Phentermine

Product NDC: 50090-3282
Requested package NDC: 50090-3282-2
11-digit product format: 500903282
Labeler code: 50090
Product ID: 50090-3282_d7050da0-f45b-4b9b-a312-aa70cbfe730b
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: 15 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	50090-3282	50090-3282-2	I	Inactivated by FDA		2026-08-03

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 · 15 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…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`1332a3947898…`	`d4bfe170f9cd…`

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…`

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, Related label table
NDC	Related label
50090-3282-0	These highlights do not include all the information needed to use Phentermine Hydrochloride Capsules, USP CIV safely and effectively. See full prescribing information for Phentermine Hydrochloride Capsules USP PHENTERMINE hydrochloride capsules, for oral use Initial U.S. Approval: 1959
50090-3282-2	These highlights do not include all the information needed to use Phentermine Hydrochloride Capsules, USP CIV safely and effectively. See full prescribing information for Phentermine Hydrochloride Capsules USP PHENTERMINE hydrochloride capsules, for oral use Initial U.S. Approval: 1959
50090-3282-4	These highlights do not include all the information needed to use Phentermine Hydrochloride Capsules, USP CIV safely and effectively. See full prescribing information for Phentermine Hydrochloride Capsules USP PHENTERMINE hydrochloride capsules, for oral use Initial U.S. Approval: 1959
50090-3282-5	These highlights do not include all the information needed to use Phentermine Hydrochloride Capsules, USP CIV safely and effectively. See full prescribing information for Phentermine Hydrochloride Capsules USP PHENTERMINE hydrochloride capsules, for oral use Initial U.S. Approval: 1959

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
50090-3282-0	Phentermine	28 in 1 BOTTLE	CAPSULE	28	16
50090-3282-2	Phentermine	14 in 1 BOTTLE, PLASTIC	CAPSULE	14	16
50090-3282-4	Phentermine	30 in 1 BOTTLE	CAPSULE	30	16
50090-3282-5	Phentermine	60 in 1 BOTTLE	CAPSULE	60	16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50090-3282-0	EA - Each	50090-3282	b00f44b0-9c2c-4c54-8c5f-bad13ea3811f	1	2018-11-06
50090-3282-2	EA - Each	50090-3282	7299df16-c3e8-4534-bf25-39fa5e844de3	1	2021-09-07
50090-3282-4	EA - Each	50090-3282	c5acbc28-4714-4f6b-a395-90c734c891b8	1	2018-11-06
50090-3282-5	EA - Each	50090-3282	338c92fb-5af5-47a9-a449-e25ded93d576	1	2018-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50090-3282	PHENTERMINE (PHENTERMINE HYDROCHLORIDE) CAPSULE [A-S MEDICATION SOLUTIONS]	16	Legacy NDC, 4 package rows	20210818_8229adf5-b128-41a5-a3cc-16db4001801c.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 · 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

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
50090-3282-2	50090328202	14 CAPSULE in 1 BOTTLE, PLASTIC (50090-3282-2)	14 capsule	2017-03-20	0000-00-00	No	No	Current