LOMAIRA

Product NDC: 50090-7560
11-digit product format: 500907560
Labeler code: 50090
Product ID: 50090-7560_71a854a1-d9af-4f37-a43c-ba3cafafc2c5
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Phentermine Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: A-S Medication Solutions
Application: ANDA203495
Marketing category: ANDA
Marketing start: 2016-09-12
Substance: PHENTERMINE HYDROCHLORIDE
Active strength: 8 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: 2026-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	50090-7560		D	Discontinued by firm		2026-08-07
excluded package	package	50090-7560	50090-7560-0	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
A203495-001	LOMAIRA	PHENTERMINE HYDROCHLORIDE	8MG	TABLET / ORAL	AA	RS	2016-09-12

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A203495-001	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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A203495-001	LOMAIRA	8MG	TABLET / ORAL	AA	RS	2016-09-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203495-001	LOMAIRA	8MG	TABLET / ORAL	AA	RS	2016-09-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203495-001	LOMAIRA	8MG	TABLET / ORAL	AA	RS	2016-09-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203495-001	LOMAIRA	8MG	TABLET / ORAL	AA	RS	2016-09-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203495-001	LOMAIRA	8MG	TABLET / ORAL	AA	RS	2016-09-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203495-001	LOMAIRA	8MG	TABLET / ORAL	AA	RS	2016-09-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203495-001	LOMAIRA	8MG	TABLET / ORAL	AA	RS	2016-09-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203495-001	LOMAIRA	8MG	TABLET / ORAL	AA	RS	2016-09-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203495-001	LOMAIRA	8MG	TABLET / ORAL	AA	RS	2016-09-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203495-001	LOMAIRA	8MG	TABLET / ORAL	AA	RS	2016-09-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203495-001	LOMAIRA	8MG	TABLET / ORAL	AA	RS	2016-09-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203495-001	LOMAIRA	8MG	TABLET / ORAL	AA	RS	2016-09-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203495-001	LOMAIRA	8MG	TABLET / ORAL	AA	RS	2016-09-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203495-001	LOMAIRA	8MG	TABLET / ORAL	AA	RS	2016-09-12	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203495-001	LOMAIRA	8MG	TABLET / ORAL	AA	RS	2016-09-12	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203495-001	LOMAIRA	8MG	TABLET / ORAL	AA	RS	2016-09-12	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203495-001	LOMAIRA	8MG	TABLET / ORAL	AA	RS	2016-09-12	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203495-001	LOMAIRA	8MG	TABLET / ORAL	AA	RS	2016-09-12	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203495-001	LOMAIRA	8MG	TABLET / ORAL	AA	RS	2016-09-12	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203495-001	LOMAIRA	8MG	TABLET / ORAL	AA	RS	2016-09-12	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A203495-001	LOMAIRA	8MG	TABLET / ORAL	AA	RS	2016-09-12	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A203495-001	LOMAIRA	8MG	TABLET / ORAL	AA	RS	2016-09-12	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A203495-001	LOMAIRA	8MG	TABLET / ORAL	AA	RS	2016-09-12	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A203495-001	LOMAIRA	8MG	TABLET / ORAL	AA	RS	2016-09-12	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A203495-001	LOMAIRA	8MG	TABLET / ORAL	AA	RS	2016-09-12	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A203495-001	LOMAIRA	8MG	TABLET / ORAL	AA	RS	2016-09-12	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A203495-001	LOMAIRA	8MG	TABLET / ORAL	AA	RS	2016-09-12	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A203495-001	LOMAIRA	8MG	TABLET / ORAL	AA	RS	2016-09-12	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A203495-001	LOMAIRA	8MG	TABLET / ORAL	AA	RS	2016-09-12	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A203495-001	LOMAIRA	8MG	TABLET / ORAL	AA	RS	2016-09-12	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A203495-001	LOMAIRA	8MG	TABLET / ORAL	AA	RS	2016-09-12	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A203495-001	LOMAIRA	8MG	TABLET / ORAL	AA	RS	2016-09-12	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A203495-001	LOMAIRA	8MG	TABLET / ORAL	AA	RS	2016-09-12	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A203495-001	LOMAIRA	8MG	TABLET / ORAL	AA	RS	2016-09-12	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A203495-001	LOMAIRA	8MG	TABLET / ORAL	AA	RS	2016-09-12	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A203495-001	LOMAIRA	8MG	TABLET / ORAL	AA	RS	2016-09-12	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A203495-001	LOMAIRA	8MG	TABLET / ORAL	AA	RS	2016-09-12	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A203495-001	LOMAIRA	8MG	TABLET / ORAL	AA	RS	2016-09-12	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A203495-001	LOMAIRA	8MG	TABLET / ORAL	AA	RS	2016-09-12	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A203495-001	LOMAIRA	8MG	TABLET / ORAL	AA	RS	2016-09-12	`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	A203495-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203495-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203495-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203495-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203495-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203495-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203495-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203495-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203495-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203495-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203495-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203495-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203495-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203495-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203495-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203495-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203495-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203495-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203495-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203495-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A203495-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A203495-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A203495-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A203495-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A203495-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A203495-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A203495-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A203495-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A203495-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A203495-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A203495-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A203495-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A203495-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A203495-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A203495-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A203495-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A203495-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A203495-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A203495-001	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A203495-001	AA	1	`cb3db0bc1861…`

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
50090-7560-0	LOMAIRA	90 in 1 BOTTLE	TABLET	90		6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50090-7560-0	EA - Each	50090-7560	8110dde8-44a4-4222-abb5-77b3bcea749e	1	2025-06-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50090-7560	LOMAIRA (PHENTERMINE HYDROCHLORIDE) TABLET [A-S MEDICATION SOLUTIONS]	6	Current NDC, 1 package rows	20250529_329da53b-6f26-4590-be0d-2f20b0ab7b84.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
LOMAIRA	PHENTERMINE HYDROCHLORIDE	Calvin Scott & Co., Inc.	0718f0f3-77f2-45d7-be12-1ed718c8b806	2026-05-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203495 application number: ANDA203495
LOMAIRA	PHENTERMINE HYDROCHLORIDE	KVK-TECH, INC.	cde9fb09-e5af-434d-8874-e4f9f974d893	2023-12-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203495 application number: ANDA203495

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
1810304	Lomaira 8 MG Oral Tablet	PSN	329da53b-6f26-4590-be0d-2f20b0ab7b84	6
826919	phentermine HCl 8 MG Oral Tablet	PSN	329da53b-6f26-4590-be0d-2f20b0ab7b84	6
1810304	phentermine hydrochloride 8 MG Oral Tablet [Lomaira]	SBD	329da53b-6f26-4590-be0d-2f20b0ab7b84	6
826919	phentermine hydrochloride 8 MG Oral Tablet	SCD	329da53b-6f26-4590-be0d-2f20b0ab7b84	6
1810304	Lomaira 8 MG (equivalent to phentermine 6.4 MG) Oral Tablet	SY	329da53b-6f26-4590-be0d-2f20b0ab7b84	6
1810304	Lomaira 8 MG Oral Tablet	SY	329da53b-6f26-4590-be0d-2f20b0ab7b84	6
826919	phentermine HCl 8 MG (equivalent to phentermine 6.4 MG) Oral Tablet	SY	329da53b-6f26-4590-be0d-2f20b0ab7b84	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
50090-7560-0	50090756000	90 TABLET in 1 BOTTLE (50090-7560-0)	90 tablet	2025-05-27	No	No	Historical