Phentermine Hydrochloride

Product NDC: 53489-406
11-digit product format: 534890406
Labeler code: 53489
Product ID: 53489-406_a78158e1-7c6b-4104-912e-f0650abe3fa9
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Phentermine Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Mutual Pharmaceutical Company, Inc.
Application: ANDA040526
Marketing category: ANDA
Marketing start: 2003-10-23
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: E
Listing certified through: 2017-12-31
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 · 7 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	53489-406		I	Inactivated by FDA	2026-08-03
excluded package	package	53489-406	53489-406-01	I	Inactivated by FDA	2026-08-03
excluded package	package	53489-406	53489-406-03	I	Inactivated by FDA	2026-08-03
excluded package	package	53489-406	53489-406-05	I	Inactivated by FDA	2026-08-03
excluded package	package	53489-406	53489-406-06	I	Inactivated by FDA	2026-08-03
excluded package	package	53489-406	53489-406-07	I	Inactivated by FDA	2026-08-03
excluded package	package	53489-406	53489-406-10	I	Inactivated by FDA	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 3 · 154 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	53489-406-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	53489-406-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	53489-406-10	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	53489-406-06	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	53489-406-07	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	53489-406-03	`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	53489-406-05	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	53489-406-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	53489-406-10	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	53489-406-06	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	53489-406-07	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	53489-406-03	`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	53489-406-05	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	53489-406-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	53489-406-10	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	53489-406-06	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	53489-406-07	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	53489-406-03	`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	53489-406-05	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	53489-406-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	53489-406-10	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	53489-406-06	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	53489-406-07	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	53489-406-03	`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	53489-406-05	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	53489-406-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	53489-406-10	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	53489-406-06	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	53489-406-07	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	53489-406-03	`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	53489-406-05	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	53489-406-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	53489-406-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	53489-406-06	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	53489-406-07	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	53489-406-03	`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	53489-406-05	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	53489-406-01	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	53489-406-10	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	53489-406-06	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	53489-406-07	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	53489-406-03	`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	53489-406-05	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	53489-406-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	53489-406-10	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	53489-406-06	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	53489-406-07	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	53489-406-03	`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	53489-406-05	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	53489-406-01	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	53489-406-10	`0efc9e666f02…`	`f202fb6c5f17…`

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
A040526-001	PHENTERMINE HYDROCHLORIDE	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA		2003-10-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A040526-001	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	A040526-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2003-10-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040526-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2003-10-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040526-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2003-10-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040526-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2003-10-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040526-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2003-10-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040526-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2003-10-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040526-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2003-10-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040526-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2003-10-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040526-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2003-10-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040526-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2003-10-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040526-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2003-10-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040526-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2003-10-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040526-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2003-10-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040526-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2003-10-23	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040526-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2003-10-23	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040526-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2003-10-23	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040526-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2003-10-23	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040526-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2003-10-23	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040526-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2003-10-23	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040526-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2003-10-23	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040526-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2003-10-23	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040526-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2003-10-23	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040526-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2003-10-23	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040526-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2003-10-23	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040526-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2003-10-23	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040526-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2003-10-23	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040526-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2003-10-23	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040526-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2003-10-23	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040526-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2003-10-23	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040526-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2003-10-23	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040526-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2003-10-23	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040526-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2003-10-23	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040526-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2003-10-23	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040526-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2003-10-23	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040526-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2003-10-23	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040526-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2003-10-23	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040526-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2003-10-23	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040526-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2003-10-23	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040526-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2003-10-23	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A040526-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2003-10-23	`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	A040526-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040526-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040526-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040526-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040526-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040526-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040526-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040526-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040526-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040526-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040526-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040526-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040526-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040526-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040526-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040526-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040526-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040526-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040526-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040526-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040526-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040526-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040526-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040526-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040526-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040526-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040526-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040526-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040526-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040526-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040526-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040526-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040526-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040526-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040526-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040526-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040526-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040526-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040526-001	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A040526-001	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, Related label table
NDC	Related label
53489-406-01	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 CIV for oral use Initial U.S. Approval: 1959
53489-406-03	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 CIV for oral use Initial U.S. Approval: 1959
53489-406-05	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 CIV for oral use Initial U.S. Approval: 1959
53489-406-06	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 CIV for oral use Initial U.S. Approval: 1959
53489-406-07	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 CIV for oral use Initial U.S. Approval: 1959
53489-406-10	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 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
53489-406-01	Phentermine Hydrochloride	100 in 1 BOTTLE, PLASTIC	TABLET	100	5
53489-406-03	Phentermine Hydrochloride	250 in 1 BOTTLE, PLASTIC	TABLET	250	5
53489-406-05	Phentermine Hydrochloride	500 in 1 BOTTLE, PLASTIC	TABLET	500	5
53489-406-06	Phentermine Hydrochloride	60 in 1 BOTTLE, PLASTIC	TABLET	60	5
53489-406-07	Phentermine Hydrochloride	30 in 1 BOTTLE, PLASTIC	TABLET	30	5
53489-406-10	Phentermine Hydrochloride	1000 in 1 BOTTLE, PLASTIC	TABLET	1000	5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
53489-406-01	EA - Each	53489-406	750bcb95-1b21-4b60-9e9b-f04380cac5ec	1	2012-07-24
53489-406-10	EA - Each	53489-406	0c495180-3e04-4e5a-a2db-fbabc001f8fc	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Phentermine Hydrochloride	ACTIVE INGREDIENT	0K2I505OTV	PHENTERMINE HYDROCHLORIDE TABLET [MUTUAL PHARMACEUTICAL COMPANY, INC.]	5
Phentermine	ACTIVE MOIETY	C045TQL4WP	PHENTERMINE HYDROCHLORIDE TABLET [MUTUAL PHARMACEUTICAL COMPANY, INC.]	5
calcium phosphate, dibasic, dihydrate	INACTIVE INGREDIENT	O7TSZ97GEP	PHENTERMINE HYDROCHLORIDE TABLET [MUTUAL PHARMACEUTICAL COMPANY, INC.]	5
crospovidone	INACTIVE INGREDIENT	68401960MK	PHENTERMINE HYDROCHLORIDE TABLET [MUTUAL PHARMACEUTICAL COMPANY, INC.]	5
FD&C Blue No. 1	INACTIVE INGREDIENT	H3R47K3TBD	PHENTERMINE HYDROCHLORIDE TABLET [MUTUAL PHARMACEUTICAL COMPANY, INC.]	5
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	PHENTERMINE HYDROCHLORIDE TABLET [MUTUAL PHARMACEUTICAL COMPANY, INC.]	5
povidones	INACTIVE INGREDIENT	FZ989GH94E	PHENTERMINE HYDROCHLORIDE TABLET [MUTUAL PHARMACEUTICAL COMPANY, INC.]	5
propylene glycol	INACTIVE INGREDIENT	6DC9Q167V3	PHENTERMINE HYDROCHLORIDE TABLET [MUTUAL PHARMACEUTICAL COMPANY, INC.]	5
shellac	INACTIVE INGREDIENT	46N107B71O	PHENTERMINE HYDROCHLORIDE TABLET [MUTUAL PHARMACEUTICAL COMPANY, INC.]	5
titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	PHENTERMINE HYDROCHLORIDE TABLET [MUTUAL PHARMACEUTICAL COMPANY, INC.]	5
Phentermine Hydrochloride	ACTIVE INGREDIENT	0K2I505OTV	PHENTERMINE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]	3
Phentermine	ACTIVE MOIETY	C045TQL4WP	PHENTERMINE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]	3
povidone	INACTIVE INGREDIENT	FZ989GH94E	PHENTERMINE HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]	3
Phentermine Hydrochloride	ACTIVE INGREDIENT	0K2I505OTV	PHENTERMINE HYDROCHLORIDE TABLET [UNIT DOSE SERVICES]	2
PHENTERMINE HYDROCHLORIDE	ACTIVE INGREDIENT	0K2I505OTV	PHENTERMINE HYDROCHLORIDE TABLET [KELTMAN PHARMACEUTICALS INC.]	2
Phentermine Hydrochloride	ACTIVE INGREDIENT	0K2I505OTV	PHENTERMINE HYDROCHLORIDE TABLET [H.J. HARKINS COMPANY, INC.]	2
Phentermine Hydrochloride	ACTIVE INGREDIENT	0K2I505OTV	PHENTERMINE HYDROCHLORIDE TABLET [RXCHANGE CO.]	2
Phentermine	ACTIVE MOIETY	C045TQL4WP	PHENTERMINE HYDROCHLORIDE TABLET [H.J. HARKINS COMPANY, INC.]	2
Phentermine	ACTIVE MOIETY	C045TQL4WP	PHENTERMINE HYDROCHLORIDE TABLET [RXCHANGE CO.]	2
Phentermine	ACTIVE MOIETY	C045TQL4WP	PHENTERMINE HYDROCHLORIDE TABLET [UNIT DOSE SERVICES]	2
Phentermine	ACTIVE MOIETY	C045TQL4WP	PHENTERMINE HYDROCHLORIDE TABLET [KELTMAN PHARMACEUTICALS INC.]	2
calcium phosphate, dibasic, dihydrate	INACTIVE INGREDIENT	O7TSZ97GEP	PHENTERMINE HYDROCHLORIDE TABLET [RXCHANGE CO.]	2
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE	INACTIVE INGREDIENT	O7TSZ97GEP	PHENTERMINE HYDROCHLORIDE TABLET [UNIT DOSE SERVICES]	2
crospovidone	INACTIVE INGREDIENT	68401960MK	PHENTERMINE HYDROCHLORIDE TABLET [RXCHANGE CO.]	2
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	PHENTERMINE HYDROCHLORIDE TABLET [UNIT DOSE SERVICES]	2
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	PHENTERMINE HYDROCHLORIDE TABLET [UNIT DOSE SERVICES]	2
FD&C Blue No. 1	INACTIVE INGREDIENT	H3R47K3TBD	PHENTERMINE HYDROCHLORIDE TABLET [RXCHANGE CO.]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	PHENTERMINE HYDROCHLORIDE TABLET [UNIT DOSE SERVICES]	2
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	PHENTERMINE HYDROCHLORIDE TABLET [RXCHANGE CO.]	2
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	PHENTERMINE HYDROCHLORIDE TABLET [KELTMAN PHARMACEUTICALS INC.]	2
povidones	INACTIVE INGREDIENT	FZ989GH94E	PHENTERMINE HYDROCHLORIDE TABLET [RXCHANGE CO.]	2
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	PHENTERMINE HYDROCHLORIDE TABLET [UNIT DOSE SERVICES]	2
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	PHENTERMINE HYDROCHLORIDE TABLET [UNIT DOSE SERVICES]	2
propylene glycol	INACTIVE INGREDIENT	6DC9Q167V3	PHENTERMINE HYDROCHLORIDE TABLET [RXCHANGE CO.]	2
shellac	INACTIVE INGREDIENT	46N107B71O	PHENTERMINE HYDROCHLORIDE TABLET [RXCHANGE CO.]	2
SHELLAC	INACTIVE INGREDIENT	46N107B71O	PHENTERMINE HYDROCHLORIDE TABLET [UNIT DOSE SERVICES]	2
titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	PHENTERMINE HYDROCHLORIDE TABLET [RXCHANGE CO.]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	PHENTERMINE HYDROCHLORIDE TABLET [UNIT DOSE SERVICES]	2
PHENTERMINE HYDROCHLORIDE	ACTIVE INGREDIENT	0K2I505OTV	PHENTERMINE HYDROCHLORIDE TABLET PHENTERMINE HYDROCHLORIDE CAPSULE [APOTHECA, INC.]	1
Phentermine Hydrochloride	ACTIVE INGREDIENT	0K2I505OTV	PHENTERMINE HYDROCHLORIDE TABLET [STAT RX USA LLC]	1
Phentermine Hydrochloride	ACTIVE INGREDIENT	0K2I505OTV	PHENTERMINE HYDROCHLORIDE TABLET [DISPENSING SOLUTIONS, INC.]	1
Phentermine Hydrochloride	ACTIVE INGREDIENT	0K2I505OTV	PHENTERMINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP.]	1
Phentermine Hydrochloride	ACTIVE INGREDIENT	0K2I505OTV	PHENTERMINE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]	1
Phentermine	ACTIVE MOIETY	C045TQL4WP	PHENTERMINE HYDROCHLORIDE TABLET [DISPENSING SOLUTIONS, INC.]	1
PHENTERMINE	ACTIVE MOIETY	C045TQL4WP	PHENTERMINE HYDROCHLORIDE TABLET PHENTERMINE HYDROCHLORIDE CAPSULE [APOTHECA, INC.]	1
Phentermine	ACTIVE MOIETY	C045TQL4WP	PHENTERMINE HYDROCHLORIDE TABLET [STAT RX USA LLC]	1
Phentermine	ACTIVE MOIETY	C045TQL4WP	PHENTERMINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP.]	1
Phentermine	ACTIVE MOIETY	C045TQL4WP	PHENTERMINE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]	1
calcium phosphate, dibasic, dihydrate	INACTIVE INGREDIENT	O7TSZ97GEP	PHENTERMINE HYDROCHLORIDE TABLET [STAT RX USA LLC]	1
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	PHENTERMINE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]	1
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	PHENTERMINE HYDROCHLORIDE TABLET PHENTERMINE HYDROCHLORIDE CAPSULE [APOTHECA, INC.]	1
crospovidone	INACTIVE INGREDIENT	68401960MK	PHENTERMINE HYDROCHLORIDE TABLET [STAT RX USA LLC]	1
D&C RED NO. 33	INACTIVE INGREDIENT	9DBA0SBB0L	PHENTERMINE HYDROCHLORIDE TABLET PHENTERMINE HYDROCHLORIDE CAPSULE [APOTHECA, INC.]	1
DIBASIC CALCIUM PHOSPHATE DIHYDRATE	INACTIVE INGREDIENT	O7TSZ97GEP	PHENTERMINE HYDROCHLORIDE TABLET PHENTERMINE HYDROCHLORIDE CAPSULE [APOTHECA, INC.]	1
DIBASIC CALCIUM PHOSPHATE DIHYDRATE	INACTIVE INGREDIENT	O7TSZ97GEP	PHENTERMINE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	PHENTERMINE HYDROCHLORIDE TABLET PHENTERMINE HYDROCHLORIDE CAPSULE [APOTHECA, INC.]	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	PHENTERMINE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]	1
FD&C Blue No. 1	INACTIVE INGREDIENT	H3R47K3TBD	PHENTERMINE HYDROCHLORIDE TABLET [STAT RX USA LLC]	1
GELATIN	INACTIVE INGREDIENT	2G86QN327L	PHENTERMINE HYDROCHLORIDE TABLET PHENTERMINE HYDROCHLORIDE CAPSULE [APOTHECA, INC.]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	PHENTERMINE HYDROCHLORIDE TABLET PHENTERMINE HYDROCHLORIDE CAPSULE [APOTHECA, INC.]	1
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	PHENTERMINE HYDROCHLORIDE TABLET [STAT RX USA LLC]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	PHENTERMINE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	PHENTERMINE HYDROCHLORIDE TABLET PHENTERMINE HYDROCHLORIDE CAPSULE [APOTHECA, INC.]	1
povidone	INACTIVE INGREDIENT	FZ989GH94E	PHENTERMINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP.]	1
povidone	INACTIVE INGREDIENT	FZ989GH94E	PHENTERMINE HYDROCHLORIDE TABLET [STAT RX USA LLC]	1
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	PHENTERMINE HYDROCHLORIDE TABLET PHENTERMINE HYDROCHLORIDE CAPSULE [APOTHECA, INC.]	1
povidone	INACTIVE INGREDIENT	FZ989GH94E	PHENTERMINE HYDROCHLORIDE TABLET [DISPENSING SOLUTIONS, INC.]	1
povidone	INACTIVE INGREDIENT	FZ989GH94E	PHENTERMINE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	PHENTERMINE HYDROCHLORIDE TABLET PHENTERMINE HYDROCHLORIDE CAPSULE [APOTHECA, INC.]	1
propylene glycol	INACTIVE INGREDIENT	6DC9Q167V3	PHENTERMINE HYDROCHLORIDE TABLET [STAT RX USA LLC]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	PHENTERMINE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]	1
SHELLAC	INACTIVE INGREDIENT	46N107B71O	PHENTERMINE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]	1
shellac	INACTIVE INGREDIENT	46N107B71O	PHENTERMINE HYDROCHLORIDE TABLET [STAT RX USA LLC]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	PHENTERMINE HYDROCHLORIDE TABLET PHENTERMINE HYDROCHLORIDE CAPSULE [APOTHECA, INC.]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	PHENTERMINE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	PHENTERMINE HYDROCHLORIDE TABLET PHENTERMINE HYDROCHLORIDE CAPSULE [APOTHECA, INC.]	1
titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	PHENTERMINE HYDROCHLORIDE TABLET [STAT RX USA LLC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53489-406	PHENTERMINE HYDROCHLORIDE TABLET [MUTUAL PHARMACEUTICAL COMPANY, INC.]	5	Legacy NDC, 6 package rows	20121204_0ee5b71b-3d8e-46d0-937d-2dbe43490e33.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 · 16 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Phentermine HCL C-IV	PHENTERMINE HCL C-IV	Direct_Rx	4cec0e47-5373-2133-e063-6394a90a2009	2026-03-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040526 application number: ANDA040526
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	Calvin Scott & Co., Inc.	aa9d7161-cda3-4ded-8d5b-424abd1a6681	2026-02-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040526 application number: ANDA040526
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	A-S Medication Solutions	0e893b62-bb07-4984-9f0a-3601435fbc27	2026-01-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040526 application number: ANDA040526
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	Northwind Health Company, LLC	1b5396a8-e7ef-45ae-e063-6294a90a14a2	2025-12-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040526 application number: ANDA040526
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	abf702d6-6f94-48dc-ad23-c52fd74e83a8	2025-10-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040526 application number: ANDA040526
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	Martek Pharmacal Co.	12699287-9ca9-07b3-e063-6294a90af21a	2025-07-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040526 application number: ANDA040526
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	Sun Pharmaceutical Industries, Inc.	02b8f684-b1ca-4ab7-9567-bcacc6a92779	2025-07-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040526 application number: ANDA040526
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	312d9742-6a65-c1cb-e063-6394a90a2e66	2025-03-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040526 application number: ANDA040526
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	8abf898e-318b-3519-e053-2995a90abf2f	2024-09-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040526 application number: ANDA040526
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	Bryant Ranch Prepack	53cad049-f1b4-42c0-9cc7-a1c2df75ac58	2024-08-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040526 application number: ANDA040526
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	Bryant Ranch Prepack	0ca26b58-0a93-4a10-be4d-63a4ad5eecf8	2024-06-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040526 application number: ANDA040526
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	Bryant Ranch Prepack	ac8559a0-98fe-4737-b9ec-e36eef3b14fc	2024-04-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040526 application number: ANDA040526
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	Bryant Ranch Prepack	c5d60a6d-2410-4a3c-88e1-a6126b56cf6a	2024-04-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040526 application number: ANDA040526
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	Bryant Ranch Prepack	95f908c2-1003-4e8f-8e4a-86f493456878	2024-01-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040526 application number: ANDA040526
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	Bryant Ranch Prepack	83802088-f4fc-4b34-9268-d63fb2ad1655	2023-09-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040526 application number: ANDA040526
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	Proficient Rx LP	b14a8f6a-a1c6-4104-80f2-0fa35320d04c	2023-05-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040526 application number: ANDA040526

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	58462270-0b4d-455e-ae9d-d2e13d6cab3f	6
803353	phentermine hydrochloride 37.5 MG Oral Tablet	SCD	58462270-0b4d-455e-ae9d-d2e13d6cab3f	6
803353	phentermine hydrochloride 37.5 MG (equivalent to phentermine 30 MG) Oral Tablet	SY	58462270-0b4d-455e-ae9d-d2e13d6cab3f	6
803353	phentermine HCl 37.5 MG Oral Tablet	PSN	0ee5b71b-3d8e-46d0-937d-2dbe43490e33	5
803353	phentermine hydrochloride 37.5 MG Oral Tablet	SCD	0ee5b71b-3d8e-46d0-937d-2dbe43490e33	5
803353	phentermine hydrochloride 37.5 MG (equivalent to phentermine 30 MG) Oral Tablet	SY	0ee5b71b-3d8e-46d0-937d-2dbe43490e33	5
803353	phentermine HCl 37.5 MG Oral Tablet	PSN	027d77a3-6d62-498b-8901-86f1f73362d5	3
803353	phentermine HCl 37.5 MG Oral Tablet	PSN	a3600c42-470a-4a36-9e9a-d74504de8c40	3
803353	phentermine hydrochloride 37.5 MG Oral Tablet	SCD	027d77a3-6d62-498b-8901-86f1f73362d5	3
803353	phentermine hydrochloride 37.5 MG Oral Tablet	SCD	a3600c42-470a-4a36-9e9a-d74504de8c40	3
803353	phentermine hydrochloride 37.5 MG (equivalent to phentermine 30 MG) Oral Tablet	SY	027d77a3-6d62-498b-8901-86f1f73362d5	3
803353	phentermine hydrochloride 37.5 MG (equivalent to phentermine 30 MG) Oral Tablet	SY	a3600c42-470a-4a36-9e9a-d74504de8c40	3
803353	phentermine HCl 37.5 MG Oral Tablet	PSN	eed1670d-88a1-4edd-9de9-9eeb395970d7	2
803353	phentermine HCl 37.5 MG Oral Tablet	PSN	a894c87a-f04d-4080-a52b-b3fd8b8b6e01	2
803353	phentermine HCl 37.5 MG Oral Tablet	PSN	7a971256-645a-4477-86c7-5033e0e520f6	2
803353	phentermine hydrochloride 37.5 MG Oral Tablet	SCD	7a971256-645a-4477-86c7-5033e0e520f6	2
803353	phentermine hydrochloride 37.5 MG Oral Tablet	SCD	eed1670d-88a1-4edd-9de9-9eeb395970d7	2
803353	phentermine hydrochloride 37.5 MG Oral Tablet	SCD	a894c87a-f04d-4080-a52b-b3fd8b8b6e01	2
803353	phentermine hydrochloride 37.5 MG (equivalent to phentermine 30 MG) Oral Tablet	SY	eed1670d-88a1-4edd-9de9-9eeb395970d7	2
803353	phentermine hydrochloride 37.5 MG (equivalent to phentermine 30 MG) Oral Tablet	SY	7a971256-645a-4477-86c7-5033e0e520f6	2
803353	phentermine hydrochloride 37.5 MG (equivalent to phentermine 30 MG) Oral Tablet	SY	a894c87a-f04d-4080-a52b-b3fd8b8b6e01	2
803353	phentermine HCl 37.5 MG Oral Tablet	PSN	7fb51344-baa4-4905-8ee7-a2db973786fc	1
803353	phentermine HCl 37.5 MG Oral Tablet	PSN	554adcd6-8a4f-402a-8105-4e70f92e97ea	1
803353	phentermine HCl 37.5 MG Oral Tablet	PSN	d60075f0-19b9-410d-b93b-d897de08f5a5	1
803353	phentermine HCl 37.5 MG Oral Tablet	PSN	80d92084-99dd-4a13-bd63-772a6363a256	1
803353	phentermine hydrochloride 37.5 MG Oral Tablet	SCD	554adcd6-8a4f-402a-8105-4e70f92e97ea	1
803353	phentermine hydrochloride 37.5 MG Oral Tablet	SCD	80d92084-99dd-4a13-bd63-772a6363a256	1
803353	phentermine hydrochloride 37.5 MG Oral Tablet	SCD	d60075f0-19b9-410d-b93b-d897de08f5a5	1
803353	phentermine hydrochloride 37.5 MG Oral Tablet	SCD	7fb51344-baa4-4905-8ee7-a2db973786fc	1
803353	phentermine hydrochloride 37.5 MG (equivalent to phentermine 30 MG) Oral Tablet	SY	554adcd6-8a4f-402a-8105-4e70f92e97ea	1
803353	phentermine hydrochloride 37.5 MG (equivalent to phentermine 30 MG) Oral Tablet	SY	80d92084-99dd-4a13-bd63-772a6363a256	1
803353	phentermine hydrochloride 37.5 MG (equivalent to phentermine 30 MG) Oral Tablet	SY	d60075f0-19b9-410d-b93b-d897de08f5a5	1
803353	phentermine hydrochloride 37.5 MG (equivalent to phentermine 30 MG) Oral Tablet	SY	7fb51344-baa4-4905-8ee7-a2db973786fc	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
53489-406-01	53489040601	100 in 1 BOTTLE, PLASTIC	Historical
53489-406-03	53489040603	250 in 1 BOTTLE, PLASTIC	Historical
53489-406-05	53489040605	500 in 1 BOTTLE, PLASTIC	Historical
53489-406-06	53489040606	60 in 1 BOTTLE, PLASTIC	Historical
53489-406-07	53489040607	30 in 1 BOTTLE, PLASTIC	Historical
53489-406-10	53489040610	1000 in 1 BOTTLE, PLASTIC	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Phentermine Hydrochloride	Unit Dose Services	2019-05-08	HUMAN PRESCRIPTION DRUG LABEL	6
Phentermine Hydrochloride	Apotheca Inc.	2016-06-29	HUMAN PRESCRIPTION DRUG LABEL	3
Phentermine Hydrochloride	RxChange Co.	2014-12-10	HUMAN PRESCRIPTION DRUG LABEL	2
Phentermine Hydrochloride	Mutual Pharmaceutical Company, Inc.	2012-10-23	HUMAN PRESCRIPTION DRUG LABEL	5
Phentermine Hydrochloride	STAT Rx USA LLC \| PSS World Medical Inc.	2012-08-06	HUMAN PRESCRIPTION DRUG LABEL	1
PHENTERMINE HYDROCHLORIDE TABLETS USP, 37.5 mg CIV	Dispensing Solutions, Inc. \| PSS World Medical, Inc.	2012-02-09	HUMAN PRESCRIPTION DRUG LABEL	1
PHENTERMINE HYDROCHLORIDE TABLETS USP, 37.5 mg CIV	H.J. Harkins Company, Inc. \| Mutual Pharmaceutical	2011-12-29	HUMAN PRESCRIPTION DRUG LABEL	2
PHENTERMINE HYDROCHLORIDE TABLETS USP, 37.5 mg CIV	Blenheim Pharmacal, Inc.	2010-09-10	HUMAN PRESCRIPTION DRUG LABEL	3
PHENTERMINE HYDROCHLORIDE TABLETS USP, 37.5 mg CIV	Keltman Pharmaceuticals Inc. \| Sandhills Packaging	2010-06-23	HUMAN PRESCRIPTION DRUG LABEL	2
PHENTERMINE HYDROCHLORIDE TABLETS USP, 37.5 mg CIV	Rebel Distributors Corp.	2009-12-15	HUMAN PRESCRIPTION DRUG LABEL	1
PHENTERMINE HYDROCHLORIDE TABLETS USP, 37.5 mg CIV	Physicians Total Care, Inc.	2009-12-14	HUMAN PRESCRIPTION DRUG LABEL	1