Home NDC 61825-310 TOLMETIN SODIUM
Product NDC 61825-310
11-digit product format 618250310
Labeler code 61825
Product ID 61825-310_4d9de430-f193-a927-e063-6294a90a14d4
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name TOLMETIN SODIUM
Dosage form CAPSULE
Route ORAL
Labeler Galt Pharmaceuticals, LLC
Application ANDA073393
Marketing category ANDA
Marketing start 2026-03-19
Substance TOLMETIN SODIUM
Active strength 400 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 A073393-001 TOLMETIN SODIUM TOLMETIN SODIUM EQ 400MG BASE CAPSULE / ORAL RS 1993-05-27
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 A073393-001 TOLMETIN SODIUM EQ 400MG BASE CAPSULE / ORAL RS 1993-05-27 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A073393-001 TOLMETIN SODIUM EQ 400MG BASE CAPSULE / ORAL RS 1993-05-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A073393-001 TOLMETIN SODIUM EQ 400MG BASE CAPSULE / ORAL RS 1993-05-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A073393-001 TOLMETIN SODIUM EQ 400MG BASE CAPSULE / ORAL RS 1993-05-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A073393-001 TOLMETIN SODIUM EQ 400MG BASE CAPSULE / ORAL RS 1993-05-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A073393-001 TOLMETIN SODIUM EQ 400MG BASE CAPSULE / ORAL RS 1993-05-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A073393-001 TOLMETIN SODIUM EQ 400MG BASE CAPSULE / ORAL RS 1993-05-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A073393-001 TOLMETIN SODIUM EQ 400MG BASE CAPSULE / ORAL RS 1993-05-27 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A073393-001 TOLMETIN SODIUM EQ 400MG BASE CAPSULE / ORAL 1993-05-27 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A073393-001 TOLMETIN SODIUM EQ 400MG BASE CAPSULE / ORAL RS 1993-05-27 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A073393-001 TOLMETIN SODIUM EQ 400MG BASE CAPSULE / ORAL 1993-05-27 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A073393-001 TOLMETIN SODIUM EQ 400MG BASE CAPSULE / ORAL 1993-05-27 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A073393-001 TOLMETIN SODIUM EQ 400MG BASE CAPSULE / ORAL 1993-05-27 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A073393-001 TOLMETIN SODIUM EQ 400MG BASE CAPSULE / ORAL 1993-05-27 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A073393-001 TOLMETIN SODIUM EQ 400MG BASE CAPSULE / ORAL 1993-05-27 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A073393-001 TOLMETIN SODIUM EQ 400MG BASE CAPSULE / ORAL 1993-05-27 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A073393-001 TOLMETIN SODIUM EQ 400MG BASE CAPSULE / ORAL 1993-05-27 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A073393-001 TOLMETIN SODIUM EQ 400MG BASE CAPSULE / ORAL 1993-05-27 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A073393-001 TOLMETIN SODIUM EQ 400MG BASE CAPSULE / ORAL AB 1993-05-27 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A073393-001 TOLMETIN SODIUM EQ 400MG BASE CAPSULE / ORAL 1993-05-27 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A073393-001 TOLMETIN SODIUM EQ 400MG BASE CAPSULE / ORAL 1993-05-27 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A073393-001 TOLMETIN SODIUM EQ 400MG BASE CAPSULE / ORAL AB 1993-05-27 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A073393-001 TOLMETIN SODIUM EQ 400MG BASE CAPSULE / ORAL AB 1993-05-27 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A073393-001 TOLMETIN SODIUM EQ 400MG BASE CAPSULE / ORAL AB 1993-05-27 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A073393-001 TOLMETIN SODIUM EQ 400MG BASE CAPSULE / ORAL AB 1993-05-27 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A073393-001 TOLMETIN SODIUM EQ 400MG BASE CAPSULE / ORAL AB 1993-05-27 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A073393-001 TOLMETIN SODIUM EQ 400MG BASE CAPSULE / ORAL AB 1993-05-27 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A073393-001 TOLMETIN SODIUM EQ 400MG BASE CAPSULE / ORAL AB 1993-05-27 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A073393-001 TOLMETIN SODIUM EQ 400MG BASE CAPSULE / ORAL 1993-05-27 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A073393-001 TOLMETIN SODIUM EQ 400MG BASE CAPSULE / ORAL 1993-05-27 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A073393-001 TOLMETIN SODIUM EQ 400MG BASE CAPSULE / ORAL 1993-05-27 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A073393-001 TOLMETIN SODIUM EQ 400MG BASE CAPSULE / ORAL 1993-05-27 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A073393-001 TOLMETIN SODIUM EQ 400MG BASE CAPSULE / ORAL 1993-05-27 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A073393-001 TOLMETIN SODIUM EQ 400MG BASE CAPSULE / ORAL 1993-05-27 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A073393-001 TOLMETIN SODIUM EQ 400MG BASE CAPSULE / ORAL 1993-05-27 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A073393-001 TOLMETIN SODIUM EQ 400MG BASE CAPSULE / ORAL 1993-05-27 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A073393-001 TOLMETIN SODIUM EQ 400MG BASE CAPSULE / ORAL 1993-05-27 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A073393-001 TOLMETIN SODIUM EQ 400MG BASE CAPSULE / ORAL 1993-05-27 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A073393-001 TOLMETIN SODIUM EQ 400MG BASE CAPSULE / ORAL 1993-05-27 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A073393-001 TOLMETIN SODIUM EQ 400MG BASE CAPSULE / ORAL 1993-05-27 e64feba35796…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base TOLMETIN SODIUM
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TOLMETIN SODIUM 400 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 02N1TZF99F Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 198296 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 61825-310-30 TOLMETIN SODIUM 30 in 1 BOTTLE CAPSULE 30 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 Units Marketing start Sample Exclude flag Status 61825-310-30 61825031030 30 CAPSULE in 1 BOTTLE (61825-310-30) 30 capsule 2026-03-19 No No Current