Phentermine Hydrochloride

Product NDC: 68788-7823
Requested package NDC: 68788-7823-3
11-digit product format: 687887823
Labeler code: 68788
Product ID: 68788-7823_b51c120a-4028-4804-b0a3-d64f3d81d8ef
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Phentermine Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Preferred Pharmaceuticals Inc.
Application: ANDA040876
Marketing category: ANDA
Marketing start: 2020-11-20
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: 2022-12-31
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	68788-7823	68788-7823-3	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 · 12 matching rows.

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

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

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
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 · 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	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…`
2022-09-29 23:25 UTC	2022-09	A040876-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2008-03-31	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A040876-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2008-03-31	`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	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…`
2022-09-29 23:25 UTC	2022-09	A040876-001	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A040876-001	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
68788-7823-1	EA - Each	68788-7823	15427ab1-2290-4734-9ef9-875b1a064996	1	2021-01-08
68788-7823-3	EA - Each	68788-7823	3b476b55-c5ce-4c61-a5f0-21480f62823a	1	2021-01-08
68788-7823-5	EA - Each	68788-7823	3ce04e24-6d21-44fc-9f54-c14d8c361fef	1	2021-01-08

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
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68788-7823-3	68788782303	30 TABLET in 1 BOTTLE (68788-7823-3)	30 tablet	2020-11-20	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Phentermine Hydrochloride	Preferred Pharmaceuticals Inc.	2021-08-30	HUMAN PRESCRIPTION DRUG LABEL	2