Phentermine Hydrochloride

Product NDC: 53002-7930
Requested package NDC: 53002-7930-3
11-digit product format: 530027930
Labeler code: 53002
Product ID: 53002-7930_7ff6892f-a5a4-4e00-b93f-4ebf5f1790f3
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Phentermine Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: RPK Pharmaceuticals, Inc.
Application: ANDA040555
Marketing category: ANDA
Marketing start: 2005-04-15
Marketing end: 0000-00-00
Substance: PHENTERMINE HYDROCHLORIDE
Active strength: 38 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: 2021-12-31
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.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	53002-7930	53002-7930-3	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.

Historic NDC status page 1 of 1 · 14 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Code, Status table
Captured / source date	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2020-12-18 03:04 UTC · source 2020-12-17	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A040555-001	PHENTERMINE HYDROCHLORIDE	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL			2005-04-15

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.

Product history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A040555-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL		2005-04-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040555-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL		2005-04-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040555-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL		2005-04-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040555-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL		2005-04-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040555-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL		2005-04-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040555-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL		2005-04-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040555-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL		2005-04-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040555-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL		2005-04-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040555-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL		2005-04-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040555-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL		2005-04-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040555-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL		2005-04-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040555-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL		2005-04-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040555-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL		2005-04-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040555-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL		2005-04-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040555-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2005-04-15	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040555-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2005-04-15	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040555-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2005-04-15	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040555-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2005-04-15	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040555-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2005-04-15	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040555-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2005-04-15	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040555-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2005-04-15	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040555-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2005-04-15	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040555-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2005-04-15	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040555-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2005-04-15	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040555-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2005-04-15	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040555-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2005-04-15	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040555-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2005-04-15	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040555-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL		2005-04-15	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040555-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL		2005-04-15	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040555-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL		2005-04-15	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040555-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL		2005-04-15	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040555-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL		2005-04-15	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040555-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL		2005-04-15	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040555-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL		2005-04-15	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040555-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL		2005-04-15	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040555-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL		2005-04-15	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040555-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL		2005-04-15	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040555-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL		2005-04-15	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040555-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL		2005-04-15	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A040555-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2005-04-15	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040555-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040555-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040555-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040555-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040555-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040555-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040555-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040555-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040555-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040555-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040555-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040555-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040555-001	AA	1	`ea99ee380514…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A040555-001	AA	1	`cb3db0bc1861…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
53002-7930-3	2020-12-17	C162847	48780-1	9d75b9d0-9bcb-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use PHENTERMINE HYDROCHLORIDE TABLETS, USP safely and effectively. See full prescribing information for PHENTERMINE HYDROCHLORIDE TABLETS, USP. PHENTERMINE HYDROCHLORIDE tablets, USP for oral use CIV Initial U.S. Approval: 1959
53002-7930-3	2020-01-31	C162847	48780-1	9d75b9d0-9bcb-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use PHENTERMINE HYDROCHLORIDE TABLETS, USP safely and effectively. See full prescribing information for PHENTERMINE HYDROCHLORIDE TABLETS, USP. PHENTERMINE HYDROCHLORIDE tablets, USP for oral use CIV Initial U.S. Approval: 1959

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
0K2I505OTV	PHENTERMINE HYDROCHLORIDE	1197-21-3	PHENTERMINE HYDROCHLORIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
53002-7930-3	53002793003	30 TABLET in 1 BOTTLE (53002-7930-3)	30 tablet	2017-10-01	0000-00-00	No	No	Current