Phentermine Hydrochloride
- Product NDC
- 0527-1742
- 11-digit product format
- 005271742
- Labeler code
- 0527
- Product ID
- 0527-1742_13517af4-9eee-422d-ae02-2a0f09101d74
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Phentermine Hydrochloride
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Lannett Company, Inc.
- Application
- ANDA087022
- Marketing category
- ANDA
- Marketing start
- 2012-01-20
- Marketing end
- 0000-00-00
- Substance
- PHENTERMINE HYDROCHLORIDE
- Active strength
- 15 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
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
NDC auxiliary status#
These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded product | product | 0527-1742 | D | Discontinued by firm | 2026-08-07 | ||
| excluded package | package | 0527-1742 | 0527-1742-01 | D | Discontinued by firm | 2026-08-07 | |
| excluded package | package | 0527-1742 | 0527-1742-10 | D | Discontinued by firm | 2026-08-07 |
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 | Dataset | Scope | Package NDC | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded product | product | d630ba8d3edf… | 732f749b63fb… | |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 0527-1742-10 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 0527-1742-01 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded product | product | f5e01cc5f278… | a2eaf40c39c3… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 0527-1742-10 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 0527-1742-01 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded product | product | 2ef7874e63bc… | 57b86245f4fa… | |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 0527-1742-10 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 0527-1742-01 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded product | product | a1b67e2a42f9… | c4cf2c586c0d… | |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 0527-1742-10 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 0527-1742-01 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded product | product | cfe11265f3b6… | 090c488252e2… | |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 0527-1742-10 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 0527-1742-01 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded product | product | cdf11ea48f46… | ba0047e9e063… | |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 0527-1742-10 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 0527-1742-01 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded product | product | 302b2466d912… | e7b80fea0513… | |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 0527-1742-10 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 0527-1742-01 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded product | product | ed331223b511… | 672a5bd82f5f… | |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 0527-1742-10 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 0527-1742-01 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded product | product | 0efc9e666f02… | f202fb6c5f17… | |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 0527-1742-10 | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 0527-1742-01 | 0efc9e666f02… | f202fb6c5f17… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A087022-001 | PHENTERMINE HYDROCHLORIDE | PHENTERMINE HYDROCHLORIDE | 30MG | CAPSULE / ORAL | 1983-02-03 | ||
| A087022-002 | PHENTERMINE HYDROCHLORIDE | PHENTERMINE HYDROCHLORIDE | 15MG | CAPSULE / ORAL | 2012-01-20 |
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 | A087022-001 | PHENTERMINE HYDROCHLORIDE | 30MG | CAPSULE / ORAL | 1983-02-03 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A087022-002 | PHENTERMINE HYDROCHLORIDE | 15MG | CAPSULE / ORAL | 2012-01-20 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A087022-001 | PHENTERMINE HYDROCHLORIDE | 30MG | CAPSULE / ORAL | 1983-02-03 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A087022-002 | PHENTERMINE HYDROCHLORIDE | 15MG | CAPSULE / ORAL | 2012-01-20 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A087022-001 | PHENTERMINE HYDROCHLORIDE | 30MG | CAPSULE / ORAL | 1983-02-03 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A087022-002 | PHENTERMINE HYDROCHLORIDE | 15MG | CAPSULE / ORAL | 2012-01-20 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A087022-001 | PHENTERMINE HYDROCHLORIDE | 30MG | CAPSULE / ORAL | 1983-02-03 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A087022-002 | PHENTERMINE HYDROCHLORIDE | 15MG | CAPSULE / ORAL | 2012-01-20 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A087022-001 | PHENTERMINE HYDROCHLORIDE | 30MG | CAPSULE / ORAL | 1983-02-03 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A087022-002 | PHENTERMINE HYDROCHLORIDE | 15MG | CAPSULE / ORAL | 2012-01-20 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A087022-001 | PHENTERMINE HYDROCHLORIDE | 30MG | CAPSULE / ORAL | 1983-02-03 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A087022-002 | PHENTERMINE HYDROCHLORIDE | 15MG | CAPSULE / ORAL | 2012-01-20 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A087022-001 | PHENTERMINE HYDROCHLORIDE | 30MG | CAPSULE / ORAL | 1983-02-03 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A087022-002 | PHENTERMINE HYDROCHLORIDE | 15MG | CAPSULE / ORAL | 2012-01-20 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A087022-001 | PHENTERMINE HYDROCHLORIDE | 30MG | CAPSULE / ORAL | 1983-02-03 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A087022-002 | PHENTERMINE HYDROCHLORIDE | 15MG | CAPSULE / ORAL | 2012-01-20 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A087022-001 | PHENTERMINE HYDROCHLORIDE | 30MG | CAPSULE / ORAL | 1983-02-03 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A087022-002 | PHENTERMINE HYDROCHLORIDE | 15MG | CAPSULE / ORAL | 2012-01-20 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A087022-001 | PHENTERMINE HYDROCHLORIDE | 30MG | CAPSULE / ORAL | 1983-02-03 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A087022-002 | PHENTERMINE HYDROCHLORIDE | 15MG | CAPSULE / ORAL | 2012-01-20 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A087022-001 | PHENTERMINE HYDROCHLORIDE | 30MG | CAPSULE / ORAL | 1983-02-03 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A087022-002 | PHENTERMINE HYDROCHLORIDE | 15MG | CAPSULE / ORAL | 2012-01-20 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A087022-001 | PHENTERMINE HYDROCHLORIDE | 30MG | CAPSULE / ORAL | 1983-02-03 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A087022-002 | PHENTERMINE HYDROCHLORIDE | 15MG | CAPSULE / ORAL | 2012-01-20 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A087022-001 | PHENTERMINE HYDROCHLORIDE | 30MG | CAPSULE / ORAL | 1983-02-03 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A087022-002 | PHENTERMINE HYDROCHLORIDE | 15MG | CAPSULE / ORAL | 2012-01-20 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A087022-001 | PHENTERMINE HYDROCHLORIDE | 30MG | CAPSULE / ORAL | 1983-02-03 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A087022-002 | PHENTERMINE HYDROCHLORIDE | 15MG | CAPSULE / ORAL | 2012-01-20 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A087022-001 | PHENTERMINE HYDROCHLORIDE | 30MG | CAPSULE / ORAL | AA | 1983-02-03 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A087022-002 | PHENTERMINE HYDROCHLORIDE | 15MG | CAPSULE / ORAL | AA | 2012-01-20 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A087022-001 | PHENTERMINE HYDROCHLORIDE | 30MG | CAPSULE / ORAL | AA | 1983-02-03 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | A087022-002 | PHENTERMINE HYDROCHLORIDE | 15MG | CAPSULE / ORAL | AA | 2012-01-20 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A087022-001 | PHENTERMINE HYDROCHLORIDE | 30MG | CAPSULE / ORAL | AA | 1983-02-03 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | A087022-002 | PHENTERMINE HYDROCHLORIDE | 15MG | CAPSULE / ORAL | AA | 2012-01-20 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A087022-001 | PHENTERMINE HYDROCHLORIDE | 30MG | CAPSULE / ORAL | AA | 1983-02-03 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | A087022-002 | PHENTERMINE HYDROCHLORIDE | 15MG | CAPSULE / ORAL | AA | 2012-01-20 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A087022-001 | PHENTERMINE HYDROCHLORIDE | 30MG | CAPSULE / ORAL | AA | 1983-02-03 | bb7c543d1eb4… | |
| 2022-03-09 01:35 UTC | 2022-03 | A087022-002 | PHENTERMINE HYDROCHLORIDE | 15MG | CAPSULE / ORAL | AA | 2012-01-20 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | A087022-001 | PHENTERMINE HYDROCHLORIDE | 30MG | CAPSULE / ORAL | AA | 1983-02-03 | 782e0a99824c… | |
| 2021-12-28 21:50 UTC | 2021-12 | A087022-002 | PHENTERMINE HYDROCHLORIDE | 15MG | CAPSULE / ORAL | AA | 2012-01-20 | 782e0a99824c… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A087022-001 | AA | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A087022-002 | AA | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A087022-001 | AA | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A087022-002 | AA | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A087022-001 | AA | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A087022-002 | AA | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A087022-001 | AA | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A087022-002 | AA | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A087022-001 | AA | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A087022-002 | AA | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A087022-001 | AA | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A087022-002 | AA | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A087022-001 | AA | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A087022-002 | AA | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A087022-001 | AA | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | A087022-002 | AA | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A087022-001 | AA | 1 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | A087022-002 | AA | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A087022-001 | AA | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | A087022-002 | AA | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A087022-001 | AA | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | A087022-002 | AA | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A087022-001 | AA | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | A087022-002 | AA | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A087022-001 | AA | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A087022-002 | AA | 1 | ea99ee380514… |
| 2023-01-26 05:58 UTC | 2023-01 | A087022-001 | AA | 1 | 3bdfa0b2c4d7… |
| 2023-01-26 05:58 UTC | 2023-01 | A087022-002 | AA | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A087022-001 | AA | 1 | 3a93d1ddd44b… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A087022-002 | AA | 1 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | A087022-001 | AA | 1 | f41ea6bd6efb… |
| 2022-10-28 04:53 UTC | 2022-10 | A087022-002 | AA | 1 | f41ea6bd6efb… |
| 2022-09-29 23:25 UTC | 2022-09 | A087022-001 | AA | 1 | e64feba35796… |
| 2022-09-29 23:25 UTC | 2022-09 | A087022-002 | AA | 1 | e64feba35796… |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A087022-001 | AA | 1 | cb3db0bc1861… |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A087022-002 | AA | 1 | cb3db0bc1861… |
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 Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0527-1742-01 | EA - Each | 0527-1742 | cdb41324-4076-4e2e-ae83-50e48011dc29 | 1 | 2012-07-24 |
| 0527-1742-10 | EA - Each | 0527-1742 | 9f873108-90e7-4eb4-9550-b84ffb7ee6da | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 968766 | phentermine HCl 15 MG Oral Capsule | PSN | 35d26955-2ad7-4f84-9b51-6a573933a396 | 1 |
| 968766 | phentermine HCl 15 MG Oral Capsule | PSN | 8d4168dd-59fa-188d-e053-2995a90aab43 | 1 |
| 968766 | phentermine hydrochloride 15 MG Oral Capsule | SCD | 35d26955-2ad7-4f84-9b51-6a573933a396 | 1 |
| 968766 | phentermine hydrochloride 15 MG Oral Capsule | SCD | 8d4168dd-59fa-188d-e053-2995a90aab43 | 1 |
| 968766 | phentermine hydrochloride 15 MG (equivalent to phentermine 12 MG) Oral Capsule | SY | 35d26955-2ad7-4f84-9b51-6a573933a396 | 1 |
| 968766 | phentermine hydrochloride 15 MG (equivalent to phentermine 12 MG) Oral Capsule | SY | 8d4168dd-59fa-188d-e053-2995a90aab43 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0527-1742-01 | 00527174201 | 100 CAPSULE in 1 BOTTLE (0527-1742-01) | 100 capsule | 2012-01-20 | 0000-00-00 | No | No | Current |
| 0527-1742-10 | 00527174210 | 1000 CAPSULE in 1 BOTTLE (0527-1742-10) | 1000 capsule | 2012-01-20 | 0000-00-00 | No | No | Current |