Home NDC 53489-479-01 SULINDAC
Product NDC 53489-479
Requested package NDC 53489-479-01
11-digit product format 534890479
Labeler code 53489
Product ID 53489-479_2524fd49-5789-e388-e063-6394a90a2c9b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name sulindac
Dosage form TABLET
Route ORAL
Labeler Sun Pharmaceutical Industries, 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 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 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 · 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 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…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A072051-001 SULINDAC 200MG 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 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 · 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 53489-479-01 SULINDAC 100 in 1 BOTTLE, PLASTIC TABLET 100 16 53489-479-02 SULINDAC 50 in 1 BOTTLE, PLASTIC TABLET 50 16 53489-479-03 SULINDAC 250 in 1 BOTTLE, PLASTIC TABLET 250 16 53489-479-05 SULINDAC 500 in 1 BOTTLE, PLASTIC TABLET 500 16 53489-479-06 SULINDAC 60 in 1 BOTTLE, PLASTIC TABLET 60 16 53489-479-10 SULINDAC 1000 in 1 BOTTLE, PLASTIC TABLET 1000 16
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded sulindac ACTIVE INGREDIENT 184SNS8VUH SULINDAC TABLET [MUTUAL PHARMACEUTICAL COMPANY, INC.] 10 sulindac ACTIVE MOIETY 184SNS8VUH SULINDAC TABLET [MUTUAL PHARMACEUTICAL COMPANY, INC.] 10 cellulose, microcrystalline INACTIVE INGREDIENT OP1R32D61U SULINDAC TABLET [MUTUAL PHARMACEUTICAL COMPANY, INC.] 10 magnesium stearate INACTIVE INGREDIENT 70097M6I30 SULINDAC TABLET [MUTUAL PHARMACEUTICAL COMPANY, INC.] 10 starch, corn INACTIVE INGREDIENT O8232NY3SJ SULINDAC TABLET [MUTUAL PHARMACEUTICAL COMPANY, INC.] 10 MINOCYCLINE HYDROCHLORIDE ACTIVE INGREDIENT 0020414E5U MINOCYCLINE HYDROCHLORIDE CAPSULE [DIRECT RX] 1 SULINDAC ACTIVE INGREDIENT 184SNS8VUH SULINDAC TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 MINOCYCLINE ACTIVE MOIETY FYY3R43WGO MINOCYCLINE HYDROCHLORIDE CAPSULE [DIRECT RX] 1 sulindac ACTIVE MOIETY 184SNS8VUH SULINDAC TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 ALCOHOL INACTIVE INGREDIENT 3K9958V90M MINOCYCLINE HYDROCHLORIDE CAPSULE [DIRECT RX] 1 AMMONIA INACTIVE INGREDIENT 5138Q19F1X MINOCYCLINE HYDROCHLORIDE CAPSULE [DIRECT RX] 1 BUTYL ALCOHOL INACTIVE INGREDIENT 8PJ61P6TS3 MINOCYCLINE HYDROCHLORIDE CAPSULE [DIRECT RX] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U SULINDAC TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 D&C RED NO. 28 INACTIVE INGREDIENT 767IP0Y5NH MINOCYCLINE HYDROCHLORIDE CAPSULE [DIRECT RX] 1 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD MINOCYCLINE HYDROCHLORIDE CAPSULE [DIRECT RX] 1 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA MINOCYCLINE HYDROCHLORIDE CAPSULE [DIRECT RX] 1 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 MINOCYCLINE HYDROCHLORIDE CAPSULE [DIRECT RX] 1 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 MINOCYCLINE HYDROCHLORIDE CAPSULE [DIRECT RX] 1 GELATIN INACTIVE INGREDIENT 2G86QN327L MINOCYCLINE HYDROCHLORIDE CAPSULE [DIRECT RX] 1 ISOPROPYL ALCOHOL INACTIVE INGREDIENT ND2M416302 MINOCYCLINE HYDROCHLORIDE CAPSULE [DIRECT RX] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 SULINDAC TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 MINOCYCLINE HYDROCHLORIDE CAPSULE [DIRECT RX] 1 POTASSIUM HYDROXIDE INACTIVE INGREDIENT WZH3C48M4T MINOCYCLINE HYDROCHLORIDE CAPSULE [DIRECT RX] 1 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 MINOCYCLINE HYDROCHLORIDE CAPSULE [DIRECT RX] 1 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J MINOCYCLINE HYDROCHLORIDE CAPSULE [DIRECT RX] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ MINOCYCLINE HYDROCHLORIDE CAPSULE [DIRECT RX] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ SULINDAC TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP MINOCYCLINE HYDROCHLORIDE CAPSULE [DIRECT RX] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 53489-479 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 · 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 ndc (package): 53489-479-01 ndc (product): 53489-479 ndc11 (package): 53489047901
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 53489-479-01 53489047901 100 TABLET in 1 BOTTLE, PLASTIC (53489-479-01) 100 tablet 2009-09-04 0000-00-00 No No Current