Phentermine Hydrochloride

Product NDC: 50090-0653
11-digit product format: 500900653
Labeler code: 50090
Product ID: 50090-0653_de2d050e-ec9e-4b7a-8716-f59cf8464507
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Phentermine Hydrochloride
Dosage form: CAPSULE
Route: ORAL
Labeler: A-S Medication Solutions
Application: ANDA040887
Marketing category: ANDA
Marketing start: 2012-08-15
Substance: PHENTERMINE HYDROCHLORIDE
Active strength: 37.5 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: 2027-12-31
Current FDA listing: Yes

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	50090-0653	50090-0653-0	D	Discontinued by firm		2026-08-07

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
A040887-001	PHENTERMINE HYDROCHLORIDE	PHENTERMINE HYDROCHLORIDE	37.5MG	CAPSULE / ORAL	AA		2008-04-24

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A040887-001	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	A040887-001	PHENTERMINE HYDROCHLORIDE	37.5MG	CAPSULE / ORAL	AA	2008-04-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040887-001	PHENTERMINE HYDROCHLORIDE	37.5MG	CAPSULE / ORAL	AA	2008-04-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040887-001	PHENTERMINE HYDROCHLORIDE	37.5MG	CAPSULE / ORAL	AA	2008-04-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040887-001	PHENTERMINE HYDROCHLORIDE	37.5MG	CAPSULE / ORAL	AA	2008-04-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040887-001	PHENTERMINE HYDROCHLORIDE	37.5MG	CAPSULE / ORAL	AA	2008-04-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040887-001	PHENTERMINE HYDROCHLORIDE	37.5MG	CAPSULE / ORAL	AA	2008-04-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040887-001	PHENTERMINE HYDROCHLORIDE	37.5MG	CAPSULE / ORAL	AA	2008-04-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040887-001	PHENTERMINE HYDROCHLORIDE	37.5MG	CAPSULE / ORAL	AA	2008-04-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040887-001	PHENTERMINE HYDROCHLORIDE	37.5MG	CAPSULE / ORAL	AA	2008-04-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040887-001	PHENTERMINE HYDROCHLORIDE	37.5MG	CAPSULE / ORAL	AA	2008-04-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040887-001	PHENTERMINE HYDROCHLORIDE	37.5MG	CAPSULE / ORAL	AA	2008-04-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040887-001	PHENTERMINE HYDROCHLORIDE	37.5MG	CAPSULE / ORAL	AA	2008-04-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040887-001	PHENTERMINE HYDROCHLORIDE	37.5MG	CAPSULE / ORAL	AA	2008-04-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040887-001	PHENTERMINE HYDROCHLORIDE	37.5MG	CAPSULE / ORAL	AA	2008-04-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040887-001	PHENTERMINE HYDROCHLORIDE	37.5MG	CAPSULE / ORAL	AA	2008-04-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040887-001	PHENTERMINE HYDROCHLORIDE	37.5MG	CAPSULE / ORAL	AA	2008-04-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040887-001	PHENTERMINE HYDROCHLORIDE	37.5MG	CAPSULE / ORAL	AA	2008-04-24	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040887-001	PHENTERMINE HYDROCHLORIDE	37.5MG	CAPSULE / ORAL	AA	2008-04-24	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040887-001	PHENTERMINE HYDROCHLORIDE	37.5MG	CAPSULE / ORAL	AA	2008-04-24	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040887-001	PHENTERMINE HYDROCHLORIDE	37.5MG	CAPSULE / ORAL	AA	2008-04-24	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040887-001	PHENTERMINE HYDROCHLORIDE	37.5MG	CAPSULE / ORAL	AA	2008-04-24	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040887-001	PHENTERMINE HYDROCHLORIDE	37.5MG	CAPSULE / ORAL	AA	2008-04-24	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040887-001	PHENTERMINE HYDROCHLORIDE	37.5MG	CAPSULE / ORAL	AA	2008-04-24	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040887-001	PHENTERMINE HYDROCHLORIDE	37.5MG	CAPSULE / ORAL	AA	2008-04-24	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040887-001	PHENTERMINE HYDROCHLORIDE	37.5MG	CAPSULE / ORAL	AA	2008-04-24	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040887-001	PHENTERMINE HYDROCHLORIDE	37.5MG	CAPSULE / ORAL	AA	2008-04-24	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040887-001	PHENTERMINE HYDROCHLORIDE	37.5MG	CAPSULE / ORAL	AA	2008-04-24	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040887-001	PHENTERMINE HYDROCHLORIDE	37.5MG	CAPSULE / ORAL	AA	2008-04-24	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040887-001	PHENTERMINE HYDROCHLORIDE	37.5MG	CAPSULE / ORAL	AA	2008-04-24	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040887-001	PHENTERMINE HYDROCHLORIDE	37.5MG	CAPSULE / ORAL	AA	2008-04-24	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040887-001	PHENTERMINE HYDROCHLORIDE	37.5MG	CAPSULE / ORAL	AA	2008-04-24	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040887-001	PHENTERMINE HYDROCHLORIDE	37.5MG	CAPSULE / ORAL	AA	2008-04-24	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040887-001	PHENTERMINE HYDROCHLORIDE	37.5MG	CAPSULE / ORAL	AA	2008-04-24	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040887-001	PHENTERMINE HYDROCHLORIDE	37.5MG	CAPSULE / ORAL	AA	2008-04-24	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040887-001	PHENTERMINE HYDROCHLORIDE	37.5MG	CAPSULE / ORAL	AA	2008-04-24	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040887-001	PHENTERMINE HYDROCHLORIDE	37.5MG	CAPSULE / ORAL	AA	2008-04-24	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040887-001	PHENTERMINE HYDROCHLORIDE	37.5MG	CAPSULE / ORAL	AA	2008-04-24	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040887-001	PHENTERMINE HYDROCHLORIDE	37.5MG	CAPSULE / ORAL	AA	2008-04-24	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040887-001	PHENTERMINE HYDROCHLORIDE	37.5MG	CAPSULE / ORAL	AA	2008-04-24	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A040887-001	PHENTERMINE HYDROCHLORIDE	37.5MG	CAPSULE / ORAL	AA	2008-04-24	`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	A040887-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040887-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040887-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040887-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040887-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040887-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040887-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040887-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040887-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040887-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040887-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040887-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040887-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040887-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040887-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040887-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040887-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040887-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040887-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040887-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040887-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040887-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040887-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040887-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040887-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040887-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040887-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040887-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040887-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040887-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040887-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040887-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040887-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040887-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040887-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040887-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040887-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040887-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040887-001	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A040887-001	AA	1	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: Phentermine Hydrochloride
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
PHENTERMINE HYDROCHLORIDE	37.5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
0K2I505OTV	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
803348	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
ea798229-fc2d-417c-9bc9-a3b942f0b64b	Available on FDA.report

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, Related label table
NDC	Effective	Related label
50090-0653-0	2023-02-07	These highlights do not include all the information needed to use Phentermine Hydrochloride Tablets and Capsules, USP 37.5 mg safely and effectively. See full prescribing information for Phentermine Hydrochloride Tablets and Capsules, USP 37.5 mg. Phentermine Hydrochloride Tablets and Capsules, USP 37.5 mg (phentermine hydrochloride, USP) CIV for oral use Initial U.S. Approval: 1959
50090-0653-1	2023-02-07	These highlights do not include all the information needed to use Phentermine Hydrochloride Tablets and Capsules, USP 37.5 mg safely and effectively. See full prescribing information for Phentermine Hydrochloride Tablets and Capsules, USP 37.5 mg. Phentermine Hydrochloride Tablets and Capsules, USP 37.5 mg (phentermine hydrochloride, USP) CIV for oral use Initial U.S. Approval: 1959
50090-0653-2	2023-02-07	These highlights do not include all the information needed to use Phentermine Hydrochloride Tablets and Capsules, USP 37.5 mg safely and effectively. See full prescribing information for Phentermine Hydrochloride Tablets and Capsules, USP 37.5 mg. Phentermine Hydrochloride Tablets and Capsules, USP 37.5 mg (phentermine hydrochloride, USP) CIV for oral use Initial U.S. Approval: 1959
50090-0653-0	2023-01-30	These highlights do not include all the information needed to use Phentermine Hydrochloride Tablets and Capsules, USP 37.5 mg safely and effectively. See full prescribing information for Phentermine Hydrochloride Tablets and Capsules, USP 37.5 mg. Phentermine Hydrochloride Tablets and Capsules, USP 37.5 mg (phentermine hydrochloride, USP) CIV for oral use Initial U.S. Approval: 1959
50090-0653-1	2023-01-30	These highlights do not include all the information needed to use Phentermine Hydrochloride Tablets and Capsules, USP 37.5 mg safely and effectively. See full prescribing information for Phentermine Hydrochloride Tablets and Capsules, USP 37.5 mg. Phentermine Hydrochloride Tablets and Capsules, USP 37.5 mg (phentermine hydrochloride, USP) CIV for oral use Initial U.S. Approval: 1959
50090-0653-2	2023-01-30	These highlights do not include all the information needed to use Phentermine Hydrochloride Tablets and Capsules, USP 37.5 mg safely and effectively. See full prescribing information for Phentermine Hydrochloride Tablets and Capsules, USP 37.5 mg. Phentermine Hydrochloride Tablets and Capsules, USP 37.5 mg (phentermine hydrochloride, USP) CIV for oral use Initial U.S. Approval: 1959

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
50090-0653-0	Phentermine Hydrochloride	1000 in 1 BOTTLE	CAPSULE	1000	29
50090-0653-1	Phentermine Hydrochloride	30 in 1 BOTTLE	CAPSULE	30	29
50090-0653-2	Phentermine Hydrochloride	28 in 1 BOTTLE	CAPSULE	28	29

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50090-0653-1	EA - Each	50090-0653	f31a5a21-bf7b-41ab-affb-5f8488fcf5ef	1	2018-10-11
50090-0653-2	EA - Each	50090-0653	e2f0ca15-b738-4b34-9016-b88ca223c2f2	1	2018-10-11

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
PHENTERMINE HYDROCHLORIDE	ACTIVE INGREDIENT	0K2I505OTV	PHENTERMINE HYDROCHLORIDE TABLET PHENTERMINE HYDROCHLORIDE CAPSULE [A-S MEDICATION SOLUTIONS LLC]	1
PHENTERMINE	ACTIVE MOIETY	C045TQL4WP	PHENTERMINE HYDROCHLORIDE TABLET PHENTERMINE HYDROCHLORIDE CAPSULE [A-S MEDICATION SOLUTIONS LLC]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	PHENTERMINE HYDROCHLORIDE TABLET PHENTERMINE HYDROCHLORIDE CAPSULE [A-S MEDICATION SOLUTIONS LLC]	1
D&C RED NO. 33	INACTIVE INGREDIENT	9DBA0SBB0L	PHENTERMINE HYDROCHLORIDE TABLET PHENTERMINE HYDROCHLORIDE CAPSULE [A-S MEDICATION SOLUTIONS LLC]	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	PHENTERMINE HYDROCHLORIDE TABLET PHENTERMINE HYDROCHLORIDE CAPSULE [A-S MEDICATION SOLUTIONS LLC]	1
GELATIN	INACTIVE INGREDIENT	2G86QN327L	PHENTERMINE HYDROCHLORIDE TABLET PHENTERMINE HYDROCHLORIDE CAPSULE [A-S MEDICATION SOLUTIONS LLC]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	PHENTERMINE HYDROCHLORIDE TABLET PHENTERMINE HYDROCHLORIDE CAPSULE [A-S MEDICATION SOLUTIONS LLC]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	PHENTERMINE HYDROCHLORIDE TABLET PHENTERMINE HYDROCHLORIDE CAPSULE [A-S MEDICATION SOLUTIONS LLC]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	PHENTERMINE HYDROCHLORIDE TABLET PHENTERMINE HYDROCHLORIDE CAPSULE [A-S MEDICATION SOLUTIONS LLC]	1
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	PHENTERMINE HYDROCHLORIDE TABLET PHENTERMINE HYDROCHLORIDE CAPSULE [A-S MEDICATION SOLUTIONS LLC]	1
SUCROSE	INACTIVE INGREDIENT	C151H8M554	PHENTERMINE HYDROCHLORIDE TABLET PHENTERMINE HYDROCHLORIDE CAPSULE [A-S MEDICATION SOLUTIONS LLC]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	PHENTERMINE HYDROCHLORIDE TABLET PHENTERMINE HYDROCHLORIDE CAPSULE [A-S MEDICATION SOLUTIONS LLC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50090-0653	PHENTERMINE HYDROCHLORIDE CAPSULE [A-S MEDICATION SOLUTIONS]	27	Current NDC, Legacy NDC, 3 package rows	20240215_ea798229-fc2d-417c-9bc9-a3b942f0b64b.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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Phentermine	PHENTERMINE HYDROCHLORIDE	Calvin Scott & Co., Inc.	27e88ebe-6247-4598-8ef2-c882992ed579	2026-05-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040887 application number: ANDA040887
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	A-S Medication Solutions	ea798229-fc2d-417c-9bc9-a3b942f0b64b	2026-01-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040887 application number: ANDA040887 ndc (product): 50090-0653
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	378d863a-6977-4543-ae50-c3684a6abd9b	2025-10-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040887 application number: ANDA040887
Phentermine Hydrochloride	PHENTERMINE HYDROCHLORIDE	KVK-TECH, Inc.	3b44d104-a7d0-4366-9d42-63f784f3cb22	2024-02-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040887 application number: ANDA040887

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
803348	phentermine HCl 37.5 MG Oral Capsule	PSN	ea798229-fc2d-417c-9bc9-a3b942f0b64b	29
803348	phentermine hydrochloride 37.5 MG Oral Capsule	SCD	ea798229-fc2d-417c-9bc9-a3b942f0b64b	29
803348	phentermine hydrochloride 37.5 MG (equivalent to phentermine 30 MG) Oral Capsule	SY	ea798229-fc2d-417c-9bc9-a3b942f0b64b	29

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50090-0653-0	50090065300	1000 CAPSULE in 1 BOTTLE (50090-0653-0)	1000 capsule	2019-10-09	0000-00-00	No	No	Current
50090-0653-1	50090065301	30 CAPSULE in 1 BOTTLE (50090-0653-1)	30 capsule	2014-11-28	0000-00-00	No	No	Current
50090-0653-2	50090065302	28 CAPSULE in 1 BOTTLE (50090-0653-2)	28 capsule	2014-11-28	0000-00-00	No	No	Current