Home NDC 68180-185 Mefenamic Acid
Product NDC 68180-185
11-digit product format 681800185
Labeler code 68180
Product ID 68180-185_3e8cdf69-7610-4745-a6b6-0d3d0af09867
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Mefenamic Acid
Dosage form CAPSULE
Route ORAL
Labeler Lupin Pharmaceuticals, Inc.
Application ANDA091322
Marketing category ANDA
Marketing start 2011-09-06
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 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-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 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# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 68180-185-01 Mefenamic Acid 100 in 1 BOTTLE CAPSULE 100 13 68180-185-06 Mefenamic Acid 30 in 1 BOTTLE CAPSULE 30 13 68180-185-11 Mefenamic Acid 8 in 1 BLISTER PACK CAPSULE 8 13
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68180-185 MEFENAMIC ACID CAPSULE [LUPIN PHARMACEUTICALS, INC.] 8 Current NDC, Legacy NDC, 3 package rows 20240120_d15733a9-d5fd-4d5f-86ce-e7ed8c706c7f.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 Marketing end Sample Exclude flag Status 68180-185-01 68180018501 100 CAPSULE in 1 BOTTLE (68180-185-01) 100 capsule 2011-09-06 0000-00-00 No No Current 68180-185-06 68180018506 30 CAPSULE in 1 BOTTLE (68180-185-06) 30 capsule 2011-09-06 0000-00-00 No No Current 68180-185-11 68180018511 8 in 1 BLISTER PACK Historical 68180-185-13 68180018513 3 BLISTER PACK in 1 CARTON (68180-185-13) > 8 CAPSULE in 1 BLISTER PACK (68180-185-11) 3 blister pack 2011-09-06 0000-00-00 No No Current