Home NDC 0378-3000-01 Meclofenamate Sodium
Product NDC 0378-3000
Requested package NDC 0378-3000-01
11-digit product format 003783000
Labeler code 0378
Product ID 0378-3000_4be1c27e-b52c-472c-8795-16af910fa26e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name meclofenamate sodium
Dosage form CAPSULE
Route ORAL
Labeler Mylan Pharmaceuticals Inc.
Application ANDA071081
Marketing category ANDA
Marketing start 1986-09-03
Substance MECLOFENAMATE SODIUM
Active strength 100 mg/1
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 43 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A071081-001 MECLOFENAMATE SODIUM MECLOFENAMATE SODIUM EQ 100MG BASE CAPSULE / ORAL RS 1986-09-03 A071081-002 MECLOFENAMATE SODIUM MECLOFENAMATE SODIUM EQ 50MG BASE CAPSULE / ORAL 1986-09-03
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 3 · 86 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 2026-09-14 22:38:34 2026-08 A071081-001 MECLOFENAMATE SODIUM EQ 100MG BASE CAPSULE / ORAL RS 1986-09-03 84e616aacf4f…2026-09-14 22:38:34 2026-08 A071081-002 MECLOFENAMATE SODIUM EQ 50MG BASE CAPSULE / ORAL 1986-09-03 84e616aacf4f…2026-08-18 06:07:40 2026-07 A071081-001 MECLOFENAMATE SODIUM EQ 100MG BASE CAPSULE / ORAL RS 1986-09-03 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A071081-002 MECLOFENAMATE SODIUM EQ 50MG BASE CAPSULE / ORAL 1986-09-03 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A071081-001 MECLOFENAMATE SODIUM EQ 100MG BASE CAPSULE / ORAL RS 1986-09-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A071081-002 MECLOFENAMATE SODIUM EQ 50MG BASE CAPSULE / ORAL 1986-09-03 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A071081-001 MECLOFENAMATE SODIUM EQ 100MG BASE CAPSULE / ORAL RS 1986-09-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A071081-002 MECLOFENAMATE SODIUM EQ 50MG BASE CAPSULE / ORAL 1986-09-03 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A071081-001 MECLOFENAMATE SODIUM EQ 100MG BASE CAPSULE / ORAL RS 1986-09-03 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A071081-002 MECLOFENAMATE SODIUM EQ 50MG BASE CAPSULE / ORAL 1986-09-03 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A071081-001 MECLOFENAMATE SODIUM EQ 100MG BASE CAPSULE / ORAL RS 1986-09-03 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A071081-002 MECLOFENAMATE SODIUM EQ 50MG BASE CAPSULE / ORAL 1986-09-03 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A071081-001 MECLOFENAMATE SODIUM EQ 100MG BASE CAPSULE / ORAL RS 1986-09-03 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A071081-002 MECLOFENAMATE SODIUM EQ 50MG BASE CAPSULE / ORAL 1986-09-03 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A071081-001 MECLOFENAMATE SODIUM EQ 100MG BASE CAPSULE / ORAL RS 1986-09-03 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A071081-002 MECLOFENAMATE SODIUM EQ 50MG BASE CAPSULE / ORAL 1986-09-03 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A071081-001 MECLOFENAMATE SODIUM EQ 100MG BASE CAPSULE / ORAL RS 1986-09-03 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A071081-002 MECLOFENAMATE SODIUM EQ 50MG BASE CAPSULE / ORAL 1986-09-03 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A071081-001 MECLOFENAMATE SODIUM EQ 100MG BASE CAPSULE / ORAL RS 1986-09-03 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A071081-002 MECLOFENAMATE SODIUM EQ 50MG BASE CAPSULE / ORAL 1986-09-03 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A071081-001 MECLOFENAMATE SODIUM EQ 100MG BASE CAPSULE / ORAL RS 1986-09-03 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A071081-002 MECLOFENAMATE SODIUM EQ 50MG BASE CAPSULE / ORAL 1986-09-03 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A071081-001 MECLOFENAMATE SODIUM EQ 100MG BASE CAPSULE / ORAL RS 1986-09-03 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A071081-002 MECLOFENAMATE SODIUM EQ 50MG BASE CAPSULE / ORAL 1986-09-03 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A071081-001 MECLOFENAMATE SODIUM EQ 100MG BASE CAPSULE / ORAL RS 1986-09-03 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A071081-002 MECLOFENAMATE SODIUM EQ 50MG BASE CAPSULE / ORAL 1986-09-03 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A071081-001 MECLOFENAMATE SODIUM EQ 100MG BASE CAPSULE / ORAL RS 1986-09-03 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A071081-002 MECLOFENAMATE SODIUM EQ 50MG BASE CAPSULE / ORAL 1986-09-03 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A071081-001 MECLOFENAMATE SODIUM EQ 100MG BASE CAPSULE / ORAL RS 1986-09-03 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A071081-002 MECLOFENAMATE SODIUM EQ 50MG BASE CAPSULE / ORAL 1986-09-03 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A071081-001 MECLOFENAMATE SODIUM EQ 100MG BASE CAPSULE / ORAL RS 1986-09-03 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A071081-002 MECLOFENAMATE SODIUM EQ 50MG BASE CAPSULE / ORAL 1986-09-03 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A071081-001 MECLOFENAMATE SODIUM EQ 100MG BASE CAPSULE / ORAL RS 1986-09-03 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A071081-002 MECLOFENAMATE SODIUM EQ 50MG BASE CAPSULE / ORAL 1986-09-03 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A071081-001 MECLOFENAMATE SODIUM EQ 100MG BASE CAPSULE / ORAL RS 1986-09-03 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A071081-002 MECLOFENAMATE SODIUM EQ 50MG BASE CAPSULE / ORAL 1986-09-03 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A071081-001 MECLOFENAMATE SODIUM EQ 100MG BASE CAPSULE / ORAL RS 1986-09-03 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A071081-002 MECLOFENAMATE SODIUM EQ 50MG BASE CAPSULE / ORAL 1986-09-03 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A071081-001 MECLOFENAMATE SODIUM EQ 100MG BASE CAPSULE / ORAL RS 1986-09-03 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A071081-002 MECLOFENAMATE SODIUM EQ 50MG BASE CAPSULE / ORAL 1986-09-03 74a2ff9319b5…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Meclofenamate Sodium
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MECLOFENAMATE SODIUM 100 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 94NJ818U2W Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 618552 Internal RxNorm lookup 618557 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 0378-3000-01 Meclofenamate Sodium 100 in 1 BOTTLE, PLASTIC CAPSULE 100 20
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0378-3000 MECLOFENAMATE SODIUM CAPSULE [MYLAN PHARMACEUTICALS INC.] 18 Current NDC, Legacy NDC, 1 package rows 20250117_96f19af4-de8f-4fd7-90d8-55fe6ebdd81d.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 0378-3000-01 00378300001 100 CAPSULE in 1 BOTTLE, PLASTIC (0378-3000-01) 100 capsule 1986-09-03 0000-00-00 No No Current