Home NDC 0276-0509-30 Mefenamic Acid
Product NDC 0276-0509
Requested package NDC 0276-0509-30
11-digit product format 002760509
Labeler code 0276
Product ID 0276-0509_4bc27dd6-5112-b6c1-e063-6394a90a5ed4
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Mefenamic Acid
Dosage form CAPSULE
Route ORAL
Labeler Misemer Pharmaceuticals, Inc
Application ANDA091608
Marketing category ANDA
Marketing start 2021-11-01
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 Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 15 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 1332a3947898…d4bfe170f9cd…
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 A091608-001 MEFENAMIC ACID MEFENAMIC ACID 250MG CAPSULE / ORAL AB 2014-06-02
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A091608-001 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 A091608-001 MEFENAMIC ACID 250MG CAPSULE / ORAL AB 2014-06-02 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A091608-001 MEFENAMIC ACID 250MG CAPSULE / ORAL AB 2014-06-02 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091608-001 MEFENAMIC ACID 250MG CAPSULE / ORAL AB 2014-06-02 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A091608-001 MEFENAMIC ACID 250MG CAPSULE / ORAL AB 2014-06-02 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091608-001 MEFENAMIC ACID 250MG CAPSULE / ORAL AB 2014-06-02 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091608-001 MEFENAMIC ACID 250MG CAPSULE / ORAL AB 2014-06-02 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091608-001 MEFENAMIC ACID 250MG CAPSULE / ORAL AB 2014-06-02 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091608-001 MEFENAMIC ACID 250MG CAPSULE / ORAL AB 2014-06-02 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091608-001 MEFENAMIC ACID 250MG CAPSULE / ORAL AB 2014-06-02 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091608-001 MEFENAMIC ACID 250MG CAPSULE / ORAL AB 2014-06-02 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A091608-001 MEFENAMIC ACID 250MG CAPSULE / ORAL AB 2014-06-02 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091608-001 MEFENAMIC ACID 250MG CAPSULE / ORAL AB 2014-06-02 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A091608-001 MEFENAMIC ACID 250MG CAPSULE / ORAL AB 2014-06-02 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A091608-001 MEFENAMIC ACID 250MG CAPSULE / ORAL AB 2014-06-02 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A091608-001 MEFENAMIC ACID 250MG CAPSULE / ORAL AB 2014-06-02 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A091608-001 MEFENAMIC ACID 250MG CAPSULE / ORAL AB 2014-06-02 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A091608-001 MEFENAMIC ACID 250MG CAPSULE / ORAL AB 2014-06-02 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A091608-001 MEFENAMIC ACID 250MG CAPSULE / ORAL AB 2014-06-02 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A091608-001 MEFENAMIC ACID 250MG CAPSULE / ORAL AB 2014-06-02 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A091608-001 MEFENAMIC ACID 250MG CAPSULE / ORAL AB 2014-06-02 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A091608-001 MEFENAMIC ACID 250MG CAPSULE / ORAL AB 2014-06-02 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A091608-001 MEFENAMIC ACID 250MG CAPSULE / ORAL AB 2014-06-02 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A091608-001 MEFENAMIC ACID 250MG CAPSULE / ORAL AB 2014-06-02 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A091608-001 MEFENAMIC ACID 250MG CAPSULE / ORAL AB 2014-06-02 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A091608-001 MEFENAMIC ACID 250MG CAPSULE / ORAL AB 2014-06-02 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A091608-001 MEFENAMIC ACID 250MG CAPSULE / ORAL AB 2014-06-02 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A091608-001 MEFENAMIC ACID 250MG CAPSULE / ORAL AB 2014-06-02 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A091608-001 MEFENAMIC ACID 250MG CAPSULE / ORAL AB 2014-06-02 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A091608-001 MEFENAMIC ACID 250MG CAPSULE / ORAL AB 2014-06-02 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A091608-001 MEFENAMIC ACID 250MG CAPSULE / ORAL AB 2014-06-02 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A091608-001 MEFENAMIC ACID 250MG CAPSULE / ORAL AB 2014-06-02 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A091608-001 MEFENAMIC ACID 250MG CAPSULE / ORAL AB 2014-06-02 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A091608-001 MEFENAMIC ACID 250MG CAPSULE / ORAL AB 2014-06-02 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A091608-001 MEFENAMIC ACID 250MG CAPSULE / ORAL AB 2014-06-02 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A091608-001 MEFENAMIC ACID 250MG CAPSULE / ORAL AB 2014-06-02 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A091608-001 MEFENAMIC ACID 250MG CAPSULE / ORAL AB 2014-06-02 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A091608-001 MEFENAMIC ACID 250MG CAPSULE / ORAL AB 2014-06-02 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A091608-001 MEFENAMIC ACID 250MG CAPSULE / ORAL AB 2014-06-02 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A091608-001 MEFENAMIC ACID 250MG CAPSULE / ORAL AB 2014-06-02 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A091608-001 MEFENAMIC ACID 250MG CAPSULE / ORAL AB 2014-06-02 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 2027-12-31 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# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0276-0509-30 Mefenamic Acid 30 in 1 BOTTLE CAPSULE 30 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0276-0509 MEFENAMIC ACID CAPSULE [MISEMER PHARMACEUTICALS, INC] 2 Current NDC, Legacy NDC, 1 package rows 20221217_d0291319-ab3e-20c8-e053-2a95a90afabb.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 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0276-0509-30 00276050930 30 CAPSULE in 1 BOTTLE (0276-0509-30) 30 capsule 2021-11-01 0000-00-00 No No Current