Home NDC 0591-5661 Sulindac
Product NDC 0591-5661
11-digit product format 005915661
Labeler code 0591
Product ID 0591-5661_988f11c7-805d-4926-84b3-4c9c0cb0038d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Sulindac
Dosage form TABLET
Route ORAL
Labeler Actavis Pharma, Inc.
Application ANDA071891
Marketing category ANDA
Marketing start 1990-04-03
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 NDC auxiliary status# These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
Current NDC status page 1 of 1 · 3 matching rows.
Dataset, Scope, Product NDC table Dataset Scope Product NDC Package NDC Code Status Reporting period Source date unfinished product product 0591-5661 UNFINISHED Active or certified unfinished drug listing 2026-08-17 unfinished package package 0591-5661 0591-5661-00 UNFINISHED Active or certified unfinished drug listing 2026-08-17 unfinished package package 0591-5661 0591-5661-77 UNFINISHED Active or certified unfinished drug listing 2026-08-17
Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 54 matching rows.
View current auxiliary records. · View the auxiliary file history.
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 A071891-001 SULINDAC SULINDAC 150MG TABLET / ORAL AB 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 A071891-001 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 A071891-001 SULINDAC 150MG TABLET / ORAL AB 1990-04-03 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A071891-001 SULINDAC 150MG TABLET / ORAL AB 1990-04-03 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A071891-001 SULINDAC 150MG TABLET / ORAL AB 1990-04-03 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A071891-001 SULINDAC 150MG TABLET / ORAL AB 1990-04-03 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A071891-001 SULINDAC 150MG TABLET / ORAL AB 1990-04-03 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A071891-001 SULINDAC 150MG TABLET / ORAL AB 1990-04-03 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A071891-001 SULINDAC 150MG TABLET / ORAL AB 1990-04-03 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A071891-001 SULINDAC 150MG TABLET / ORAL AB 1990-04-03 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A071891-001 SULINDAC 150MG TABLET / ORAL AB 1990-04-03 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A071891-001 SULINDAC 150MG TABLET / ORAL AB 1990-04-03 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A071891-001 SULINDAC 150MG TABLET / ORAL AB 1990-04-03 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A071891-001 SULINDAC 150MG TABLET / ORAL AB 1990-04-03 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A071891-001 SULINDAC 150MG TABLET / ORAL AB 1990-04-03 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A071891-001 SULINDAC 150MG TABLET / ORAL AB 1990-04-03 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A071891-001 SULINDAC 150MG TABLET / ORAL AB 1990-04-03 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A071891-001 SULINDAC 150MG TABLET / ORAL AB 1990-04-03 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A071891-001 SULINDAC 150MG TABLET / ORAL AB 1990-04-03 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A071891-001 SULINDAC 150MG TABLET / ORAL AB 1990-04-03 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A071891-001 SULINDAC 150MG TABLET / ORAL AB 1990-04-03 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A071891-001 SULINDAC 150MG TABLET / ORAL AB 1990-04-03 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A071891-001 SULINDAC 150MG TABLET / ORAL AB 1990-04-03 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A071891-001 SULINDAC 150MG TABLET / ORAL AB 1990-04-03 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A071891-001 SULINDAC 150MG TABLET / ORAL AB 1990-04-03 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A071891-001 SULINDAC 150MG TABLET / ORAL AB 1990-04-03 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A071891-001 SULINDAC 150MG TABLET / ORAL AB 1990-04-03 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A071891-001 SULINDAC 150MG TABLET / ORAL AB 1990-04-03 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A071891-001 SULINDAC 150MG TABLET / ORAL AB 1990-04-03 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A071891-001 SULINDAC 150MG TABLET / ORAL AB 1990-04-03 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A071891-001 SULINDAC 150MG TABLET / ORAL AB 1990-04-03 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A071891-001 SULINDAC 150MG TABLET / ORAL AB 1990-04-03 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A071891-001 SULINDAC 150MG TABLET / ORAL AB 1990-04-03 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A071891-001 SULINDAC 150MG TABLET / ORAL AB 1990-04-03 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A071891-001 SULINDAC 150MG TABLET / ORAL AB 1990-04-03 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A071891-001 SULINDAC 150MG TABLET / ORAL AB 1990-04-03 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A071891-001 SULINDAC 150MG TABLET / ORAL AB 1990-04-03 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A071891-001 SULINDAC 150MG TABLET / ORAL AB 1990-04-03 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A071891-001 SULINDAC 150MG TABLET / ORAL AB 1990-04-03 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A071891-001 SULINDAC 150MG TABLET / ORAL AB 1990-04-03 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A071891-001 SULINDAC 150MG TABLET / ORAL AB 1990-04-03 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A071891-001 SULINDAC 150MG TABLET / ORAL AB 1990-04-03 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 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 0591-5661-01 Sulindac 100 in 1 BOTTLE, PLASTIC TABLET 100 13 0591-5661-05 Sulindac 500 in 1 BOTTLE, PLASTIC TABLET 500 13
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded SULINDAC ACTIVE INGREDIENT 184SNS8VUH SULINDAC TABLET [PHYSICIANS TOTAL CARE, INC.] 2 SULINDAC ACTIVE MOIETY 184SNS8VUH SULINDAC TABLET [PHYSICIANS TOTAL CARE, INC.] 2 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U SULINDAC TABLET [PHYSICIANS TOTAL CARE, INC.] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 SULINDAC TABLET [PHYSICIANS TOTAL CARE, INC.] 2 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ SULINDAC TABLET [PHYSICIANS TOTAL CARE, INC.] 2 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP SULINDAC TABLET [PHYSICIANS TOTAL CARE, INC.] 2 SULINDAC ACTIVE INGREDIENT 184SNS8VUH SULINDAC TABLET [WATSON LABORATORIES, INC.] 1 SULINDAC ACTIVE MOIETY 184SNS8VUH SULINDAC TABLET [WATSON LABORATORIES, INC.] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U SULINDAC TABLET [WATSON LABORATORIES, INC.] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 SULINDAC TABLET [WATSON LABORATORIES, INC.] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ SULINDAC TABLET [WATSON LABORATORIES, INC.] 1 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP SULINDAC TABLET [WATSON LABORATORIES, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0591-5661 SULINDAC TABLET [ACTAVIS PHARMA, INC.] 13 Current NDC, Legacy NDC, 2 package rows 20241210_d8b9d517-5dd4-4c6b-8aa0-736bce87e7b4.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 · 1 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 0591-5661-00 00591566100 39000 TABLET in 1 BAG (0591-5661-00) 39000 tablet 03-APR-90 Current 0591-5661-01 00591566101 100 TABLET in 1 BOTTLE, PLASTIC (0591-5661-01) 100 tablet 1990-04-03 0000-00-00 No No Current 0591-5661-05 00591566105 500 TABLET in 1 BOTTLE, PLASTIC (0591-5661-05) 500 tablet 1990-04-03 0000-00-00 No No Current 0591-5661-77 00591566177 47064 TABLET in 1 CONTAINER (0591-5661-77) 47064 tablet 11-JUN-24 Current