Home NDC 16571-825 TOLMETIN SODIUM
Product NDC 16571-825
11-digit product format 165710825
Labeler code 16571
Product ID 16571-825_ff84bf16-f778-489c-9cb0-c6df96b5b56d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name tolmetin sodium
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Rising Pharma Holdings, Inc.
Application ANDA074473
Marketing category ANDA
Marketing start 2023-04-11
Marketing end 2026-05-31
Substance TOLMETIN SODIUM
Active strength 600 mg/1
Pharmacologic classes Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag No
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 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 Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 16571-825-09 TOLMETIN SODIUM 90 in 1 BOTTLE TABLET, FILM COATED 90 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 16571-825 TOLMETIN SODIUM TABLET, FILM COATED [RISING PHARMA HOLDINGS, INC.] 4 Current NDC, 1 package rows 20241211_fa4096f0-0d22-4421-b4ca-6b1d7f078bd3.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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 16571-825-09 16571082509 90 TABLET, FILM COATED in 1 BOTTLE (16571-825-09) 2023-04-11 2026-05-31 No No Historical