Phentermine Hydrochloride

Product NDC: 63629-1044
11-digit product format: 636291044
Labeler code: 63629
Product ID: 63629-1044_2b36999f-c5d5-48f6-bda2-fe8b4fa420f2
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Phentermine Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA200272
Marketing category: ANDA
Marketing start: 2011-03-08
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: 2023-12-31
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	63629-1044		D	Discontinued by firm		2026-08-10
excluded package	package	63629-1044	63629-1044-1	D	Discontinued by firm		2026-08-10

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
A200272-001	PHENTERMINE HYDROCHLORIDE	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA		2011-01-31

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A200272-001	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	A200272-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2011-01-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200272-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2011-01-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A200272-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2011-01-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200272-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2011-01-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200272-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2011-01-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200272-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2011-01-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200272-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2011-01-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200272-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2011-01-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200272-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2011-01-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A200272-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2011-01-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200272-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2011-01-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200272-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2011-01-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200272-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2011-01-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A200272-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2011-01-31	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A200272-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2011-01-31	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A200272-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2011-01-31	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A200272-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2011-01-31	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A200272-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2011-01-31	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A200272-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2011-01-31	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A200272-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2011-01-31	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A200272-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2011-01-31	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A200272-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2011-01-31	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A200272-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2011-01-31	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A200272-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2011-01-31	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A200272-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2011-01-31	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A200272-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2011-01-31	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A200272-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2011-01-31	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A200272-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2011-01-31	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A200272-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2011-01-31	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A200272-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2011-01-31	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A200272-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2011-01-31	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A200272-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2011-01-31	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A200272-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2011-01-31	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A200272-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2011-01-31	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A200272-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2011-01-31	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A200272-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2011-01-31	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A200272-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2011-01-31	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A200272-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2011-01-31	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A200272-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2011-01-31	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A200272-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2011-01-31	`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	A200272-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200272-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A200272-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200272-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200272-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200272-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200272-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200272-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200272-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A200272-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200272-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200272-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200272-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A200272-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A200272-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A200272-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A200272-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A200272-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A200272-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A200272-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A200272-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A200272-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A200272-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A200272-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A200272-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A200272-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A200272-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A200272-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A200272-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A200272-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A200272-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A200272-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A200272-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A200272-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A200272-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A200272-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A200272-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A200272-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A200272-001	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A200272-001	AA	1	`cb3db0bc1861…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63629-1044-1	EA - Each	63629-1044	6574ad6f-3bd9-49ca-a18e-2e04ec5bd304	1	2019-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63629-1044	PHENTERMINE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]	7	Legacy NDC	20230519_7e370e9c-b8ab-4313-85d6-2f3ccd22f7ff.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 · 10 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	19f1ce79-65f4-4bf4-a9ff-6ca0a131530f	2026-06-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200272 application number: ANDA200272
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	Bryant Ranch Prepack	e6939fcf-3db2-492a-99ed-a384cdeea7a2	2026-05-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200272 application number: ANDA200272
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	Bryant Ranch Prepack	328d6a39-34f4-4b74-a1bf-6ec6005b1322	2026-04-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200272 application number: ANDA200272
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	TAGI Pharma, Inc.	1993b181-f4f1-4451-92a0-7ed8f32598ba	2025-12-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200272 application number: ANDA200272
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	Precision Dose Inc.	8d5697b9-02e8-40c4-97c7-761d635243c8	2025-12-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200272 application number: ANDA200272
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	Calvin Scott & Co., Inc.	f3b43443-dcf3-4a0d-a919-1be1bb9495ed	2025-04-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200272 application number: ANDA200272
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	30b48126-45f3-21fa-e063-6294a90a968f	2025-03-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200272 application number: ANDA200272
Phentermine HCL	PHENTERMINE HYDROCHLORIDE	Calvin Scott & Co., Inc.	8fe6b65d-ca61-40f0-90fc-255dfd075611	2024-10-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200272 application number: ANDA200272
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	Bryant Ranch Prepack	bd7393cb-2b72-4ecd-ba03-801b635b7647	2024-08-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200272 application number: ANDA200272
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	Bryant Ranch Prepack	707af68e-1630-4f86-87ba-1a643d2b4ef9	2023-10-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200272 application number: ANDA200272

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
63629-1044-1	63629104401	100 TABLET in 1 BOTTLE (63629-1044-1)	100 tablet	2019-07-01	0000-00-00	No	No	Current