Home NDC 50090-0529 SULINDAC
Product NDC 50090-0529
11-digit product format 500900529
Labeler code 50090
Product ID 50090-0529_4b79e8cf-aa02-4ef9-b1fd-62d80bd37dc8
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name SULINDAC
Dosage form TABLET
Route ORAL
Labeler A-S Medication Solutions
Application ANDA072711
Marketing category ANDA
Marketing start 2010-01-25
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 2027-12-31
Current FDA listing Yes 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 · 57 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 50090-0529-1 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 50090-0529-4 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 50090-0529-0 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 50090-0529-1 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 50090-0529-4 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 50090-0529-0 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 50090-0529-1 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 50090-0529-4 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 50090-0529-0 D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 50090-0529-1 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 50090-0529-4 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 50090-0529-0 D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 50090-0529-1 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 50090-0529-4 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 50090-0529-0 D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 50090-0529-1 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 50090-0529-4 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 50090-0529-0 D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product I Inactivated by FDA 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 50090-0529-1 I Inactivated by FDA 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 50090-0529-4 I Inactivated by FDA 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 50090-0529-0 D Discontinued by firm 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product I Inactivated by FDA ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 50090-0529-1 I Inactivated by FDA ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 50090-0529-4 I Inactivated by FDA ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 50090-0529-0 D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product I Inactivated by FDA 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 50090-0529-1 I Inactivated by FDA 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 50090-0529-4 I Inactivated by FDA 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 50090-0529-0 D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 50090-0529-1 I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 50090-0529-4 I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 50090-0529-0 D Discontinued by firm ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 50090-0529-1 I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 50090-0529-4 I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 50090-0529-0 D Discontinued by firm 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 50090-0529-1 I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 50090-0529-4 I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 50090-0529-0 D Discontinued by firm 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 50090-0529-1 I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 50090-0529-4 I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product I Inactivated by FDA 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 50090-0529-1 I Inactivated by FDA 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 50090-0529-4 I Inactivated by FDA 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 50090-0529-1 I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 50090-0529-4 I Inactivated by FDA 1332a3947898…d4bfe170f9cd…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 · 47 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 A072711-001 SULINDAC 200MG TABLET / ORAL AB 1991-03-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A072711-002 SULINDAC 150MG TABLET / ORAL AB 1991-03-25 caaa826d4ba7…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…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 47 observed states.
Additional Listing Data#
Finished product Yes
Brand name base SULINDAC
Listing expiration 2027-12-31 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# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 50090-0529-0 SULINDAC 14 in 1 BOTTLE TABLET 14 16 50090-0529-1 SULINDAC 30 in 1 BOTTLE TABLET 30 16 50090-0529-4 SULINDAC 60 in 1 BOTTLE TABLET 60 16
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50090-0529 SULINDAC TABLET [A-S MEDICATION SOLUTIONS] 14 Current NDC, Legacy NDC, 3 package rows 20190125_6041acc2-5e8a-4d3c-bf50-7e9447748e2b.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 ndc (product): 50090-0529 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 50090-0529-0 50090052900 14 in 1 BOTTLE Historical 50090-0529-1 50090052901 30 TABLET in 1 BOTTLE (50090-0529-1) 30 tablet 2014-11-28 0000-00-00 No No Current 50090-0529-4 50090052904 60 TABLET in 1 BOTTLE (50090-0529-4) 60 tablet 2016-06-29 0000-00-00 No No Current