Home NDC 62250-677 Mefenamic Acid
Product NDC 62250-677
11-digit product format 622500677
Labeler code 62250
Product ID 62250-677_efd14c7e-b718-21e3-e053-2a95a90a86e5
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Mefenamic Acid
Dosage form CAPSULE
Route ORAL
Labeler Belcher Pharmaceuticals,LLC
Application ANDA091608
Marketing category ANDA
Marketing start 2015-06-25
Marketing end 0000-00-00
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 2023-12-31
Current FDA listing Historical FDA.report record 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 · 4 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 62250-677-30 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 62250-677-30 f5e01cc5f278…a2eaf40c39c3…
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.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded MEFENAMIC ACID ACTIVE INGREDIENT 367589PJ2C MEFENAMIC ACID CAPSULE [BELCHER PHARMACEUTICALS,LLC] 1 MEFENAMIC ACID ACTIVE MOIETY 367589PJ2C MEFENAMIC ACID CAPSULE [BELCHER PHARMACEUTICALS,LLC] 1 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G MEFENAMIC ACID CAPSULE [BELCHER PHARMACEUTICALS,LLC] 1 DIMETHICONE INACTIVE INGREDIENT 92RU3N3Y1O MEFENAMIC ACID CAPSULE [BELCHER PHARMACEUTICALS,LLC] 1 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD MEFENAMIC ACID CAPSULE [BELCHER PHARMACEUTICALS,LLC] 1 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 MEFENAMIC ACID CAPSULE [BELCHER PHARMACEUTICALS,LLC] 1 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT MEFENAMIC ACID CAPSULE [BELCHER PHARMACEUTICALS,LLC] 1 GELATIN INACTIVE INGREDIENT 2G86QN327L MEFENAMIC ACID CAPSULE [BELCHER PHARMACEUTICALS,LLC] 1 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X MEFENAMIC ACID CAPSULE [BELCHER PHARMACEUTICALS,LLC] 1 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 MEFENAMIC ACID CAPSULE [BELCHER PHARMACEUTICALS,LLC] 1 SHELLAC INACTIVE INGREDIENT 46N107B71O MEFENAMIC ACID CAPSULE [BELCHER PHARMACEUTICALS,LLC] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP MEFENAMIC ACID CAPSULE [BELCHER PHARMACEUTICALS,LLC] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 62250-677 MEFENAMIC ACID CAPSULE [BELCHER PHARMACEUTICALS,LLC] 7 Legacy NDC 20231006_4c275df4-f044-4867-8498-f46d34103bbb.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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Mefenamic Acid MEFENAMIC ACID Misemer Pharmaceuticals, Inc d0291319-ab3e-20c8-e053-2a95a90afabb 2026-02-26 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 091608 application number: ANDA091608
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 62250-677-30 62250067730 30 CAPSULE in 1 BOTTLE (62250-677-30) 30 capsule 2015-06-25 0000-00-00 No No Current