Home NDC 72789-374 SULINDAC
Product NDC 72789-374
11-digit product format 727890374
Labeler code 72789
Product ID 72789-374_31f654da-06fe-9e86-e063-6294a90a3312
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name sulindac
Dosage form TABLET
Route ORAL
Labeler PD-Rx Pharmaceuticals, Inc.
Application ANDA072051
Marketing category ANDA
Marketing start 2009-09-04
Substance SULINDAC
Active strength 200 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 A072051-001 SULINDAC SULINDAC 200MG TABLET / ORAL AB 1991-04-17
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A072051-001 AB
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 A072051-001 SULINDAC 200MG TABLET / ORAL AB 1991-04-17 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A072051-001 SULINDAC 200MG TABLET / ORAL AB 1991-04-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A072051-001 SULINDAC 200MG TABLET / ORAL AB 1991-04-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A072051-001 SULINDAC 200MG TABLET / ORAL AB 1991-04-17 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A072051-001 SULINDAC 200MG TABLET / ORAL AB 1991-04-17 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A072051-001 SULINDAC 200MG TABLET / ORAL AB 1991-04-17 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A072051-001 SULINDAC 200MG TABLET / ORAL AB 1991-04-17 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A072051-001 SULINDAC 200MG TABLET / ORAL AB 1991-04-17 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A072051-001 SULINDAC 200MG TABLET / ORAL AB 1991-04-17 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A072051-001 SULINDAC 200MG TABLET / ORAL AB 1991-04-17 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A072051-001 SULINDAC 200MG TABLET / ORAL AB 1991-04-17 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A072051-001 SULINDAC 200MG TABLET / ORAL AB 1991-04-17 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A072051-001 SULINDAC 200MG TABLET / ORAL AB 1991-04-17 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A072051-001 SULINDAC 200MG TABLET / ORAL AB 1991-04-17 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A072051-001 SULINDAC 200MG TABLET / ORAL AB 1991-04-17 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A072051-001 SULINDAC 200MG TABLET / ORAL AB 1991-04-17 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A072051-001 SULINDAC 200MG TABLET / ORAL AB 1991-04-17 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A072051-001 SULINDAC 200MG TABLET / ORAL AB 1991-04-17 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A072051-001 SULINDAC 200MG TABLET / ORAL AB 1991-04-17 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A072051-001 SULINDAC 200MG TABLET / ORAL AB 1991-04-17 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A072051-001 SULINDAC 200MG TABLET / ORAL AB 1991-04-17 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A072051-001 SULINDAC 200MG TABLET / ORAL AB 1991-04-17 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A072051-001 SULINDAC 200MG TABLET / ORAL AB 1991-04-17 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A072051-001 SULINDAC 200MG TABLET / ORAL AB 1991-04-17 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A072051-001 SULINDAC 200MG TABLET / ORAL AB 1991-04-17 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A072051-001 SULINDAC 200MG TABLET / ORAL AB 1991-04-17 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A072051-001 SULINDAC 200MG TABLET / ORAL AB 1991-04-17 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A072051-001 SULINDAC 200MG TABLET / ORAL AB 1991-04-17 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A072051-001 SULINDAC 200MG TABLET / ORAL AB 1991-04-17 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A072051-001 SULINDAC 200MG TABLET / ORAL AB 1991-04-17 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A072051-001 SULINDAC 200MG TABLET / ORAL AB 1991-04-17 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A072051-001 SULINDAC 200MG TABLET / ORAL AB 1991-04-17 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A072051-001 SULINDAC 200MG TABLET / ORAL AB 1991-04-17 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A072051-001 SULINDAC 200MG TABLET / ORAL AB 1991-04-17 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A072051-001 SULINDAC 200MG TABLET / ORAL AB 1991-04-17 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A072051-001 SULINDAC 200MG TABLET / ORAL AB 1991-04-17 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A072051-001 SULINDAC 200MG TABLET / ORAL AB 1991-04-17 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A072051-001 SULINDAC 200MG TABLET / ORAL AB 1991-04-17 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A072051-001 SULINDAC 200MG TABLET / ORAL AB 1991-04-17 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A072051-001 SULINDAC 200MG TABLET / ORAL AB 1991-04-17 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
Additional Listing Data#
Finished product Yes
Brand name base SULINDAC
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SULINDAC 200 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 184SNS8VUH Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 198239 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 72789-374-01 SULINDAC 100 in 1 BOTTLE, PLASTIC TABLET 100 22 72789-374-82 SULINDAC 500 in 1 BOTTLE, PLASTIC TABLET 500 22
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 72789-374 SULINDAC TABLET [PD-RX PHARMACEUTICALS, INC.] 22 Current NDC, 2 package rows 20250406_1fffe88d-50c8-45cf-ac7c-a62b665c89a8.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 · 3 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join SULINDAC SULINDAC A-S Medication Solutions f4985b1b-7e2c-4911-897a-94c337794bab 2026-03-19 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 072051 application number: ANDA072051 SULINDAC SULINDAC PD-Rx Pharmaceuticals, Inc. 1fffe88d-50c8-45cf-ac7c-a62b665c89a8 2025-04-04 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 072051 application number: ANDA072051 ndc (product): 72789-374 SULINDAC SULINDAC Sun Pharmaceutical Industries, Inc. a47e4259-d44b-4b7b-b517-841cb6840982 2024-10-23 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 072051 application number: ANDA072051
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 72789-374-01 72789037401 100 TABLET in 1 BOTTLE, PLASTIC (72789-374-01) 100 tablet 2024-08-27 No No Current 72789-374-82 72789037482 500 TABLET in 1 BOTTLE, PLASTIC (72789-374-82) 500 tablet 2024-01-25 No No Current