Home NDC 0378-0313 Tolmetin Sodium
Product NDC 0378-0313
11-digit product format 003780313
Labeler code 0378
Product ID 0378-0313_b172e608-09ec-447f-bee4-d7c74e46420d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name tolmetin sodium
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Mylan Pharmaceuticals Inc.
Application ANDA074473
Marketing category ANDA
Marketing start 1994-08-30
Marketing end 0000-00-00
Substance TOLMETIN SODIUM
Active strength 600 mg/1
Pharmacologic classes Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag No
Listing certified through 2022-12-31
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 · 24 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 0378-0313-01 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 0378-0313-01 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 0378-0313-01 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 0378-0313-01 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 0378-0313-01 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 0378-0313-01 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 0378-0313-01 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 0378-0313-01 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 0378-0313-01 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 0378-0313-01 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 0378-0313-01 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 0378-0313-01 557ba5c1ecfa…9c80585c8c6e…
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 A074473-001 TOLMETIN SODIUM TOLMETIN SODIUM EQ 600MG BASE TABLET / ORAL RS 1994-08-30
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 A074473-001 TOLMETIN SODIUM EQ 600MG BASE TABLET / ORAL RS 1994-08-30 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A074473-001 TOLMETIN SODIUM EQ 600MG BASE TABLET / ORAL RS 1994-08-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074473-001 TOLMETIN SODIUM EQ 600MG BASE TABLET / ORAL RS 1994-08-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A074473-001 TOLMETIN SODIUM EQ 600MG BASE TABLET / ORAL RS 1994-08-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074473-001 TOLMETIN SODIUM EQ 600MG BASE TABLET / ORAL RS 1994-08-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074473-001 TOLMETIN SODIUM EQ 600MG BASE TABLET / ORAL RS 1994-08-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074473-001 TOLMETIN SODIUM EQ 600MG BASE TABLET / ORAL RS 1994-08-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074473-001 TOLMETIN SODIUM EQ 600MG BASE TABLET / ORAL RS 1994-08-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A074473-001 TOLMETIN SODIUM EQ 600MG BASE TABLET / ORAL RS 1994-08-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A074473-001 TOLMETIN SODIUM EQ 600MG BASE TABLET / ORAL RS 1994-08-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A074473-001 TOLMETIN SODIUM EQ 600MG BASE TABLET / ORAL RS 1994-08-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A074473-001 TOLMETIN SODIUM EQ 600MG BASE TABLET / ORAL RS 1994-08-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A074473-001 TOLMETIN SODIUM EQ 600MG BASE TABLET / ORAL RS 1994-08-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A074473-001 TOLMETIN SODIUM EQ 600MG BASE TABLET / ORAL RS 1994-08-30 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A074473-001 TOLMETIN SODIUM EQ 600MG BASE TABLET / ORAL RS 1994-08-30 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A074473-001 TOLMETIN SODIUM EQ 600MG BASE TABLET / ORAL 1994-08-30 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A074473-001 TOLMETIN SODIUM EQ 600MG BASE TABLET / ORAL 1994-08-30 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A074473-001 TOLMETIN SODIUM EQ 600MG BASE TABLET / ORAL 1994-08-30 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A074473-001 TOLMETIN SODIUM EQ 600MG BASE TABLET / ORAL RS 1994-08-30 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A074473-001 TOLMETIN SODIUM EQ 600MG BASE TABLET / ORAL 1994-08-30 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A074473-001 TOLMETIN SODIUM EQ 600MG BASE TABLET / ORAL 1994-08-30 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A074473-001 TOLMETIN SODIUM EQ 600MG BASE TABLET / ORAL RS 1994-08-30 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A074473-001 TOLMETIN SODIUM EQ 600MG BASE TABLET / ORAL RS 1994-08-30 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A074473-001 TOLMETIN SODIUM EQ 600MG BASE TABLET / ORAL RS 1994-08-30 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A074473-001 TOLMETIN SODIUM EQ 600MG BASE TABLET / ORAL RS 1994-08-30 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A074473-001 TOLMETIN SODIUM EQ 600MG BASE TABLET / ORAL RS 1994-08-30 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A074473-001 TOLMETIN SODIUM EQ 600MG BASE TABLET / ORAL RS 1994-08-30 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A074473-001 TOLMETIN SODIUM EQ 600MG BASE TABLET / ORAL RS 1994-08-30 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A074473-001 TOLMETIN SODIUM EQ 600MG BASE TABLET / ORAL RS 1994-08-30 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A074473-001 TOLMETIN SODIUM EQ 600MG BASE TABLET / ORAL RS 1994-08-30 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A074473-001 TOLMETIN SODIUM EQ 600MG BASE TABLET / ORAL RS 1994-08-30 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A074473-001 TOLMETIN SODIUM EQ 600MG BASE TABLET / ORAL RS 1994-08-30 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A074473-001 TOLMETIN SODIUM EQ 600MG BASE TABLET / ORAL RS 1994-08-30 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A074473-001 TOLMETIN SODIUM EQ 600MG BASE TABLET / ORAL RS 1994-08-30 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A074473-001 TOLMETIN SODIUM EQ 600MG BASE TABLET / ORAL RS 1994-08-30 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A074473-001 TOLMETIN SODIUM EQ 600MG BASE TABLET / ORAL 1994-08-30 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A074473-001 TOLMETIN SODIUM EQ 600MG BASE TABLET / ORAL 1994-08-30 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A074473-001 TOLMETIN SODIUM EQ 600MG BASE TABLET / ORAL 1994-08-30 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A074473-001 TOLMETIN SODIUM EQ 600MG BASE TABLET / ORAL 1994-08-30 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A074473-001 TOLMETIN SODIUM EQ 600MG BASE TABLET / ORAL 1994-08-30 e64feba35796…
DailyMed Product Concepts# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded TOLMETIN SODIUM ACTIVE INGREDIENT 02N1TZF99F TOLMETIN SODIUM TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 5 TOLMETIN ACTIVE MOIETY D8K2JPN18B TOLMETIN SODIUM TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 5 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U TOLMETIN SODIUM TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 5 CROSPOVIDONE INACTIVE INGREDIENT 68401960MK TOLMETIN SODIUM TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 5 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT TOLMETIN SODIUM TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 5 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 TOLMETIN SODIUM TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 5 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO TOLMETIN SODIUM TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 5 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 TOLMETIN SODIUM TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 5 POLYDEXTROSE INACTIVE INGREDIENT VH2XOU12IE TOLMETIN SODIUM TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 5 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A TOLMETIN SODIUM TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 5 POVIDONES INACTIVE INGREDIENT FZ989GH94E TOLMETIN SODIUM TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 5 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J TOLMETIN SODIUM TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 5 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ TOLMETIN SODIUM TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 5 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP TOLMETIN SODIUM TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 5 TRIACETIN INACTIVE INGREDIENT XHX3C3X673 TOLMETIN SODIUM TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 5 TOLMETIN SODIUM ACTIVE INGREDIENT 02N1TZF99F TOLMETIN SODIUM TABLET, FILM COATED [STAT RX USA LLC] 1 TOLMETIN ACTIVE MOIETY D8K2JPN18B TOLMETIN SODIUM TABLET, FILM COATED [STAT RX USA LLC] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U TOLMETIN SODIUM TABLET, FILM COATED [STAT RX USA LLC] 1 CROSPOVIDONE INACTIVE INGREDIENT 68401960MK TOLMETIN SODIUM TABLET, FILM COATED [STAT RX USA LLC] 1 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT TOLMETIN SODIUM TABLET, FILM COATED [STAT RX USA LLC] 1 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 TOLMETIN SODIUM TABLET, FILM COATED [STAT RX USA LLC] 1 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO TOLMETIN SODIUM TABLET, FILM COATED [STAT RX USA LLC] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 TOLMETIN SODIUM TABLET, FILM COATED [STAT RX USA LLC] 1 POLYDEXTROSE INACTIVE INGREDIENT VH2XOU12IE TOLMETIN SODIUM TABLET, FILM COATED [STAT RX USA LLC] 1 POLYETHYLENE GLYCOL INACTIVE INGREDIENT 3WJQ0SDW1A TOLMETIN SODIUM TABLET, FILM COATED [STAT RX USA LLC] 1 POVIDONE INACTIVE INGREDIENT FZ989GH94E TOLMETIN SODIUM TABLET, FILM COATED [STAT RX USA LLC] 1 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J TOLMETIN SODIUM TABLET, FILM COATED [STAT RX USA LLC] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ TOLMETIN SODIUM TABLET, FILM COATED [STAT RX USA LLC] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP TOLMETIN SODIUM TABLET, FILM COATED [STAT RX USA LLC] 1 TRIACETIN INACTIVE INGREDIENT XHX3C3X673 TOLMETIN SODIUM TABLET, FILM COATED [STAT RX USA LLC] 1
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 Marketing start Marketing end Sample Exclude flag Status 0378-0313-01 00378031301 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-0313-01) 1994-08-30 0000-00-00 No No Current