Home NDC 50991-988 Tolectin
Product NDC 50991-988
11-digit product format 509910988
Labeler code 50991
Product ID 50991-988_472dd96d-50bb-e82c-e063-6294a90af66d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name tolmetin sodium
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Poly Pharmaceuticals, Inc.
Application ANDA074473
Marketing category ANDA
Marketing start 2024-04-04
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
Listing certified through 2026-12-31
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 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…
Additional Listing Data#
Finished product Yes
Brand name base Tolectin
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TOLMETIN SODIUM 600 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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 198297 Internal RxNorm lookup 208048 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 50991-988-30 Tolectin 30 in 1 BOTTLE TABLET, FILM COATED 30 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50991-988 TOLECTIN (TOLMETIN SODIUM) TABLET, FILM COATED [POLY PHARMACEUTICALS, INC.] 1 Current NDC, 1 package rows 20240418_15467b19-e43a-5be9-e063-6294a90a3cca.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 Marketing start Sample Exclude flag Status 50991-988-30 50991098830 30 TABLET, FILM COATED in 1 BOTTLE (50991-988-30) 2024-04-04 No No Current