Phentermine

Product NDC: 50090-3306
Requested package NDC: 50090-3306-0
11-digit product format: 500903306
Labeler code: 50090
Product ID: 50090-3306_49c1d86e-31b5-4e02-9cd0-5780cd564df1
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Phentermine Hydrochloride
Dosage form: CAPSULE
Route: ORAL
Labeler: A-S Medication Solutions
Application: ANDA204318
Marketing category: ANDA
Marketing start: 2017-03-20
Marketing end: 0000-00-00
Substance: PHENTERMINE HYDROCHLORIDE
Active strength: 30 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#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

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	50090-3306	50090-3306-0	D	Discontinued by firm		2026-08-03

Observed NDC auxiliary status history#

Observed captured status history: Rows come only from successfully parsed FDA auxiliary ZIP captures. They show the state present in that artifact, not a continuous regulatory timeline. Absence before, after, or between captures is not proof of status, and a known non-data HTTP 403 capture is preserved in backfill provenance but cannot produce a status row.

Historic NDC status page 1 of 1 · 12 matching rows.

Browse every current auxiliary row. · Browse the complete NDC auxiliary source catalog.

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 package	package	50090-3306	50090-3306-0	D	Discontinued by firm	excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	50090-3306	50090-3306-0	D	Discontinued by firm	excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	50090-3306	50090-3306-0	D	Discontinued by firm	excluded / ndc_excluded.zip	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	50090-3306	50090-3306-0	D	Discontinued by firm	excluded / ndc_excluded.zip	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	50090-3306	50090-3306-0	D	Discontinued by firm	excluded / ndc_excluded.zip	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	50090-3306	50090-3306-0	D	Discontinued by firm	excluded / ndc_excluded.zip	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	50090-3306	50090-3306-0	D	Discontinued by firm	excluded / ndc_excluded.zip	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	50090-3306	50090-3306-0	D	Discontinued by firm	excluded / ndc_excluded.zip	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	50090-3306	50090-3306-0	D	Discontinued by firm	excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	50090-3306	50090-3306-0	D	Discontinued by firm	excluded / ndc_excluded.zip	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	50090-3306	50090-3306-0	D	Discontinued by firm	excluded / ndc_excluded.zip	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	50090-3306	50090-3306-0	D	Discontinued by firm	excluded / ndc_excluded.zip	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A204318-001	PHENTERMINE HYDROCHLORIDE	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL	AA		2016-11-09
A204318-002	PHENTERMINE HYDROCHLORIDE	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA		2016-11-09

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A204318-001	AA
A204318-002	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 3 · 82 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	A204318-001	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL	AA	2016-11-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204318-002	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	2016-11-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204318-001	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL	AA	2016-11-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204318-002	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	2016-11-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204318-001	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL	AA	2016-11-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204318-002	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	2016-11-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204318-001	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL	AA	2016-11-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204318-002	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	2016-11-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204318-001	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL	AA	2016-11-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204318-002	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	2016-11-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204318-001	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL	AA	2016-11-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204318-002	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	2016-11-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204318-001	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL	AA	2016-11-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204318-002	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	2016-11-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204318-001	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL	AA	2016-11-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204318-002	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	2016-11-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204318-001	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL	AA	2016-11-09	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204318-002	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	2016-11-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204318-001	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL	AA	2016-11-09	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204318-002	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	2016-11-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204318-001	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL	AA	2016-11-09	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204318-002	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	2016-11-09	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204318-001	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL	AA	2016-11-09	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204318-002	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	2016-11-09	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204318-001	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL	AA	2016-11-09	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204318-002	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	2016-11-09	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204318-001	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL	AA	2016-11-09	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A204318-002	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	2016-11-09	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204318-001	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL	AA	2016-11-09	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204318-002	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	2016-11-09	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204318-001	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL	AA	2016-11-09	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A204318-002	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	2016-11-09	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204318-001	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL	AA	2016-11-09	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A204318-002	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	2016-11-09	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204318-001	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL	AA	2016-11-09	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A204318-002	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	2016-11-09	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204318-001	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL	AA	2016-11-09	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A204318-002	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	2016-11-09	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204318-001	PHENTERMINE HYDROCHLORIDE	15MG	CAPSULE / ORAL	AA	2016-11-09	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A204318-002	PHENTERMINE HYDROCHLORIDE	30MG	CAPSULE / ORAL	AA	2016-11-09	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 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	A204318-001	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204318-002	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204318-001	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204318-002	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204318-001	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204318-002	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204318-001	AA	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204318-002	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204318-001	AA	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204318-002	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204318-001	AA	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204318-002	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204318-001	AA	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204318-002	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204318-001	AA	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204318-002	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204318-001	AA	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204318-002	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204318-001	AA	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204318-002	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204318-001	AA	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204318-002	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204318-001	AA	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204318-002	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204318-001	AA	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204318-002	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204318-001	AA	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A204318-002	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204318-001	AA	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204318-002	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204318-001	AA	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A204318-002	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204318-001	AA	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A204318-002	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204318-001	AA	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A204318-002	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204318-001	AA	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A204318-002	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204318-001	AA	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A204318-002	AA	1	`782e0a99824c…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Phentermine	PHENTERMINE HYDROCHLORIDE	Aurolife Pharma, LLC	737eef3b-9a6b-4ab3-a25c-49d84d2a0197	2019-01-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204318 application number: ANDA204318

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	Strength	SPL version
50090-3306-0	Phentermine	30 in 1 BOTTLE	CAPSULE	30		16
50090-3306-4	Phentermine	28 in 1 BOTTLE	CAPSULE	28		16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50090-3306-0	EA - Each	50090-3306	76b42ea8-59d0-417b-8cb5-099f42ba1a11	1	2018-10-11
50090-3306-4	EA - Each	50090-3306	96b73634-99cd-4695-bc5e-665c98c5b3a0	1	2018-10-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50090-3306	PHENTERMINE (PHENTERMINE HYDROCHLORIDE) CAPSULE [A-S MEDICATION SOLUTIONS]	16	Legacy NDC, 2 package rows	20210818_8229adf5-b128-41a5-a3cc-16db4001801c.zip

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
968766	phentermine HCl 15 MG Oral Capsule	PSN	8229adf5-b128-41a5-a3cc-16db4001801c	16
900038	phentermine HCl 30 MG Oral Capsule	PSN	8229adf5-b128-41a5-a3cc-16db4001801c	16
968766	phentermine hydrochloride 15 MG Oral Capsule	SCD	8229adf5-b128-41a5-a3cc-16db4001801c	16
900038	phentermine hydrochloride 30 MG Oral Capsule	SCD	8229adf5-b128-41a5-a3cc-16db4001801c	16
968766	phentermine hydrochloride 15 MG (equivalent to phentermine 12 MG) Oral Capsule	SY	8229adf5-b128-41a5-a3cc-16db4001801c	16
900038	phentermine hydrochloride 30 MG (equivalent to phentermine 24 MG) Oral Capsule	SY	8229adf5-b128-41a5-a3cc-16db4001801c	16

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50090-3306-0	50090330600	30 CAPSULE in 1 BOTTLE (50090-3306-0)	30 capsule	2017-12-18	0000-00-00	No	No	Current