Phentermine hydrochloride

Product NDC: 53002-7931
Requested package NDC: 53002-7931-3
11-digit product format: 530027931
Labeler code: 53002
Product ID: 53002-7931_acf1ff22-a4bd-4a06-af3b-a27835acd07d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: phentermine hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: RPK Pharmaceuticals, Inc.
Application: ANDA205008
Marketing category: ANDA
Marketing start: 2017-01-24
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	53002-7931	53002-7931-3	D	Discontinued by firm		2026-08-03

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
A205008-001	PHENTERMINE HYDROCHLORIDE	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA		2014-09-25

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
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.

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	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#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
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…`

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
Effective	Related label
2023-06-07	These highlights do not include all the information needed to use Phentermine Hydrochloride Tablets and Capsules, USP 37.5 mg safely and effectively. See full prescribing information for Phentermine Hydrochloride Tablets and Capsules, USP 37.5 mg. PHENTERMINE hydrochloride capsules USP, for oral use CIV PHENTERMINE hydrochloride tablets USP, for oral use CIV Initial U.S. Approval: 1959
2023-01-30	These highlights do not include all the information needed to use Phentermine Hydrochloride Tablets and Capsules, USP 37.5 mg safely and effectively. See full prescribing information for Phentermine Hydrochloride Tablets and Capsules, USP 37.5 mg. PHENTERMINE hydrochloride capsules USP, for oral use CIV PHENTERMINE hydrochloride tablets USP, for oral use CIV Initial U.S. Approval: 1959
2020-12-17	These highlights do not include all the information needed to use Phentermine Hydrochloride Tablets and Capsules, USP 37.5 mg safely and effectively. See full prescribing information for Phentermine Hydrochloride Tablets and Capsules, USP 37.5 mg. PHENTERMINE hydrochloride capsules USP, for oral use CIV PHENTERMINE hydrochloride tablets USP, for oral use CIV Initial U.S. Approval: 1959
2020-01-31	These highlights do not include all the information needed to use Phentermine Hydrochloride Tablets and Capsules, USP 37.5 mg safely and effectively. See full prescribing information for Phentermine Hydrochloride Tablets and Capsules, USP 37.5 mg. PHENTERMINE hydrochloride capsules USP, for oral use CIV PHENTERMINE hydrochloride tablets USP, for oral use CIV Initial U.S. Approval: 1959

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.

Matched openFDA labels page 1 of 1 · 11 matching rows.

Brand, Generic, Manufacturer table
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	Exact identifier application applno (ANDA): 205008 application number: ANDA205008
Phentermine hydrochloride	PHENTERMINE HYDROCHLORIDE	Bryant Ranch Prepack	9155edf8-ea1d-458f-b2a7-e0303fd83cc0	2026-03-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205008 application number: ANDA205008
Phentermine hydrochloride	PHENTERMINE HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	129e781c-5366-4986-8e67-6b35fa4c3f39	2025-09-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205008 application number: ANDA205008
Phentermine hydrochloride	PHENTERMINE HYDROCHLORIDE	Bryant Ranch Prepack	e08b4f49-de9f-490d-b11d-d865439f5fad	2025-01-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205008 application number: ANDA205008
Phentermine hydrochloride	PHENTERMINE HYDROCHLORIDE	Bryant Ranch Prepack	e0a6a289-7dbf-4b24-b815-46dee0d19fdc	2025-01-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205008 application number: ANDA205008
Phentermine hydrochloride	PHENTERMINE HYDROCHLORIDE	Bryant Ranch Prepack	99c1325b-7152-481d-8a1f-6bf3e2c4808b	2025-01-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205008 application number: ANDA205008
Phentermine hydrochloride	PHENTERMINE HYDROCHLORIDE	SUNRISE PHARMACEUTICAL, INC.	43024f64-2d77-49a9-80fd-ad07a86c69a3	2024-12-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205008 application number: ANDA205008
Phentermine hydrochloride	PHENTERMINE HYDROCHLORIDE	Bryant Ranch Prepack	50efa498-11c5-41fa-95ac-419fcc10da03	2024-11-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205008 application number: ANDA205008
Phentermine hydrochloride	PHENTERMINE HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	1fa8798d-c096-5839-e063-6394a90aa28b	2024-09-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205008 application number: ANDA205008
Phentermine hydrochloride	PHENTERMINE HYDROCHLORIDE	Proficient Rx LP	28fda2ce-d445-47ce-8764-bf113b5db5b3	2022-11-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205008 application number: ANDA205008
Phentermine hydrochloride	PHENTERMINE HYDROCHLORIDE	Asclemed USA, Inc.	de76ed27-ac43-4923-b73f-461d33941f6b	2020-10-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205008 application number: ANDA205008

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
53002-7931-3	53002793103	30 TABLET in 1 BOTTLE (53002-7931-3)	30 tablet	2018-10-01	0000-00-00	No	No	Current