Phentermine Hydrochloride

Product NDC: 84053-025
Requested package NDC: 84053-025-28
11-digit product format: 840530025
Labeler code: 84053
Product ID: 84053-025_3a9b5a93-de52-2dd1-e063-6394a90a311d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Phentermine Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Martek Pharmacal Co.
Application: ANDA040876
Marketing category: ANDA
Marketing start: 2024-02-01
Substance: PHENTERMINE HYDROCHLORIDE
Active strength: 37.5 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: 2026-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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 · 43 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
2026-09-14 22:38:34	2026-08	A040876-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2008-03-31	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A040876-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2008-03-31	`caaa826d4ba7…`
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…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A040876-001	AA	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A040876-001	AA	1	`caaa826d4ba7…`
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…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: Phentermine Hydrochloride
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
PHENTERMINE HYDROCHLORIDE	37.5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
0K2I505OTV	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
803353	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
c4e9ec2e-4660-4442-93d7-c05a16e137b5	Available on FDA.report

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
84053-025-07	Phentermine Hydrochloride	7 in 1 BOTTLE	TABLET	7	5
84053-025-14	Phentermine Hydrochloride	14 in 1 BOTTLE	TABLET	14	5
84053-025-28	Phentermine Hydrochloride	28 in 1 BOTTLE	TABLET	28	5
84053-025-56	Phentermine Hydrochloride	56 in 1 BOTTLE	TABLET	56	5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
84053-025	PHENTERMINE HYDROCHLORIDE TABLET [MARTEK PHARMACAL CO.]	2	Current NDC, 4 package rows	20240209_c4e9ec2e-4660-4442-93d7-c05a16e137b5.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 ndc (package): 84053-025-28 ndc (product): 84053-025 ndc11 (package): 84053002528
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	c4e9ec2e-4660-4442-93d7-c05a16e137b5	5
803353	phentermine hydrochloride 37.5 MG Oral Tablet	SCD	c4e9ec2e-4660-4442-93d7-c05a16e137b5	5
803353	phentermine hydrochloride 37.5 MG (equivalent to phentermine 30 MG) Oral Tablet	SY	c4e9ec2e-4660-4442-93d7-c05a16e137b5	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
84053-025-28	84053002528	28 TABLET in 1 BOTTLE (84053-025-28)	28 tablet	2024-02-01	No	No	Current