Mefenamic Acid

Product NDC: 80425-0306
11-digit product format: 804250306
Labeler code: 80425
Product ID: 80425-0306_2a9ba8f4-6cef-e827-e063-6394a90a0300
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Mefenamic Acid
Dosage form: CAPSULE
Route: ORAL
Labeler: Advanced Rx Pharmacy of Tennessee, LLC
Application: ANDA090562
Marketing category: ANDA
Marketing start: 2023-04-06
Substance: MEFENAMIC ACID
Active strength: 250 mg/1
Pharmacologic classes: Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A090562-001	MEFENAMIC ACID	MEFENAMIC ACID	250MG	CAPSULE / ORAL	AB		2010-11-19

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A090562-001	AB

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 · 42 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
2026-08-18 06:07:40	2026-07	A090562-001	MEFENAMIC ACID	250MG	CAPSULE / ORAL	AB	2010-11-19	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090562-001	MEFENAMIC ACID	250MG	CAPSULE / ORAL	AB	2010-11-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090562-001	MEFENAMIC ACID	250MG	CAPSULE / ORAL	AB	2010-11-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090562-001	MEFENAMIC ACID	250MG	CAPSULE / ORAL	AB	2010-11-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090562-001	MEFENAMIC ACID	250MG	CAPSULE / ORAL	AB	2010-11-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090562-001	MEFENAMIC ACID	250MG	CAPSULE / ORAL	AB	2010-11-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090562-001	MEFENAMIC ACID	250MG	CAPSULE / ORAL	AB	2010-11-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090562-001	MEFENAMIC ACID	250MG	CAPSULE / ORAL	AB	2010-11-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090562-001	MEFENAMIC ACID	250MG	CAPSULE / ORAL	AB	2010-11-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090562-001	MEFENAMIC ACID	250MG	CAPSULE / ORAL	AB	2010-11-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090562-001	MEFENAMIC ACID	250MG	CAPSULE / ORAL	AB	2010-11-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090562-001	MEFENAMIC ACID	250MG	CAPSULE / ORAL	AB	2010-11-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090562-001	MEFENAMIC ACID	250MG	CAPSULE / ORAL	AB	2010-11-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090562-001	MEFENAMIC ACID	250MG	CAPSULE / ORAL	AB	2010-11-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090562-001	MEFENAMIC ACID	250MG	CAPSULE / ORAL	AB	2010-11-19	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090562-001	MEFENAMIC ACID	250MG	CAPSULE / ORAL	AB	2010-11-19	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090562-001	MEFENAMIC ACID	250MG	CAPSULE / ORAL	AB	2010-11-19	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090562-001	MEFENAMIC ACID	250MG	CAPSULE / ORAL	AB	2010-11-19	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090562-001	MEFENAMIC ACID	250MG	CAPSULE / ORAL	AB	2010-11-19	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090562-001	MEFENAMIC ACID	250MG	CAPSULE / ORAL	AB	2010-11-19	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090562-001	MEFENAMIC ACID	250MG	CAPSULE / ORAL	AB	2010-11-19	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090562-001	MEFENAMIC ACID	250MG	CAPSULE / ORAL	AB	2010-11-19	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090562-001	MEFENAMIC ACID	250MG	CAPSULE / ORAL	AB	2010-11-19	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090562-001	MEFENAMIC ACID	250MG	CAPSULE / ORAL	AB	2010-11-19	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090562-001	MEFENAMIC ACID	250MG	CAPSULE / ORAL	AB	2010-11-19	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090562-001	MEFENAMIC ACID	250MG	CAPSULE / ORAL	AB	2010-11-19	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090562-001	MEFENAMIC ACID	250MG	CAPSULE / ORAL	AB	2010-11-19	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090562-001	MEFENAMIC ACID	250MG	CAPSULE / ORAL	AB	2010-11-19	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090562-001	MEFENAMIC ACID	250MG	CAPSULE / ORAL	AB	2010-11-19	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090562-001	MEFENAMIC ACID	250MG	CAPSULE / ORAL	AB	2010-11-19	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090562-001	MEFENAMIC ACID	250MG	CAPSULE / ORAL	AB	2010-11-19	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090562-001	MEFENAMIC ACID	250MG	CAPSULE / ORAL	AB	2010-11-19	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090562-001	MEFENAMIC ACID	250MG	CAPSULE / ORAL	AB	2010-11-19	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090562-001	MEFENAMIC ACID	250MG	CAPSULE / ORAL	AB	2010-11-19	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090562-001	MEFENAMIC ACID	250MG	CAPSULE / ORAL	AB	2010-11-19	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090562-001	MEFENAMIC ACID	250MG	CAPSULE / ORAL	AB	2010-11-19	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090562-001	MEFENAMIC ACID	250MG	CAPSULE / ORAL	AB	2010-11-19	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090562-001	MEFENAMIC ACID	250MG	CAPSULE / ORAL	AB	2010-11-19	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090562-001	MEFENAMIC ACID	250MG	CAPSULE / ORAL	AB	2010-11-19	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A090562-001	MEFENAMIC ACID	250MG	CAPSULE / ORAL	AB	2010-11-19	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A090562-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090562-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090562-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090562-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090562-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090562-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090562-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090562-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090562-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090562-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090562-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090562-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090562-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090562-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090562-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090562-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090562-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090562-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090562-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090562-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090562-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090562-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090562-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090562-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090562-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090562-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090562-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090562-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090562-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090562-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090562-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090562-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090562-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090562-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090562-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090562-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090562-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090562-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090562-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A090562-001	AB	1	`e64feba35796…`

Additional Listing Data#

Finished product: Yes
Brand name base: Mefenamic Acid
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
MEFENAMIC ACID	250 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
367589PJ2C	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
829500	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
f8b1a4a2-83fc-6b4b-e053-6394a90ac46a	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
4e49f7b3-969c-15d1-c46f-04e94dac5598	Product name	2	20150108

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
80425-0306-1	Mefenamic Acid	30 in 1 BOTTLE	CAPSULE	30	2
80425-0306-2	Mefenamic Acid	60 in 1 BOTTLE	CAPSULE	60	2
80425-0306-3	Mefenamic Acid	90 in 1 BOTTLE	CAPSULE	90	2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
80425-0306-1	EA - Each	80425-0306	dcf74e20-fdb3-4393-b80f-bb34e649da61	1	2023-06-06
80425-0306-2	EA - Each	80425-0306	0680efaa-6c6c-47df-9f0e-47ebdc0851fd	1	2023-06-06
80425-0306-3	EA - Each	80425-0306	f88b4fa9-824f-4606-9931-d7c5f3c6eceb	1	2023-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
80425-0306	MEFENAMIC ACID CAPSULE [ADVANCED RX PHARMACY OF TENNESSEE, LLC]	2	Current NDC, 3 package rows	20250102_f8b1a4a2-83fc-6b4b-e053-6394a90ac46a.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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Mefenamic acid	MEFENAMIC ACID	Bryant Ranch Prepack	9b8b3e03-4801-4ae8-b44e-e01d1ab1e34b	2026-03-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090562 application number: ANDA090562
Mefenamic acid	MEFENAMIC ACID	Micro Labs Limited	4b0788cd-bdca-4fa5-9eba-01a270613aab	2026-01-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090562 application number: ANDA090562
Mefenamic Acid	MEFENAMIC ACID	Advanced Rx Pharmacy of Tennessee, LLC	f8b1a4a2-83fc-6b4b-e053-6394a90ac46a	2024-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090562 application number: ANDA090562 ndc (product): 80425-0306

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
367589PJ2C	MEFENAMIC ACID	61-68-7	MEFENAMIC ACID

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
829500	mefenamic acid 250 MG Oral Capsule	PSN	f8b1a4a2-83fc-6b4b-e053-6394a90ac46a	2
829500	mefenamic acid 250 MG Oral Capsule	SCD	f8b1a4a2-83fc-6b4b-e053-6394a90ac46a	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
80425-0306-1	80425030601	30 CAPSULE in 1 BOTTLE (80425-0306-1)	30 capsule	2023-04-06	No	No	Current
80425-0306-2	80425030602	60 CAPSULE in 1 BOTTLE (80425-0306-2)	60 capsule	2023-04-06	No	No	Current
80425-0306-3	80425030603	90 CAPSULE in 1 BOTTLE (80425-0306-3)	90 capsule	2023-04-06	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Mefenamic Acid Capsules	Advanced Rx Pharmacy of Tennessee, LLC	2024-12-31	HUMAN PRESCRIPTION DRUG LABEL	2