Phentermine Hydrochloride
- Product NDC
- 70771-1200
- 11-digit product format
- 707711200
- Labeler code
- 70771
- Product ID
- 70771-1200_e370bf4e-553c-4fe6-84ef-2a20fbd9e2ee
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Phentermine Hydrochloride
- Dosage form
- TABLET, ORALLY DISINTEGRATING
- Route
- ORAL
- Labeler
- Zydus Lifesciences Limited
- Application
- ANDA204663
- Marketing category
- ANDA
- Marketing start
- 2018-02-08
- 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 | 70771-1200 | D | Discontinued by firm | 2026-10-16 | ||
| excluded package | package | 70771-1200 | 70771-1200-0 | D | Discontinued by firm | 2026-10-16 | |
| excluded package | package | 70771-1200 | 70771-1200-1 | D | Discontinued by firm | 2026-10-16 | |
| excluded package | package | 70771-1200 | 70771-1200-3 | D | Discontinued by firm | 2026-10-16 | |
| excluded package | package | 70771-1200 | 70771-1200-4 | D | Discontinued by firm | 2026-10-16 | |
| excluded package | package | 70771-1200 | 70771-1200-5 | D | Discontinued by firm | 2026-10-16 | |
| excluded package | package | 70771-1200 | 70771-1200-9 | D | Discontinued by firm | 2026-10-16 |
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 | 70771-1200-9 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 70771-1200-1 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 70771-1200-0 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 70771-1200-4 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 70771-1200-3 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 70771-1200-5 | 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 | 70771-1200-9 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 70771-1200-1 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 70771-1200-0 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 70771-1200-4 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 70771-1200-3 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 70771-1200-5 | f5e01cc5f278… | a2eaf40c39c3… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A204663-001 | PHENTERMINE HYDROCHLORIDE | PHENTERMINE HYDROCHLORIDE | 15MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2017-06-28 | ||
| A204663-002 | PHENTERMINE HYDROCHLORIDE | PHENTERMINE HYDROCHLORIDE | 30MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2017-06-28 | ||
| A204663-003 | PHENTERMINE HYDROCHLORIDE | PHENTERMINE HYDROCHLORIDE | 37.5MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2017-06-28 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | A204663-001 | PHENTERMINE HYDROCHLORIDE | 15MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2017-06-28 | c2088c7a36db… | ||
| 2026-10-15 13:18:30 | 2026-09 | A204663-002 | PHENTERMINE HYDROCHLORIDE | 30MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2017-06-28 | c2088c7a36db… | ||
| 2026-10-15 13:18:30 | 2026-09 | A204663-003 | PHENTERMINE HYDROCHLORIDE | 37.5MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2017-06-28 | c2088c7a36db… | ||
| 2026-09-14 22:38:34 | 2026-08 | A204663-001 | PHENTERMINE HYDROCHLORIDE | 15MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2017-06-28 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A204663-002 | PHENTERMINE HYDROCHLORIDE | 30MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2017-06-28 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A204663-003 | PHENTERMINE HYDROCHLORIDE | 37.5MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2017-06-28 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A204663-001 | PHENTERMINE HYDROCHLORIDE | 15MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2017-06-28 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A204663-002 | PHENTERMINE HYDROCHLORIDE | 30MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2017-06-28 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A204663-003 | PHENTERMINE HYDROCHLORIDE | 37.5MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2017-06-28 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A204663-001 | PHENTERMINE HYDROCHLORIDE | 15MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2017-06-28 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A204663-002 | PHENTERMINE HYDROCHLORIDE | 30MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2017-06-28 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A204663-003 | PHENTERMINE HYDROCHLORIDE | 37.5MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2017-06-28 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204663-001 | PHENTERMINE HYDROCHLORIDE | 15MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2017-06-28 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204663-002 | PHENTERMINE HYDROCHLORIDE | 30MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2017-06-28 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204663-003 | PHENTERMINE HYDROCHLORIDE | 37.5MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2017-06-28 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A204663-001 | PHENTERMINE HYDROCHLORIDE | 15MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2017-06-28 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A204663-002 | PHENTERMINE HYDROCHLORIDE | 30MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2017-06-28 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A204663-003 | PHENTERMINE HYDROCHLORIDE | 37.5MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2017-06-28 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204663-001 | PHENTERMINE HYDROCHLORIDE | 15MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2017-06-28 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204663-002 | PHENTERMINE HYDROCHLORIDE | 30MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2017-06-28 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204663-003 | PHENTERMINE HYDROCHLORIDE | 37.5MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2017-06-28 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204663-001 | PHENTERMINE HYDROCHLORIDE | 15MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2017-06-28 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204663-002 | PHENTERMINE HYDROCHLORIDE | 30MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2017-06-28 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204663-003 | PHENTERMINE HYDROCHLORIDE | 37.5MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2017-06-28 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204663-001 | PHENTERMINE HYDROCHLORIDE | 15MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2017-06-28 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204663-002 | PHENTERMINE HYDROCHLORIDE | 30MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2017-06-28 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204663-003 | PHENTERMINE HYDROCHLORIDE | 37.5MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2017-06-28 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A204663-001 | PHENTERMINE HYDROCHLORIDE | 15MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2017-06-28 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A204663-002 | PHENTERMINE HYDROCHLORIDE | 30MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2017-06-28 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A204663-003 | PHENTERMINE HYDROCHLORIDE | 37.5MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2017-06-28 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A204663-001 | PHENTERMINE HYDROCHLORIDE | 15MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2017-06-28 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A204663-002 | PHENTERMINE HYDROCHLORIDE | 30MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2017-06-28 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A204663-003 | PHENTERMINE HYDROCHLORIDE | 37.5MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2017-06-28 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A204663-001 | PHENTERMINE HYDROCHLORIDE | 15MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2017-06-28 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A204663-002 | PHENTERMINE HYDROCHLORIDE | 30MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2017-06-28 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A204663-003 | PHENTERMINE HYDROCHLORIDE | 37.5MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2017-06-28 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A204663-001 | PHENTERMINE HYDROCHLORIDE | 15MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2017-06-28 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A204663-002 | PHENTERMINE HYDROCHLORIDE | 30MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2017-06-28 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A204663-003 | PHENTERMINE HYDROCHLORIDE | 37.5MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2017-06-28 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A204663-001 | PHENTERMINE HYDROCHLORIDE | 15MG | TABLET, ORALLY DISINTEGRATING / ORAL | 2017-06-28 | 79d66fd596c7… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 70771-1200-0 | 70771120000 | 1000 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (70771-1200-0) | 2018-02-08 | 0000-00-00 | No | No | Current | |
| 70771-1200-1 | 70771120001 | 100 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (70771-1200-1) | 2018-02-08 | 0000-00-00 | No | No | Current | |
| 70771-1200-3 | 70771120003 | 30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (70771-1200-3) | 2018-02-08 | 0000-00-00 | No | No | Current | |
| 70771-1200-4 | 70771120004 | 10 BLISTER PACK in 1 CARTON (70771-1200-4) > 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (70771-1200-2) | 10 blister pack | 2018-02-08 | 0000-00-00 | No | No | Current |
| 70771-1200-5 | 70771120005 | 500 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (70771-1200-5) | 2018-02-08 | 0000-00-00 | No | No | Current | |
| 70771-1200-9 | 70771120009 | 90 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (70771-1200-9) | 2018-02-08 | 0000-00-00 | No | No | Current |