Phentermine Hydrochloride

Product NDC: 50436-0250
11-digit product format: 504360250
Labeler code: 50436
Product ID: 50436-0250_c02d1dab-aa1e-403d-8eec-e49871e3b77b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Phentermine Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Unit Dose Services
Application: ANDA040876
Marketing category: ANDA
Marketing start: 2012-08-15
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: 2022-12-31
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 · 8 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	50436-0250		I	Inactivated by FDA	2026-08-07
excluded package	package	50436-0250	50436-0250-1	I	Inactivated by FDA	2026-08-07
excluded package	package	50436-0250	50436-0250-2	I	Inactivated by FDA	2026-08-07
excluded package	package	50436-0250	50436-0250-3	I	Inactivated by FDA	2026-08-07
excluded package	package	50436-0250	50436-0250-4	I	Inactivated by FDA	2026-08-07
excluded package	package	50436-0250	50436-0250-5	I	Inactivated by FDA	2026-08-07
excluded package	package	50436-0250	50436-0250-6	I	Inactivated by FDA	2026-08-07
excluded package	package	50436-0250	50436-0250-7	I	Inactivated by FDA	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 2 · 88 matching rows.

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

Captured / source date, Dataset, Scope table
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	50436-0250-4	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	50436-0250-1	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	50436-0250-3	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	50436-0250-5	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	50436-0250-7	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	50436-0250-2	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	50436-0250-6	`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	50436-0250-4	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	50436-0250-1	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	50436-0250-3	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	50436-0250-5	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	50436-0250-7	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	50436-0250-2	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	50436-0250-6	`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	50436-0250-4	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	50436-0250-1	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	50436-0250-3	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	50436-0250-5	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	50436-0250-7	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	50436-0250-2	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	50436-0250-6	`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	50436-0250-4	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	50436-0250-1	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	50436-0250-3	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	50436-0250-5	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	50436-0250-7	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	50436-0250-2	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	50436-0250-6	`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	50436-0250-4	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	50436-0250-1	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	50436-0250-3	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	50436-0250-5	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	50436-0250-7	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	50436-0250-2	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	50436-0250-6	`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	50436-0250-4	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	50436-0250-1	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	50436-0250-3	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	50436-0250-5	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	50436-0250-7	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	50436-0250-2	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	50436-0250-6	`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	50436-0250-4	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	50436-0250-1	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	50436-0250-3	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	50436-0250-5	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	50436-0250-7	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	50436-0250-2	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	50436-0250-6	`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	50436-0250-4	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	50436-0250-1	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	50436-0250-3	`ed331223b511…`	`672a5bd82f5f…`

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
A040876-001	PHENTERMINE HYDROCHLORIDE	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA		2008-03-31

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A040876-001	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	A040876-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2008-03-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040876-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2008-03-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040876-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2008-03-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040876-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2008-03-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040876-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2008-03-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040876-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2008-03-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040876-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2008-03-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040876-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2008-03-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040876-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2008-03-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040876-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2008-03-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040876-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2008-03-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040876-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2008-03-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040876-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2008-03-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040876-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2008-03-31	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040876-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2008-03-31	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040876-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2008-03-31	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040876-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2008-03-31	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040876-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2008-03-31	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040876-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2008-03-31	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040876-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2008-03-31	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040876-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2008-03-31	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040876-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2008-03-31	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040876-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2008-03-31	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040876-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2008-03-31	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040876-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2008-03-31	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040876-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2008-03-31	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040876-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2008-03-31	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040876-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2008-03-31	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040876-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2008-03-31	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040876-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2008-03-31	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040876-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2008-03-31	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040876-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2008-03-31	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040876-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2008-03-31	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040876-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2008-03-31	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040876-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2008-03-31	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040876-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2008-03-31	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040876-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2008-03-31	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040876-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2008-03-31	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040876-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2008-03-31	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A040876-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2008-03-31	`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	A040876-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040876-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040876-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040876-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040876-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040876-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040876-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040876-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040876-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040876-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040876-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040876-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040876-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040876-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040876-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040876-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040876-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040876-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040876-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040876-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040876-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040876-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040876-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040876-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040876-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040876-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040876-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040876-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040876-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040876-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040876-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040876-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040876-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040876-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040876-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040876-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040876-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040876-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040876-001	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A040876-001	AA	1	`cb3db0bc1861…`

DailyMed Product Concepts#

Product concept, Relation, Version table
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#

NDC, Effective, Related label table
NDC	Effective	Related label
50436-0250-1	2024-07-30	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 Tablets and Capsules, USP 37.5 mg (phentermine hydrochloride, USP) CIV for oral use Initial U.S. Approval: 1959
50436-0250-2	2024-07-30	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 Tablets and Capsules, USP 37.5 mg (phentermine hydrochloride, USP) CIV for oral use Initial U.S. Approval: 1959
50436-0250-3	2024-07-30	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 Tablets and Capsules, USP 37.5 mg (phentermine hydrochloride, USP) CIV for oral use Initial U.S. Approval: 1959
50436-0250-4	2024-07-30	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 Tablets and Capsules, USP 37.5 mg (phentermine hydrochloride, USP) CIV for oral use Initial U.S. Approval: 1959
50436-0250-5	2024-07-30	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 Tablets and Capsules, USP 37.5 mg (phentermine hydrochloride, USP) CIV for oral use Initial U.S. Approval: 1959
50436-0250-6	2024-07-30	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 Tablets and Capsules, USP 37.5 mg (phentermine hydrochloride, USP) CIV for oral use Initial U.S. Approval: 1959
50436-0250-7	2024-07-30	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 Tablets and Capsules, USP 37.5 mg (phentermine hydrochloride, USP) CIV for oral use Initial U.S. Approval: 1959
50436-0250-1	2024-01-30	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 Tablets and Capsules, USP 37.5 mg (phentermine hydrochloride, USP) CIV for oral use Initial U.S. Approval: 1959
50436-0250-2	2024-01-30	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 Tablets and Capsules, USP 37.5 mg (phentermine hydrochloride, USP) CIV for oral use Initial U.S. Approval: 1959
50436-0250-3	2024-01-30	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 Tablets and Capsules, USP 37.5 mg (phentermine hydrochloride, USP) CIV for oral use Initial U.S. Approval: 1959
50436-0250-4	2024-01-30	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 Tablets and Capsules, USP 37.5 mg (phentermine hydrochloride, USP) CIV for oral use Initial U.S. Approval: 1959
50436-0250-5	2024-01-30	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 Tablets and Capsules, USP 37.5 mg (phentermine hydrochloride, USP) CIV for oral use Initial U.S. Approval: 1959
50436-0250-6	2024-01-30	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 Tablets and Capsules, USP 37.5 mg (phentermine hydrochloride, USP) CIV for oral use Initial U.S. Approval: 1959
50436-0250-7	2024-01-30	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 Tablets and Capsules, USP 37.5 mg (phentermine hydrochloride, USP) CIV for oral use Initial U.S. Approval: 1959
50436-0250-1	2023-04-04	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 Tablets and Capsules, USP 37.5 mg (phentermine hydrochloride, USP) CIV for oral use Initial U.S. Approval: 1959
50436-0250-2	2023-04-04	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 Tablets and Capsules, USP 37.5 mg (phentermine hydrochloride, USP) CIV for oral use Initial U.S. Approval: 1959
50436-0250-3	2023-04-04	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 Tablets and Capsules, USP 37.5 mg (phentermine hydrochloride, USP) CIV for oral use Initial U.S. Approval: 1959
50436-0250-4	2023-04-04	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 Tablets and Capsules, USP 37.5 mg (phentermine hydrochloride, USP) CIV for oral use Initial U.S. Approval: 1959
50436-0250-5	2023-04-04	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 Tablets and Capsules, USP 37.5 mg (phentermine hydrochloride, USP) CIV for oral use Initial U.S. Approval: 1959
50436-0250-6	2023-04-04	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 Tablets and Capsules, USP 37.5 mg (phentermine hydrochloride, USP) CIV for oral use Initial U.S. Approval: 1959
50436-0250-1	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 Tablets and Capsules, USP 37.5 mg (phentermine hydrochloride, USP) CIV for oral use Initial U.S. Approval: 1959
50436-0250-2	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 Tablets and Capsules, USP 37.5 mg (phentermine hydrochloride, USP) CIV for oral use Initial U.S. Approval: 1959
50436-0250-3	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 Tablets and Capsules, USP 37.5 mg (phentermine hydrochloride, USP) CIV for oral use Initial U.S. Approval: 1959
50436-0250-4	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 Tablets and Capsules, USP 37.5 mg (phentermine hydrochloride, USP) CIV for oral use Initial U.S. Approval: 1959
50436-0250-5	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 Tablets and Capsules, USP 37.5 mg (phentermine hydrochloride, USP) CIV for oral use Initial U.S. Approval: 1959
50436-0250-6	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 Tablets and Capsules, USP 37.5 mg (phentermine hydrochloride, USP) CIV for oral use Initial U.S. Approval: 1959
50436-0250-1	2021-03-17	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 Tablets and Capsules, USP 37.5 mg (phentermine hydrochloride, USP) CIV for oral use Initial U.S. Approval: 1959
50436-0250-2	2021-03-17	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 Tablets and Capsules, USP 37.5 mg (phentermine hydrochloride, USP) CIV for oral use Initial U.S. Approval: 1959
50436-0250-3	2021-03-17	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 Tablets and Capsules, USP 37.5 mg (phentermine hydrochloride, USP) CIV for oral use Initial U.S. Approval: 1959
50436-0250-4	2021-03-17	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 Tablets and Capsules, USP 37.5 mg (phentermine hydrochloride, USP) CIV for oral use Initial U.S. Approval: 1959
50436-0250-1	2021-01-29	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 Tablets and Capsules, USP 37.5 mg (phentermine hydrochloride, USP) CIV for oral use Initial U.S. Approval: 1959
50436-0250-2	2021-01-29	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 Tablets and Capsules, USP 37.5 mg (phentermine hydrochloride, USP) CIV for oral use Initial U.S. Approval: 1959
50436-0250-3	2021-01-29	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 Tablets and Capsules, USP 37.5 mg (phentermine hydrochloride, USP) CIV for oral use Initial U.S. Approval: 1959
50436-0250-4	2021-01-29	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 Tablets and Capsules, USP 37.5 mg (phentermine hydrochloride, USP) CIV for oral use Initial U.S. Approval: 1959

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
50436-0250-1	Phentermine Hydrochloride	7 in 1 BOTTLE	TABLET	7	5
50436-0250-2	Phentermine Hydrochloride	14 in 1 BOTTLE	TABLET	14	5
50436-0250-3	Phentermine Hydrochloride	21 in 1 BOTTLE	TABLET	21	5
50436-0250-4	Phentermine Hydrochloride	28 in 1 BOTTLE	TABLET	28	5
50436-0250-5	Phentermine Hydrochloride	30 in 1 BOTTLE	TABLET	30	5
50436-0250-6	Phentermine Hydrochloride	60 in 1 BOTTLE	TABLET	60	5
50436-0250-7	Phentermine Hydrochloride	56 in 1 BOTTLE	TABLET	56	5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50436-0250-1	EA - Each	50436-0250	891319d0-f52a-4147-aae2-60daa17434c9	1	2017-09-11
50436-0250-2	EA - Each	50436-0250	412203a0-c827-4f7e-981c-96f0d2ae065d	1	2017-09-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50436-0250	PHENTERMINE HYDROCHLORIDE TABLET [UNIT DOSE SERVICES]	5	Legacy NDC, 7 package rows	20230406_92e46d41-e566-474e-bebc-be282113ed3b.zip

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 · 9 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	Northwind Health Company, LLC	5528d9f7-45ad-d323-e063-6394a90a3e09	2026-06-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040876 application number: ANDA040876
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	A-S Medication Solutions	86ec6b9d-2934-4bad-8a80-0b60e2f912f3	2026-01-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040876 application number: ANDA040876
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	68fcc228-5f06-4ece-94f3-59b5b33c3325	2025-10-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040876 application number: ANDA040876
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	Martek Pharmacal Co.	c4e9ec2e-4660-4442-93d7-c05a16e137b5	2025-07-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040876 application number: ANDA040876
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	315b8a94-b7cc-1b47-e063-6294a90a2d39	2025-03-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040876 application number: ANDA040876
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	Calvin Scott & Co., Inc.	2d7ddbc2-2afc-473e-a73b-b44ab9fcfaab	2025-02-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040876 application number: ANDA040876
PHENTERMINE HYDROCHLORIDE	PHENTERMINE HYDROCHLORIDE	DirectRx	d27d8379-aa3c-4688-e053-2995a90a44f6	2025-01-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040876 application number: ANDA040876
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	Bryant Ranch Prepack	2bd5487d-10da-4ae0-9105-273e1a5efdcb	2024-08-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040876 application number: ANDA040876
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	KVK-TECH, Inc.	3b44d104-a7d0-4366-9d42-63f784f3cb22	2024-02-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040876 application number: ANDA040876

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
803353	phentermine HCl 37.5 MG Oral Tablet	PSN	92e46d41-e566-474e-bebc-be282113ed3b	5
803353	phentermine hydrochloride 37.5 MG Oral Tablet	SCD	92e46d41-e566-474e-bebc-be282113ed3b	5
803353	phentermine hydrochloride 37.5 MG (equivalent to phentermine 30 MG) Oral Tablet	SY	92e46d41-e566-474e-bebc-be282113ed3b	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50436-0250-1	50436025001	7 TABLET in 1 BOTTLE (50436-0250-1)	7 tablet	2017-07-07	0000-00-00	No	No	Current
50436-0250-2	50436025002	14 TABLET in 1 BOTTLE (50436-0250-2)	14 tablet	2017-07-07	0000-00-00	No	No	Current
50436-0250-3	50436025003	21 TABLET in 1 BOTTLE (50436-0250-3)	21 tablet	2017-07-07	0000-00-00	No	No	Current
50436-0250-4	50436025004	28 TABLET in 1 BOTTLE (50436-0250-4)	28 tablet	2017-07-07	0000-00-00	No	No	Current
50436-0250-5	50436025005	30 TABLET in 1 BOTTLE (50436-0250-5)	30 tablet	2021-03-17	0000-00-00	No	No	Current
50436-0250-6	50436025006	60 TABLET in 1 BOTTLE (50436-0250-6)	60 tablet	2021-03-17	0000-00-00	No	No	Current
50436-0250-7	50436025007	56 in 1 BOTTLE						Historical