Home NDC 0904-7335 SULINDAC
Product NDC 0904-7335
11-digit product format 009047335
Labeler code 0904
Product ID 0904-7335_ff631d39-5057-492d-90a4-32e4999b06de
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name sulindac
Dosage form TABLET
Route ORAL
Labeler Major Pharmaceuticals
Application ANDA072051
Marketing category ANDA
Marketing start 2023-07-27
Marketing end 2026-07-31
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
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.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0904-7335-60 SULINDAC 100 in 1 BOTTLE, PLASTIC TABLET 100 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0904-7335 SULINDAC TABLET [MAJOR PHARMACEUTICALS] 3 Current NDC, 1 package rows 20250227_41c7882e-530a-4ac1-8de4-8d1e7b391467.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 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 Marketing end Sample Exclude flag Status 0904-7335-60 00904733560 100 TABLET in 1 BOTTLE, PLASTIC (0904-7335-60) 100 tablet 2023-07-27 2026-07-31 No No Historical