Home NDC 53489-478-05 SULINDAC
Product NDC 53489-478
Requested package NDC 53489-478-05
11-digit product format 534890478
Labeler code 53489
Product ID 53489-478_2524fd49-5789-e388-e063-6394a90a2c9b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name sulindac
Dosage form TABLET
Route ORAL
Labeler Sun Pharmaceutical Industries, Inc.
Application ANDA072050
Marketing category ANDA
Marketing start 2009-09-04
Substance SULINDAC
Active strength 150 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 1 .
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 A072050-001 SULINDAC SULINDAC 150MG 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 A072050-001 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 · 41 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 2026-02-19 14:30 UTC 2026-02 A072050-001 SULINDAC 150MG TABLET / ORAL AB 1991-04-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A072050-001 SULINDAC 150MG TABLET / ORAL AB 1991-04-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A072050-001 SULINDAC 150MG TABLET / ORAL AB 1991-04-17 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A072050-001 SULINDAC 150MG TABLET / ORAL AB 1991-04-17 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A072050-001 SULINDAC 150MG TABLET / ORAL AB 1991-04-17 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A072050-001 SULINDAC 150MG TABLET / ORAL AB 1991-04-17 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A072050-001 SULINDAC 150MG TABLET / ORAL AB 1991-04-17 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A072050-001 SULINDAC 150MG TABLET / ORAL AB 1991-04-17 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A072050-001 SULINDAC 150MG TABLET / ORAL AB 1991-04-17 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A072050-001 SULINDAC 150MG TABLET / ORAL AB 1991-04-17 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A072050-001 SULINDAC 150MG TABLET / ORAL AB 1991-04-17 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A072050-001 SULINDAC 150MG TABLET / ORAL AB 1991-04-17 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A072050-001 SULINDAC 150MG TABLET / ORAL AB 1991-04-17 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A072050-001 SULINDAC 150MG TABLET / ORAL AB 1991-04-17 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A072050-001 SULINDAC 150MG TABLET / ORAL AB 1991-04-17 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A072050-001 SULINDAC 150MG TABLET / ORAL AB 1991-04-17 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A072050-001 SULINDAC 150MG TABLET / ORAL AB 1991-04-17 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A072050-001 SULINDAC 150MG TABLET / ORAL AB 1991-04-17 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A072050-001 SULINDAC 150MG TABLET / ORAL AB 1991-04-17 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A072050-001 SULINDAC 150MG TABLET / ORAL AB 1991-04-17 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A072050-001 SULINDAC 150MG TABLET / ORAL AB 1991-04-17 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A072050-001 SULINDAC 150MG TABLET / ORAL AB 1991-04-17 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A072050-001 SULINDAC 150MG TABLET / ORAL AB 1991-04-17 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A072050-001 SULINDAC 150MG TABLET / ORAL AB 1991-04-17 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A072050-001 SULINDAC 150MG TABLET / ORAL AB 1991-04-17 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A072050-001 SULINDAC 150MG TABLET / ORAL AB 1991-04-17 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A072050-001 SULINDAC 150MG TABLET / ORAL AB 1991-04-17 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A072050-001 SULINDAC 150MG TABLET / ORAL AB 1991-04-17 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A072050-001 SULINDAC 150MG TABLET / ORAL AB 1991-04-17 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A072050-001 SULINDAC 150MG TABLET / ORAL AB 1991-04-17 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A072050-001 SULINDAC 150MG TABLET / ORAL AB 1991-04-17 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A072050-001 SULINDAC 150MG TABLET / ORAL AB 1991-04-17 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A072050-001 SULINDAC 150MG TABLET / ORAL AB 1991-04-17 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A072050-001 SULINDAC 150MG TABLET / ORAL AB 1991-04-17 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A072050-001 SULINDAC 150MG TABLET / ORAL AB 1991-04-17 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A072050-001 SULINDAC 150MG TABLET / ORAL AB 1991-04-17 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A072050-001 SULINDAC 150MG TABLET / ORAL AB 1991-04-17 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A072050-001 SULINDAC 150MG TABLET / ORAL AB 1991-04-17 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A072050-001 SULINDAC 150MG TABLET / ORAL AB 1991-04-17 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A072050-001 SULINDAC 150MG TABLET / ORAL AB 1991-04-17 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 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 150 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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 198238 Internal RxNorm lookup 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 53489-478-01 SULINDAC 100 in 1 BOTTLE, PLASTIC TABLET 100 16 53489-478-02 SULINDAC 50 in 1 BOTTLE, PLASTIC TABLET 50 16 53489-478-03 SULINDAC 250 in 1 BOTTLE, PLASTIC TABLET 250 16 53489-478-05 SULINDAC 500 in 1 BOTTLE, PLASTIC TABLET 500 16 53489-478-06 SULINDAC 60 in 1 BOTTLE, PLASTIC TABLET 60 16 53489-478-10 SULINDAC 1000 in 1 BOTTLE, PLASTIC TABLET 1000 16
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 53489-478 SULINDAC TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.] 16 Current NDC, Legacy NDC, 6 package rows 20241025_a47e4259-d44b-4b7b-b517-841cb6840982.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 Units Marketing start Marketing end Sample Exclude flag Status 53489-478-05 53489047805 500 TABLET in 1 BOTTLE, PLASTIC (53489-478-05) 500 tablet 2009-09-04 0000-00-00 No No Current