Home NDC 50090-4976-0 Sulindac
Product NDC 50090-4976
Requested package NDC 50090-4976-0
11-digit product format 500904976
Labeler code 50090
Product ID 50090-4976_b69f939f-2e0b-480f-a811-284a327c865b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Sulindac
Dosage form TABLET
Route ORAL
Labeler A-S Medication Solutions
Application ANDA072711
Marketing category ANDA
Marketing start 2010-11-30
Marketing end 0000-00-00
Substance SULINDAC
Active strength 200 mg/1
Pharmacologic classes Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag No
Listing certified through 2022-12-31
Current FDA listing Historical FDA.report record 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 · 15 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 1332a3947898…d4bfe170f9cd…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A072711-001 SULINDAC SULINDAC 200MG TABLET / ORAL AB 1991-03-25 A072711-002 SULINDAC SULINDAC 150MG TABLET / ORAL AB 1991-03-25
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 · 45 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 A072711-001 SULINDAC 200MG TABLET / ORAL AB 1991-03-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A072711-002 SULINDAC 150MG TABLET / ORAL AB 1991-03-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A072711-001 SULINDAC 200MG TABLET / ORAL AB 1991-03-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A072711-002 SULINDAC 150MG TABLET / ORAL AB 1991-03-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A072711-001 SULINDAC 200MG TABLET / ORAL AB 1991-03-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A072711-002 SULINDAC 150MG TABLET / ORAL AB 1991-03-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A072711-001 SULINDAC 200MG TABLET / ORAL AB 1991-03-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A072711-001 SULINDAC 200MG TABLET / ORAL AB 1991-03-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A072711-001 SULINDAC 200MG TABLET / ORAL AB 1991-03-25 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A072711-001 SULINDAC 200MG TABLET / ORAL AB 1991-03-25 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A072711-001 SULINDAC 200MG TABLET / ORAL AB 1991-03-25 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A072711-001 SULINDAC 200MG TABLET / ORAL AB 1991-03-25 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A072711-001 SULINDAC 200MG TABLET / ORAL AB 1991-03-25 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A072711-001 SULINDAC 200MG TABLET / ORAL AB 1991-03-25 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A072711-001 SULINDAC 200MG TABLET / ORAL AB 1991-03-25 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A072711-001 SULINDAC 200MG TABLET / ORAL AB 1991-03-25 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A072711-001 SULINDAC 200MG TABLET / ORAL AB 1991-03-25 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A072711-001 SULINDAC 200MG TABLET / ORAL AB 1991-03-25 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A072711-001 SULINDAC 200MG TABLET / ORAL AB 1991-03-25 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A072711-001 SULINDAC 200MG TABLET / ORAL AB 1991-03-25 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A072711-001 SULINDAC 200MG TABLET / ORAL AB 1991-03-25 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A072711-001 SULINDAC 200MG TABLET / ORAL AB 1991-03-25 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A072711-001 SULINDAC 200MG TABLET / ORAL AB 1991-03-25 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A072711-001 SULINDAC 200MG TABLET / ORAL AB 1991-03-25 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A072711-001 SULINDAC 200MG TABLET / ORAL AB 1991-03-25 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A072711-001 SULINDAC 200MG TABLET / ORAL AB 1991-03-25 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A072711-001 SULINDAC 200MG TABLET / ORAL AB 1991-03-25 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A072711-001 SULINDAC 200MG TABLET / ORAL AB 1991-03-25 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A072711-001 SULINDAC 200MG TABLET / ORAL AB 1991-03-25 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A072711-001 SULINDAC 200MG TABLET / ORAL AB 1991-03-25 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A072711-001 SULINDAC 200MG TABLET / ORAL AB 1991-03-25 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A072711-001 SULINDAC 200MG TABLET / ORAL AB 1991-03-25 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A072711-001 SULINDAC 200MG TABLET / ORAL AB 1991-03-25 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A072711-001 SULINDAC 200MG TABLET / ORAL AB 1991-03-25 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A072711-001 SULINDAC 200MG TABLET / ORAL AB 1991-03-25 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A072711-001 SULINDAC 200MG TABLET / ORAL AB 1991-03-25 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A072711-001 SULINDAC 200MG TABLET / ORAL AB 1991-03-25 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A072711-001 SULINDAC 200MG TABLET / ORAL AB 1991-03-25 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A072711-001 SULINDAC 200MG TABLET / ORAL AB 1991-03-25 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A072711-001 SULINDAC 200MG TABLET / ORAL AB 1991-03-25 3a93d1ddd44b…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 45 observed states.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 50090-4976-0 Sulindac 14 in 1 BOTTLE TABLET 14 5 50090-4976-4 Sulindac 60 in 1 BOTTLE TABLET 60 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50090-4976 SULINDAC TABLET [A-S MEDICATION SOLUTIONS] 5 Legacy NDC, 2 package rows 20211028_ddbbaada-f55a-4032-a24c-a8c493933a45.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 · 4 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join SULINDAC SULINDAC A-S Medication Solutions 6041acc2-5e8a-4d3c-bf50-7e9447748e2b 2026-05-08 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 072711 application number: ANDA072711 SULINDAC SULINDAC PuraCap Laboratories LLC dba Blu Pharmaceuticals 0feabf47-8d0d-48c0-b263-43db4969f39e 2025-12-11 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 072711 application number: ANDA072711 SULINDAC SULINDAC Epic Pharma, LLC 96c73bd2-4577-487d-a642-bd8f91e94c3a 2024-12-20 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 072711 application number: ANDA072711 SULINDAC SULINDAC Proficient Rx LP d94e8865-d151-4fb1-bacd-f4e43819e3c2 2022-03-01 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 072711 application number: ANDA072711
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 50090-4976-0 50090497600 14 TABLET in 1 BOTTLE (50090-4976-0) 14 tablet 2020-03-27 0000-00-00 No No Current