Home NDC 55289-930-10 Sulindac
Product NDC 55289-930
Requested package NDC 55289-930-10
11-digit product format 552890930
Labeler code 55289
Product ID 55289-930_30ca698c-7fb2-9fa7-e063-6294a90abd86
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Sulindac
Dosage form TABLET
Route ORAL
Labeler PD-Rx Pharmaceuticals, Inc.
Application ANDA071795
Marketing category ANDA
Marketing start 1990-04-03
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 A071795-001 SULINDAC SULINDAC 200MG TABLET / ORAL AB RS 1990-04-03
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A071795-001 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 A071795-001 SULINDAC 200MG TABLET / ORAL AB RS 1990-04-03 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A071795-001 SULINDAC 200MG TABLET / ORAL AB RS 1990-04-03 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A071795-001 SULINDAC 200MG TABLET / ORAL AB RS 1990-04-03 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A071795-001 SULINDAC 200MG TABLET / ORAL AB RS 1990-04-03 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A071795-001 SULINDAC 200MG TABLET / ORAL AB RS 1990-04-03 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A071795-001 SULINDAC 200MG TABLET / ORAL AB RS 1990-04-03 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A071795-001 SULINDAC 200MG TABLET / ORAL AB RS 1990-04-03 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A071795-001 SULINDAC 200MG TABLET / ORAL AB RS 1990-04-03 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A071795-001 SULINDAC 200MG TABLET / ORAL AB RS 1990-04-03 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A071795-001 SULINDAC 200MG TABLET / ORAL AB RS 1990-04-03 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A071795-001 SULINDAC 200MG TABLET / ORAL AB RS 1990-04-03 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A071795-001 SULINDAC 200MG TABLET / ORAL AB RS 1990-04-03 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A071795-001 SULINDAC 200MG TABLET / ORAL AB RS 1990-04-03 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A071795-001 SULINDAC 200MG TABLET / ORAL AB RS 1990-04-03 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A071795-001 SULINDAC 200MG TABLET / ORAL AB RS 1990-04-03 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A071795-001 SULINDAC 200MG TABLET / ORAL AB RS 1990-04-03 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A071795-001 SULINDAC 200MG TABLET / ORAL AB RS 1990-04-03 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A071795-001 SULINDAC 200MG TABLET / ORAL AB RS 1990-04-03 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A071795-001 SULINDAC 200MG TABLET / ORAL AB RS 1990-04-03 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A071795-001 SULINDAC 200MG TABLET / ORAL AB RS 1990-04-03 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A071795-001 SULINDAC 200MG TABLET / ORAL AB RS 1990-04-03 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A071795-001 SULINDAC 200MG TABLET / ORAL AB RS 1990-04-03 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A071795-001 SULINDAC 200MG TABLET / ORAL AB RS 1990-04-03 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A071795-001 SULINDAC 200MG TABLET / ORAL AB RS 1990-04-03 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A071795-001 SULINDAC 200MG TABLET / ORAL AB RS 1990-04-03 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A071795-001 SULINDAC 200MG TABLET / ORAL AB RS 1990-04-03 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A071795-001 SULINDAC 200MG TABLET / ORAL AB RS 1990-04-03 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A071795-001 SULINDAC 200MG TABLET / ORAL AB RS 1990-04-03 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A071795-001 SULINDAC 200MG TABLET / ORAL AB RS 1990-04-03 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A071795-001 SULINDAC 200MG TABLET / ORAL AB RS 1990-04-03 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A071795-001 SULINDAC 200MG TABLET / ORAL AB RS 1990-04-03 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A071795-001 SULINDAC 200MG TABLET / ORAL AB RS 1990-04-03 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A071795-001 SULINDAC 200MG TABLET / ORAL AB RS 1990-04-03 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A071795-001 SULINDAC 200MG TABLET / ORAL AB RS 1990-04-03 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A071795-001 SULINDAC 200MG TABLET / ORAL AB RS 1990-04-03 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A071795-001 SULINDAC 200MG TABLET / ORAL AB RS 1990-04-03 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A071795-001 SULINDAC 200MG TABLET / ORAL AB RS 1990-04-03 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A071795-001 SULINDAC 200MG TABLET / ORAL AB RS 1990-04-03 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A071795-001 SULINDAC 200MG TABLET / ORAL AB RS 1990-04-03 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A071795-001 SULINDAC 200MG TABLET / ORAL AB RS 1990-04-03 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 · 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 55289-930-10 Sulindac 10 in 1 BOTTLE, PLASTIC TABLET 10 14 55289-930-20 Sulindac 20 in 1 BOTTLE, PLASTIC TABLET 20 14 55289-930-30 Sulindac 30 in 1 BOTTLE, PLASTIC TABLET 30 14
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded SULINDAC ACTIVE INGREDIENT 184SNS8VUH SULINDAC TABLET [PD-RX PHARMACEUTICALS, INC.] 1 SULINDAC ACTIVE MOIETY 184SNS8VUH SULINDAC TABLET [PD-RX PHARMACEUTICALS, INC.] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U SULINDAC TABLET [PD-RX PHARMACEUTICALS, INC.] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 SULINDAC TABLET [PD-RX PHARMACEUTICALS, INC.] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ SULINDAC TABLET [PD-RX PHARMACEUTICALS, INC.] 1 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP SULINDAC TABLET [PD-RX PHARMACEUTICALS, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55289-930 SULINDAC TABLET [PD-RX PHARMACEUTICALS, INC.] 14 Current NDC, Legacy NDC, 3 package rows 20250322_68d4eeed-2501-494b-b979-502720de86c0.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 55289-930-10 55289093010 10 TABLET in 1 BOTTLE, PLASTIC (55289-930-10) 10 tablet 2010-07-12 0000-00-00 No No Current