Mefenamic acid

Product NDC
72162-2382
11-digit product format
721622382
Labeler code
72162
Product ID
72162-2382_4b2e7b09-e271-4303-8dc3-4fedd8430383
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Mefenamic acid
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA090562
Marketing category
ANDA
Marketing start
2010-11-19
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
2027-12-31
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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A090562-001MEFENAMIC ACIDMEFENAMIC ACID250MGCAPSULE / ORALAB2010-11-19

Therapeutic equivalence codes#

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

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

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A090562-001MEFENAMIC ACID250MGCAPSULE / ORALAB2010-11-19caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A090562-001MEFENAMIC ACID250MGCAPSULE / ORALAB2010-11-19011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090562-001MEFENAMIC ACID250MGCAPSULE / ORALAB2010-11-1931067a03dcf5…
2025-08-23 18:47 UTC2025-08A090562-001MEFENAMIC ACID250MGCAPSULE / ORALAB2010-11-196a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090562-001MEFENAMIC ACID250MGCAPSULE / ORALAB2010-11-19fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090562-001MEFENAMIC ACID250MGCAPSULE / ORALAB2010-11-19b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090562-001MEFENAMIC ACID250MGCAPSULE / ORALAB2010-11-1903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090562-001MEFENAMIC ACID250MGCAPSULE / ORALAB2010-11-192680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090562-001MEFENAMIC ACID250MGCAPSULE / ORALAB2010-11-195bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090562-001MEFENAMIC ACID250MGCAPSULE / ORALAB2010-11-19d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090562-001MEFENAMIC ACID250MGCAPSULE / ORALAB2010-11-19d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090562-001MEFENAMIC ACID250MGCAPSULE / ORALAB2010-11-1979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090562-001MEFENAMIC ACID250MGCAPSULE / ORALAB2010-11-19301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090562-001MEFENAMIC ACID250MGCAPSULE / ORALAB2010-11-191e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090562-001MEFENAMIC ACID250MGCAPSULE / ORALAB2010-11-198072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090562-001MEFENAMIC ACID250MGCAPSULE / ORALAB2010-11-195c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A090562-001MEFENAMIC ACID250MGCAPSULE / ORALAB2010-11-195d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A090562-001MEFENAMIC ACID250MGCAPSULE / ORALAB2010-11-194b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A090562-001MEFENAMIC ACID250MGCAPSULE / ORALAB2010-11-1974a2ff9319b5…
2022-03-09 01:35 UTC2022-03A090562-001MEFENAMIC ACID250MGCAPSULE / ORALAB2010-11-19bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A090562-001MEFENAMIC ACID250MGCAPSULE / ORALAB2010-11-19782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A090562-001MEFENAMIC ACID250MGCAPSULE / ORALAB2010-11-1987673890dc5c…
2021-03-12 10:30 UTC2021-03A090562-001MEFENAMIC ACID250MGCAPSULE / ORALAB2010-11-195aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A090562-001MEFENAMIC ACID250MGCAPSULE / ORALAB2010-11-198869cabd3fbd…
2020-11-12 02:37 UTC2020-11A090562-001MEFENAMIC ACID250MGCAPSULE / ORALAB2010-11-19c0c555d07b60…
2019-12-14 00:12 UTC2019-12A090562-001MEFENAMIC ACID250MGCAPSULE / ORALAB2010-11-193f01610625f2…
2019-09-15 20:21 UTC2019-09A090562-001MEFENAMIC ACID250MGCAPSULE / ORALAB2010-11-19b00525d2431f…
2019-07-19 19:46 UTC2019-07A090562-001MEFENAMIC ACID250MGCAPSULE / ORALAB2010-11-19ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A090562-001MEFENAMIC ACID250MGCAPSULE / ORALAB2010-11-196a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A090562-001MEFENAMIC ACID250MGCAPSULE / ORALAB2010-11-191c564ffb4f44…
2023-12-20 04:57 UTC2023-12A090562-001MEFENAMIC ACID250MGCAPSULE / ORALAB2010-11-19ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A090562-001MEFENAMIC ACID250MGCAPSULE / ORALAB2010-11-19a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A090562-001MEFENAMIC ACID250MGCAPSULE / ORALAB2010-11-199b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A090562-001MEFENAMIC ACID250MGCAPSULE / ORALAB2010-11-19a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A090562-001MEFENAMIC ACID250MGCAPSULE / ORALAB2010-11-193f0d92c62455…
2023-05-13 08:27 UTC2023-05A090562-001MEFENAMIC ACID250MGCAPSULE / ORALAB2010-11-19053a50430f4f…
2023-01-26 05:58 UTC2023-01A090562-001MEFENAMIC ACID250MGCAPSULE / ORALAB2010-11-193bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A090562-001MEFENAMIC ACID250MGCAPSULE / ORALAB2010-11-193a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A090562-001MEFENAMIC ACID250MGCAPSULE / ORALAB2010-11-19f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A090562-001MEFENAMIC ACID250MGCAPSULE / ORALAB2010-11-19e64feba35796…

Observed Orange Book normalized TE history#

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

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A090562-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A090562-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090562-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A090562-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090562-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090562-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090562-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090562-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090562-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090562-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090562-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090562-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090562-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090562-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090562-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090562-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A090562-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A090562-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A090562-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A090562-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A090562-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A090562-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A090562-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A090562-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A090562-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A090562-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A090562-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A090562-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A090562-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A090562-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A090562-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A090562-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A090562-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A090562-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A090562-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A090562-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A090562-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A090562-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A090562-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A090562-001AB1e64feba35796…

Additional Listing Data#

Finished product
Yes
Brand name base
Mefenamic acid
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MEFENAMIC ACID250 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
367589PJ2CInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
829500Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
9b8b3e03-4801-4ae8-b44e-e01d1ab1e34bAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4e49f7b3-969c-15d1-c46f-04e94dac5598Product name220150108

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72162-2382-3Mefenamic acid30 in 1 BOTTLECAPSULE30102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72162-2382-3EA - Each72162-23823dbc6066-dce6-4d5a-a58c-3646ed46fdf912024-11-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72162-2382MEFENAMIC ACID (MEFENAMIC ACID) CAPSULE [BRYANT RANCH PREPACK]101Current NDC, 1 package rows20250521_9b8b3e03-4801-4ae8-b44e-e01d1ab1e34b.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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Mefenamic acidMEFENAMIC ACIDBryant Ranch Prepack9b8b3e03-4801-4ae8-b44e-e01d1ab1e34b2026-03-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090562
application number: ANDA090562
ndc (product): 72162-2382
Mefenamic acidMEFENAMIC ACIDMicro Labs Limited4b0788cd-bdca-4fa5-9eba-01a270613aab2026-01-12Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090562
application number: ANDA090562
Mefenamic AcidMEFENAMIC ACIDAdvanced Rx Pharmacy of Tennessee, LLCf8b1a4a2-83fc-6b4b-e053-6394a90ac46a2024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090562
application number: ANDA090562

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
829500mefenamic acid 250 MG Oral CapsulePSN9b8b3e03-4801-4ae8-b44e-e01d1ab1e34b102
829500mefenamic acid 250 MG Oral CapsuleSCD9b8b3e03-4801-4ae8-b44e-e01d1ab1e34b102

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72162-2382-37216223820330 CAPSULE in 1 BOTTLE (72162-2382-3) 30 capsule2010-11-19NoNoCurrent