Phentermine Hydrochloride

Product NDC: 42806-810
11-digit product format: 428060810
Labeler code: 42806
Product ID: 42806-810_c05e4350-a70c-41d0-ac28-30b47133b0b8
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Phentermine Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Epic Pharma, LLC
Application: ANDA040190
Marketing category: ANDA
Marketing start: 2014-05-01
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: 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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	42806-810		D	Discontinued by firm	2026-08-07
excluded package	package	42806-810	42806-810-01	D	Discontinued by firm	2026-08-07
excluded package	package	42806-810	42806-810-10	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 · 3 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Archive	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product	42806-810		D	Discontinued by firm	excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	42806-810	42806-810-01	D	Discontinued by firm	excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	42806-810	42806-810-10	D	Discontinued by firm	excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`

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
A040190-001	PHENTERMINE HYDROCHLORIDE	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA		1997-05-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A040190-001	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	A040190-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	1997-05-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040190-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	1997-05-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040190-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	1997-05-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040190-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	1997-05-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040190-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	1997-05-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040190-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	1997-05-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040190-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	1997-05-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040190-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	1997-05-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040190-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	1997-05-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040190-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	1997-05-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040190-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	1997-05-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040190-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	1997-05-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040190-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	1997-05-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040190-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	1997-05-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040190-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	1997-05-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040190-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	1997-05-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040190-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	1997-05-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040190-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	1997-05-30	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040190-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	1997-05-30	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040190-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	1997-05-30	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040190-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	1997-05-30	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040190-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	1997-05-30	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040190-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	1997-05-30	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040190-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	1997-05-30	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040190-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	1997-05-30	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040190-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	1997-05-30	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040190-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	1997-05-30	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040190-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	1997-05-30	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040190-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	1997-05-30	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040190-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	1997-05-30	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040190-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	1997-05-30	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040190-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	1997-05-30	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040190-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	1997-05-30	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040190-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	1997-05-30	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040190-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	1997-05-30	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040190-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	1997-05-30	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040190-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	1997-05-30	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040190-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	1997-05-30	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040190-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	1997-05-30	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A040190-001	PHENTERMINE HYDROCHLORIDE	37.5MG	TABLET / ORAL	AA	1997-05-30	`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	A040190-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040190-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040190-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040190-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040190-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040190-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040190-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040190-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040190-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040190-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040190-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040190-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040190-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040190-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040190-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040190-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040190-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040190-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040190-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040190-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040190-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040190-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040190-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040190-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040190-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040190-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040190-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040190-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040190-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040190-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040190-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040190-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040190-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040190-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040190-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040190-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040190-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040190-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040190-001	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A040190-001	AA	1	`cb3db0bc1861…`

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
42806-810	PHENTERMINE HYDROCHLORIDE TABLET [EPIC PHARMA, LLC]	1	Legacy NDC	20200423_cdbf5c6c-4431-4262-9e6b-9afef85653af.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 · 2 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.	eae1d7f9-733c-434b-9199-5f7052e541da	2026-04-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040190 application number: ANDA040190
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	Elite Laboratories, Inc.	0b7ad9c0-9e1e-4a69-802b-28f44267e34d	2017-04-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040190 application number: ANDA040190

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
42806-810-01	42806081001	100 TABLET in 1 BOTTLE (42806-810-01)	100 tablet	2014-05-01	0000-00-00	No	No	Current
42806-810-10	42806081010	1000 TABLET in 1 BOTTLE (42806-810-10)	1000 tablet	2014-05-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Phentermine Hydrochloride	Epic Pharma, LLC \| Elite Laboratories, Inc.	2020-04-01	HUMAN PRESCRIPTION DRUG LABEL	1