE | 37.5MG | TABLET / ORAL | AA | 2014-09-25 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | A205008-001 | PHENTERMINE HYDROCHLORIDE | 37.5MG | TABLET / ORAL | AA | 2014-09-25 | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | A205008-001 | PHENTERMINE HYDROCHLORIDE | 37.5MG | TABLET / ORAL | AA | 2014-09-25 | ea99ee380514… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A205008-001 | PHENTERMINE HYDROCHLORIDE | 37.5MG | TABLET / ORAL | AA | 2014-09-25 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | A205008-001 | PHENTERMINE HYDROCHLORIDE | 37.5MG | TABLET / ORAL | AA | 2014-09-25 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | A205008-001 | PHENTERMINE HYDROCHLORIDE | 37.5MG | TABLET / ORAL | AA | 2014-09-25 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A205008-001 | PHENTERMINE HYDROCHLORIDE | 37.5MG | TABLET / ORAL | AA | 2014-09-25 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A205008-001 | PHENTERMINE HYDROCHLORIDE | 37.5MG | TABLET / ORAL | AA | 2014-09-25 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A205008-001 | PHENTERMINE HYDROCHLORIDE | 37.5MG | TABLET / ORAL | AA | 2014-09-25 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A205008-001 | PHENTERMINE HYDROCHLORIDE | 37.5MG | TABLET / ORAL | AA | 2014-09-25 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | A205008-001 | PHENTERMINE HYDROCHLORIDE | 37.5MG | TABLET / ORAL | AA | 2014-09-25 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | A205008-001 | PHENTERMINE HYDROCHLORIDE | 37.5MG | TABLET / ORAL | AA | 2014-09-25 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A205008-001 | PHENTERMINE HYDROCHLORIDE | 37.5MG | TABLET / ORAL | AA | 2014-09-25 | 3a93d1ddd44b… | |
| 2022-10-28 04:53 UTC | 2022-10 | A205008-001 | PHENTERMINE HYDROCHLORIDE | 37.5MG | TABLET / ORAL | AA | 2014-09-25 | f41ea6bd6efb… | |
| 2022-09-29 23:25 UTC | 2022-09 | A205008-001 | PHENTERMINE HYDROCHLORIDE | 37.5MG | TABLET / ORAL | AA | 2014-09-25 | e64feba35796… | |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A205008-001 | PHENTERMINE HYDROCHLORIDE | 37.5MG | TABLET / ORAL | AA | 2014-09-25 | 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 | A205008-001 | AA | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A205008-001 | AA | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A205008-001 | AA | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A205008-001 | AA | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A205008-001 | AA | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A205008-001 | AA | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A205008-001 | AA | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A205008-001 | AA | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A205008-001 | AA | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A205008-001 | AA | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A205008-001 | AA | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A205008-001 | AA | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A205008-001 | AA | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A205008-001 | AA | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A205008-001 | AA | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A205008-001 | AA | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A205008-001 | AA | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A205008-001 | AA | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A205008-001 | AA | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A205008-001 | AA | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A205008-001 | AA | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A205008-001 | AA | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A205008-001 | AA | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A205008-001 | AA | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A205008-001 | AA | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A205008-001 | AA | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A205008-001 | AA | 1 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A205008-001 | AA | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A205008-001 | AA | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A205008-001 | AA | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A205008-001 | AA | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A205008-001 | AA | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A205008-001 | AA | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A205008-001 | AA | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | A205008-001 | AA | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | A205008-001 | AA | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A205008-001 | AA | 1 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | A205008-001 | AA | 1 | f41ea6bd6efb… |
| 2022-09-29 23:25 UTC | 2022-09 | A205008-001 | AA | 1 | e64feba35796… |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A205008-001 | AA | 1 | cb3db0bc1861… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Phentermine hydrochloride
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| PHENTERMINE HYDROCHLORIDE | 37.5 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 0K2I505OTV | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 803353 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 3d1d4dde-1c7f-4a20-b8f8-897b1b284f80 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 3d272a3f-17c0-421d-bc43-3cbdb719258d | Product name | 1 | 20250303 |
| 32c2b0bd-1f13-4890-99e0-dcd2ea16e1ab | Product name | 2 | 20230717 |
| ebeae3eb-385d-62da-8827-5ffa80b14e90 | Product name | 2 | 20170810 |
| 1d682039-1122-1cb7-f3f4-c0a028b98748 | Product name | 4 | 20170124 |
| 8ef9ca65-1a6c-7225-351d-36066d0f8e56 | Product name | 3 | 20161229 |
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 17224-904-07 | Phentermine hydrochloride | 7 in 1 BOTTLE | TABLET | 7 | 2 | |
| 17224-904-28 | Phentermine hydrochloride | 28 in 1 BOTTLE | TABLET | 28 | 2 | |
| 17224-904-30 | Phentermine hydrochloride | 30 in 1 BOTTLE | TABLET | 30 | 2 | |
| 17224-904-60 | Phentermine hydrochloride | 60 in 1 BOTTLE | TABLET | 60 | 2 |
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 |
|---|---|---|---|---|---|---|
| Phentermine hydrochloride | PHENTERMINE HYDROCHLORIDE | Calvin Scott & Co., Inc. | 3d1d4dde-1c7f-4a20-b8f8-897b1b284f80 | 2026-05-21 | Warnings, Adverse reactions | 205008 ANDA205008 17224-904-28 17224-904 17224090428 |
| Phentermine hydrochloride | PHENTERMINE HYDROCHLORIDE | Bryant Ranch Prepack | 9155edf8-ea1d-458f-b2a7-e0303fd83cc0 | 2026-03-16 | Warnings, Adverse reactions | 205008 ANDA205008 |
| Phentermine hydrochloride | PHENTERMINE HYDROCHLORIDE | Preferred Pharmaceuticals Inc. | 129e781c-5366-4986-8e67-6b35fa4c3f39 | 2025-09-09 | Warnings, Adverse reactions | 205008 ANDA205008 |
| Phentermine hydrochloride | PHENTERMINE HYDROCHLORIDE | Bryant Ranch Prepack | e08b4f49-de9f-490d-b11d-d865439f5fad | 2025-01-31 | Warnings, Adverse reactions | 205008 ANDA205008 |
| Phentermine hydrochloride | PHENTERMINE HYDROCHLORIDE | Bryant Ranch Prepack | e0a6a289-7dbf-4b24-b815-46dee0d19fdc | 2025-01-24 | Warnings, Adverse reactions | 205008 ANDA205008 |
| Phentermine hydrochloride | PHENTERMINE HYDROCHLORIDE | Bryant Ranch Prepack | 99c1325b-7152-481d-8a1f-6bf3e2c4808b | 2025-01-24 | Warnings, Adverse reactions | 205008 ANDA205008 |
| Phentermine hydrochloride | PHENTERMINE HYDROCHLORIDE | SUNRISE PHARMACEUTICAL, INC. | 43024f64-2d77-49a9-80fd-ad07a86c69a3 | 2024-12-03 | Warnings, Adverse reactions | 205008 ANDA205008 |
| Phentermine hydrochloride | PHENTERMINE HYDROCHLORIDE | Bryant Ranch Prepack | 50efa498-11c5-41fa-95ac-419fcc10da03 | 2024-11-01 | Warnings, Adverse reactions | 205008 ANDA205008 |
| Phentermine hydrochloride | PHENTERMINE HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | 1fa8798d-c096-5839-e063-6394a90aa28b | 2024-09-03 | Warnings, Adverse reactions | 205008 ANDA205008 |
| Phentermine hydrochloride | PHENTERMINE HYDROCHLORIDE | Proficient Rx LP | 28fda2ce-d445-47ce-8764-bf113b5db5b3 | 2022-11-01 | Warnings, Adverse reactions | 205008 ANDA205008 |
| Phentermine hydrochloride | PHENTERMINE HYDROCHLORIDE | Asclemed USA, Inc. | de76ed27-ac43-4923-b73f-461d33941f6b | 2020-10-30 | Warnings, Adverse reactions | 205008 ANDA205008 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 803353 | phentermine HCl 37.5 MG Oral Tablet | PSN | 3d1d4dde-1c7f-4a20-b8f8-897b1b284f80 | 3 |
| 803353 | phentermine hydrochloride 37.5 MG Oral Tablet | SCD | 3d1d4dde-1c7f-4a20-b8f8-897b1b284f80 | 3 |
| 803353 | phentermine hydrochloride 37.5 MG (equivalent to phentermine 30 MG) Oral Tablet | SY | 3d1d4dde-1c7f-4a20-b8f8-897b1b284f80 | 3 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 17224-904-28 | 17224090428 | 28 TABLET in 1 BOTTLE (17224-904-28) | 28 tablet | 2017-01-24 | No | No | Current |