Phentermine Hydrochloride

Product NDC: 50436-3176
11-digit product format: 504363176
Labeler code: 50436
Product ID: 50436-3176_18723264-f933-49a2-ae5e-cfb576ec15bb
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Phentermine Hydrochloride
Dosage form: CAPSULE
Route: ORAL
Labeler: Unit Dose Services
Application: ANDA087022
Marketing category: ANDA
Marketing start: 2007-12-01
Marketing end: 0000-00-00
Substance: PHENTERMINE HYDROCHLORIDE
Active strength: 30 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: 2020-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	50436-3176		I	Inactivated by FDA		2026-08-07
excluded package	package	50436-3176	50436-3176-1	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 1 · 38 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	50436-3176-1	`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	50436-3176-1	`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	50436-3176-1	`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	50436-3176-1	`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	50436-3176-1	`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	50436-3176-1	`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	50436-3176-1	`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	50436-3176-1	`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	50436-3176-1	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	50436-3176-1	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	50436-3176-1	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	50436-3176-1	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	50436-3176-1	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	50436-3176-1	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	50436-3176-1	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	50436-3176-1	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	50436-3176-1	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	50436-3176-1	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	50436-3176-1	`8dfbde2a14a4…`	`c9ff85d89658…`

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A087022-001	PHENTERMINE HYDROCHLORIDE	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL			1983-02-03
A087022-002	PHENTERMINE HYDROCHLORIDE	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL			2012-01-20

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 3 · 82 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	A087022-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL		1983-02-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A087022-002	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL		2012-01-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A087022-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL		1983-02-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A087022-002	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL		2012-01-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A087022-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL		1983-02-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A087022-002	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL		2012-01-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A087022-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL		1983-02-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A087022-002	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL		2012-01-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A087022-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL		1983-02-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A087022-002	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL		2012-01-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A087022-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL		1983-02-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A087022-002	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL		2012-01-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A087022-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL		1983-02-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A087022-002	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL		2012-01-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A087022-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL		1983-02-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A087022-002	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL		2012-01-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A087022-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL		1983-02-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A087022-002	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL		2012-01-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A087022-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL		1983-02-03	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A087022-002	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL		2012-01-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A087022-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL		1983-02-03	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A087022-002	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL		2012-01-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A087022-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL		1983-02-03	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A087022-002	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL		2012-01-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A087022-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL		1983-02-03	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A087022-002	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL		2012-01-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A087022-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL		1983-02-03	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A087022-002	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL		2012-01-20	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A087022-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	1983-02-03	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A087022-002	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL	AA	2012-01-20	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A087022-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	1983-02-03	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A087022-002	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL	AA	2012-01-20	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A087022-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	1983-02-03	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A087022-002	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL	AA	2012-01-20	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A087022-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	1983-02-03	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A087022-002	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL	AA	2012-01-20	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A087022-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	1983-02-03	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A087022-002	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL	AA	2012-01-20	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A087022-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	1983-02-03	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A087022-002	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL	AA	2012-01-20	`782e0a99824c…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A087022-001	AA	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A087022-002	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A087022-001	AA	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A087022-002	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A087022-001	AA	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A087022-002	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A087022-001	AA	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A087022-002	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A087022-001	AA	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A087022-002	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A087022-001	AA	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A087022-002	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A087022-001	AA	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A087022-002	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A087022-001	AA	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A087022-002	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A087022-001	AA	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A087022-002	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A087022-001	AA	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A087022-002	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A087022-001	AA	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A087022-002	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A087022-001	AA	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A087022-002	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A087022-001	AA	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A087022-002	AA	1	`ea99ee380514…`
2023-01-26 05:58 UTC	2023-01	A087022-001	AA	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A087022-002	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A087022-001	AA	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A087022-002	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A087022-001	AA	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A087022-002	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A087022-001	AA	1	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A087022-002	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A087022-001	AA	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A087022-002	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, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
50436-3176-1	2021-01-29	C162847	48780-1	ba0f9c33-2cb8-a910-e053-dadaa90a0b85	These highlights do not include all the information needed to use phentermine hydrochloride capsules, USP safely and effectively. See full prescribing information for phentermine hydrochloride capsules, USP. PHENTERMINE Hydrochloride Capsules, USP for oral use CIV Initial U.S. Approval: 1959

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
50436-3176-1	Phentermine Hydrochloride	21 in 1 BOTTLE	CAPSULE	21		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50436-3176	PHENTERMINE HYDROCHLORIDE CAPSULE [UNIT DOSE SERVICES]	4	Legacy NDC, 1 package rows	20170926_a56c3aa5-ca6f-4c14-ab07-fbb3f8be060c.zip

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
900038	phentermine HCl 30 MG Oral Capsule	PSN	a56c3aa5-ca6f-4c14-ab07-fbb3f8be060c	4
900038	phentermine hydrochloride 30 MG Oral Capsule	SCD	a56c3aa5-ca6f-4c14-ab07-fbb3f8be060c	4
900038	phentermine hydrochloride 30 MG (equivalent to phentermine 24 MG) Oral Capsule	SY	a56c3aa5-ca6f-4c14-ab07-fbb3f8be060c	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
50436-3176-1	50436317601	21 in 1 BOTTLE	Historical