Phentermine Hydrochloride

Product NDC: 63629-5075
Requested package NDC: 63629-5075-1
11-digit product format: 636295075
Labeler code: 63629
Product ID: 63629-5075_3ab4628c-286b-45b7-b827-4eb633d5c434
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Phentermine Hydrochloride
Dosage form: CAPSULE
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA091359
Marketing category: ANDA
Marketing start: 2010-07-19
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: 2021-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

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

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	63629-5075	63629-5075-1	D	Discontinued by firm		2026-08-07

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 13 matching rows.

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

Captured / source date, Code, Status table
Captured / source date	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2019-12-08 06:16 UTC · source 2019-12-05	I	Inactivated by FDA	`110d247fa046…`	`a55b01930146…`

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
A091359-001	PHENTERMINE HYDROCHLORIDE	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL			2010-07-16

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	A091359-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL		2010-07-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091359-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL		2010-07-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091359-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL		2010-07-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091359-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL		2010-07-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091359-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL		2010-07-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091359-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL		2010-07-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091359-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL		2010-07-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091359-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL		2010-07-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091359-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL		2010-07-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091359-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL		2010-07-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091359-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL		2010-07-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091359-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL		2010-07-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091359-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL		2010-07-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091359-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL		2010-07-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091359-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL		2010-07-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091359-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL		2010-07-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091359-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL		2010-07-16	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091359-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL		2010-07-16	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091359-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL		2010-07-16	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091359-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL		2010-07-16	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091359-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL		2010-07-16	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A091359-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL		2010-07-16	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A091359-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL		2010-07-16	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A091359-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL		2010-07-16	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A091359-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL		2010-07-16	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A091359-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	2010-07-16	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A091359-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	2010-07-16	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A091359-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL		2010-07-16	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A091359-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL		2010-07-16	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A091359-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL		2010-07-16	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A091359-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL		2010-07-16	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A091359-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL		2010-07-16	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A091359-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL		2010-07-16	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A091359-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL		2010-07-16	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A091359-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL		2010-07-16	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A091359-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL		2010-07-16	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A091359-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL		2010-07-16	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A091359-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL		2010-07-16	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A091359-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL		2010-07-16	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A091359-001	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL		2010-07-16	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-09-15 20:21 UTC	2019-09	A091359-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A091359-001	AA	1	`ea99ee380514…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
63629-5075-1	2020-05-22	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
63629-5075-2	2020-05-22	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
63629-5075-3	2020-05-22	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
63629-5075-1	2019-11-27	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
63629-5075-2	2019-11-27	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
63629-5075-3	2019-11-27	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 Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
PHENTERMINE HYDROCHLORIDE	ACTIVE INGREDIENT	0K2I505OTV	PHENTERMINE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]	1000
PHENTERMINE	ACTIVE MOIETY	C045TQL4WP	PHENTERMINE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]	1000
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	PHENTERMINE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]	1000
ALUMINUM OXIDE	INACTIVE INGREDIENT	LMI26O6933	PHENTERMINE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]	1000
BUTYL ALCOHOL	INACTIVE INGREDIENT	8PJ61P6TS3	PHENTERMINE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]	1000
D&C RED NO. 28	INACTIVE INGREDIENT	767IP0Y5NH	PHENTERMINE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]	1000
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	PHENTERMINE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]	1000
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	PHENTERMINE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]	1000
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	PHENTERMINE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]	1000
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	PHENTERMINE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]	1000
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	PHENTERMINE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]	1000
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	PHENTERMINE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]	1000
GELATIN	INACTIVE INGREDIENT	2G86QN327L	PHENTERMINE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]	1000
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	PHENTERMINE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]	1000
METHYL ALCOHOL	INACTIVE INGREDIENT	Y4S76JWI15	PHENTERMINE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]	1000
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	PHENTERMINE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]	1000
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	PHENTERMINE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]	1000
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	PHENTERMINE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]	1000
SHELLAC	INACTIVE INGREDIENT	46N107B71O	PHENTERMINE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]	1000
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	PHENTERMINE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]	1000
SUCROSE	INACTIVE INGREDIENT	C151H8M554	PHENTERMINE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]	1000
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	PHENTERMINE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]	1000

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63629-5075-1	63629507501	30 CAPSULE in 1 BOTTLE (63629-5075-1)	30 capsule	2013-10-18	0000-00-00	No	No	Current