Phentermine Hydrochloride

Product NDC: 45865-556
11-digit product format: 458650556
Labeler code: 45865
Product ID: 45865-556_7d633912-6179-b99b-e053-2a91aa0af59a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Phentermine Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: medsource pharmaceuticals
Application: ANDA203068
Marketing category: ANDA
Marketing start: 2017-03-21
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: 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	45865-556		I	Inactivated by FDA		2026-08-17
excluded package	package	45865-556	45865-556-30	I	Inactivated by FDA		2026-08-17

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 · 18 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	45865-556-30	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	45865-556-30	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	45865-556-30	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	45865-556-30	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	45865-556-30	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	45865-556-30	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	45865-556-30	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	45865-556-30	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	45865-556-30	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A203068-001	PHENTERMINE HYDROCHLORIDE	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA		2014-08-06

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A203068-001	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 · 42 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
2026-08-18 06:07:40	2026-07	A203068-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2014-08-06	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203068-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2014-08-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203068-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2014-08-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203068-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2014-08-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203068-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2014-08-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203068-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2014-08-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203068-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2014-08-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203068-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2014-08-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203068-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2014-08-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203068-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2014-08-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203068-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2014-08-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203068-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2014-08-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203068-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2014-08-06	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203068-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2014-08-06	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203068-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2014-08-06	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203068-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2014-08-06	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203068-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2014-08-06	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203068-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2014-08-06	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203068-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2014-08-06	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203068-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2014-08-06	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203068-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2014-08-06	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A203068-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2014-08-06	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A203068-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2014-08-06	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A203068-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2014-08-06	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A203068-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2014-08-06	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A203068-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2014-08-06	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A203068-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2014-08-06	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A203068-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2014-08-06	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A203068-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2014-08-06	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A203068-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2014-08-06	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A203068-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2014-08-06	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A203068-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2014-08-06	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A203068-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2014-08-06	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A203068-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2014-08-06	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A203068-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2014-08-06	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A203068-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2014-08-06	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A203068-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2014-08-06	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A203068-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2014-08-06	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A203068-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2014-08-06	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A203068-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	2014-08-06	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A203068-001	AA	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203068-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203068-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203068-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203068-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203068-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203068-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203068-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203068-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203068-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203068-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203068-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203068-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203068-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203068-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203068-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203068-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203068-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203068-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203068-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203068-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A203068-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A203068-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A203068-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A203068-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A203068-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A203068-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A203068-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A203068-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A203068-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A203068-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A203068-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A203068-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A203068-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A203068-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A203068-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A203068-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A203068-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A203068-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A203068-001	AA	1	`e64feba35796…`

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
45865-556-30	2025-01-30	C162847	48780-1	2cef2736-a886-d83d-e063-dadaa90ab31f	These highlights do not include all the information needed to use Phentermine Hydrochloride Tablets USP safely and effectively. See full prescribing information for Phentermine Hydrochloride Tablets USP. PHENTERMINE Hydrochloride Tablets, USP CIV Initial U.S. Approval: 1959

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
45865-556-30	Phentermine Hydrochloride	30 in 1 BOTTLE	TABLET	30		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
45865-556	PHENTERMINE HYDROCHLORIDE TABLET [MEDSOURCE PHARMACEUTICALS]	1	Legacy NDC, 1 package rows	20181220_7d633912-6178-b99b-e053-2a91aa0af59a.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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
PHENTERMINE HYDROCHLORIDE	PHENTERMINE HYDROCHLORIDE	Aurolife Pharma LLC	5927e0f6-3de3-4885-a633-5b92003f6fe4	2026-06-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203068 application number: ANDA203068
PHENTERMINE HYDROCHLORIDE	PHENTERMINE HYDROCHLORIDE	DIRECT RX	c3dda0a4-b428-f3e7-e053-2995a90ad106	2025-01-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203068 application number: ANDA203068
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	Proficient Rx LP	b3c48b3c-fab7-4ea4-93b0-b108979e9da3	2022-04-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203068 application number: ANDA203068

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	7d633912-6178-b99b-e053-2a91aa0af59a	1
803353	phentermine hydrochloride 37.5 MG Oral Tablet	SCD	7d633912-6178-b99b-e053-2a91aa0af59a	1
803353	phentermine hydrochloride 37.5 MG (equivalent to phentermine 30 MG) Oral Tablet	SY	7d633912-6178-b99b-e053-2a91aa0af59a	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
45865-556-30	45865055630	30 TABLET in 1 BOTTLE (45865-556-30)	30 tablet	2018-06-01	0000-00-00	No	No	Current