Home NDC 80425-0423 Mefenamic Acid
Product NDC 80425-0423
11-digit product format 804250423
Labeler code 80425
Product ID 80425-0423_1e927779-411b-b5f5-e063-6394a90aae93
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Mefenamic Acid
Dosage form CAPSULE
Route ORAL
Labeler Advanced Rx of Tennessee, LLC
Application ANDA091322
Marketing category ANDA
Marketing start 2024-07-19
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 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 A091322-001 MEFENAMIC ACID MEFENAMIC ACID 250MG CAPSULE / ORAL AB 2011-07-22
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A091322-001 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 RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 A091322-001 MEFENAMIC ACID 250MG CAPSULE / ORAL AB 2011-07-22 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A091322-001 MEFENAMIC ACID 250MG CAPSULE / ORAL AB 2011-07-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091322-001 MEFENAMIC ACID 250MG CAPSULE / ORAL AB 2011-07-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A091322-001 MEFENAMIC ACID 250MG CAPSULE / ORAL AB 2011-07-22 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091322-001 MEFENAMIC ACID 250MG CAPSULE / ORAL AB 2011-07-22 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091322-001 MEFENAMIC ACID 250MG CAPSULE / ORAL AB 2011-07-22 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091322-001 MEFENAMIC ACID 250MG CAPSULE / ORAL AB 2011-07-22 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091322-001 MEFENAMIC ACID 250MG CAPSULE / ORAL AB 2011-07-22 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091322-001 MEFENAMIC ACID 250MG CAPSULE / ORAL AB 2011-07-22 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091322-001 MEFENAMIC ACID 250MG CAPSULE / ORAL AB 2011-07-22 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A091322-001 MEFENAMIC ACID 250MG CAPSULE / ORAL AB 2011-07-22 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091322-001 MEFENAMIC ACID 250MG CAPSULE / ORAL AB 2011-07-22 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A091322-001 MEFENAMIC ACID 250MG CAPSULE / ORAL AB 2011-07-22 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A091322-001 MEFENAMIC ACID 250MG CAPSULE / ORAL AB 2011-07-22 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A091322-001 MEFENAMIC ACID 250MG CAPSULE / ORAL AB 2011-07-22 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A091322-001 MEFENAMIC ACID 250MG CAPSULE / ORAL AB 2011-07-22 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A091322-001 MEFENAMIC ACID 250MG CAPSULE / ORAL AB 2011-07-22 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A091322-001 MEFENAMIC ACID 250MG CAPSULE / ORAL AB 2011-07-22 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A091322-001 MEFENAMIC ACID 250MG CAPSULE / ORAL AB 2011-07-22 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A091322-001 MEFENAMIC ACID 250MG CAPSULE / ORAL AB 2011-07-22 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A091322-001 MEFENAMIC ACID 250MG CAPSULE / ORAL AB 2011-07-22 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A091322-001 MEFENAMIC ACID 250MG CAPSULE / ORAL AB 2011-07-22 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A091322-001 MEFENAMIC ACID 250MG CAPSULE / ORAL AB 2011-07-22 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A091322-001 MEFENAMIC ACID 250MG CAPSULE / ORAL AB 2011-07-22 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A091322-001 MEFENAMIC ACID 250MG CAPSULE / ORAL AB 2011-07-22 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A091322-001 MEFENAMIC ACID 250MG CAPSULE / ORAL AB 2011-07-22 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A091322-001 MEFENAMIC ACID 250MG CAPSULE / ORAL AB 2011-07-22 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A091322-001 MEFENAMIC ACID 250MG CAPSULE / ORAL AB 2011-07-22 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A091322-001 MEFENAMIC ACID 250MG CAPSULE / ORAL AB 2011-07-22 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A091322-001 MEFENAMIC ACID 250MG CAPSULE / ORAL AB 2011-07-22 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A091322-001 MEFENAMIC ACID 250MG CAPSULE / ORAL AB 2011-07-22 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A091322-001 MEFENAMIC ACID 250MG CAPSULE / ORAL AB 2011-07-22 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A091322-001 MEFENAMIC ACID 250MG CAPSULE / ORAL AB 2011-07-22 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A091322-001 MEFENAMIC ACID 250MG CAPSULE / ORAL AB 2011-07-22 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A091322-001 MEFENAMIC ACID 250MG CAPSULE / ORAL AB 2011-07-22 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A091322-001 MEFENAMIC ACID 250MG CAPSULE / ORAL AB 2011-07-22 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A091322-001 MEFENAMIC ACID 250MG CAPSULE / ORAL AB 2011-07-22 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A091322-001 MEFENAMIC ACID 250MG CAPSULE / ORAL AB 2011-07-22 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A091322-001 MEFENAMIC ACID 250MG CAPSULE / ORAL AB 2011-07-22 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A091322-001 MEFENAMIC ACID 250MG CAPSULE / ORAL AB 2011-07-22 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
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.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 80425-0423-1 Mefenamic Acid 30 in 1 BOTTLE CAPSULE 30 1 80425-0423-2 Mefenamic Acid 60 in 1 BOTTLE CAPSULE 60 1 80425-0423-3 Mefenamic Acid 90 in 1 BOTTLE CAPSULE 90 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 80425-0423 MEFENAMIC ACID CAPSULE [ADVANCED RX OF TENNESSEE, LLC] 1 Current NDC, 3 package rows 20240802_1e927779-411a-b5f5-e063-6394a90aae93.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 80425-0423-1 80425042301 30 CAPSULE in 1 BOTTLE (80425-0423-1) 30 capsule 2024-07-19 No No Current 80425-0423-2 80425042302 60 CAPSULE in 1 BOTTLE (80425-0423-2) 60 capsule 2024-07-19 No No Current 80425-0423-3 80425042303 90 CAPSULE in 1 BOTTLE (80425-0423-3) 90 capsule 2024-07-19 No No Current