Home NDC 24658-770 SULINDAC
Product NDC 24658-770
11-digit product format 246580770
Labeler code 24658
Product ID 24658-770_cb28dfa2-28af-47a2-ab7f-1c65720d9496
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name SULINDAC
Dosage form TABLET
Route ORAL
Labeler PuraCap Laboratories LLC dba Blu Pharmaceuticals
Application ANDA072710
Marketing category ANDA
Marketing start 2016-11-14
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 Source provenance: Browse the complete Orange Book source catalog .
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.
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 2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A072710-001 SULINDAC 150MG TABLET / ORAL AB 1991-03-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A072710-001 SULINDAC 150MG TABLET / ORAL AB 1991-03-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A072710-001 SULINDAC 150MG TABLET / ORAL AB 1991-03-25 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A072710-001 SULINDAC 150MG TABLET / ORAL AB 1991-03-25 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A072710-001 SULINDAC 150MG TABLET / ORAL AB 1991-03-25 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A072710-001 SULINDAC 150MG TABLET / ORAL AB 1991-03-25 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A072710-001 SULINDAC 150MG TABLET / ORAL AB 1991-03-25 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A072710-001 SULINDAC 150MG TABLET / ORAL AB 1991-03-25 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A072710-001 SULINDAC 150MG TABLET / ORAL AB 1991-03-25 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A072710-001 SULINDAC 150MG TABLET / ORAL AB 1991-03-25 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A072710-001 SULINDAC 150MG TABLET / ORAL AB 1991-03-25 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A072710-001 SULINDAC 150MG TABLET / ORAL AB 1991-03-25 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A072710-001 SULINDAC 150MG TABLET / ORAL AB 1991-03-25 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A072710-001 SULINDAC 150MG TABLET / ORAL AB 1991-03-25 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A072710-001 SULINDAC 150MG TABLET / ORAL AB 1991-03-25 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A072710-001 SULINDAC 150MG TABLET / ORAL AB 1991-03-25 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A072710-001 SULINDAC 150MG TABLET / ORAL AB 1991-03-25 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A072710-001 SULINDAC 150MG TABLET / ORAL AB 1991-03-25 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A072710-001 SULINDAC 150MG TABLET / ORAL AB 1991-03-25 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A072710-001 SULINDAC 150MG TABLET / ORAL AB 1991-03-25 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A072710-001 SULINDAC 150MG TABLET / ORAL AB 1991-03-25 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A072710-001 SULINDAC 150MG TABLET / ORAL AB 1991-03-25 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A072710-001 SULINDAC 150MG TABLET / ORAL AB 1991-03-25 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A072710-001 SULINDAC 150MG TABLET / ORAL AB 1991-03-25 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A072710-001 SULINDAC 150MG TABLET / ORAL AB 1991-03-25 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A072710-001 SULINDAC 150MG TABLET / ORAL AB 1991-03-25 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A072710-001 SULINDAC 150MG TABLET / ORAL AB 1991-03-25 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A072710-001 SULINDAC 150MG TABLET / ORAL AB 1991-03-25 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A072710-001 SULINDAC 150MG TABLET / ORAL AB 1991-03-25 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A072710-001 SULINDAC 150MG TABLET / ORAL AB 1991-03-25 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A072710-001 SULINDAC 150MG TABLET / ORAL AB 1991-03-25 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A072710-001 SULINDAC 150MG TABLET / ORAL AB 1991-03-25 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A072710-001 SULINDAC 150MG TABLET / ORAL AB 1991-03-25 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A072710-001 SULINDAC 150MG TABLET / ORAL AB 1991-03-25 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A072710-001 SULINDAC 150MG TABLET / ORAL AB 1991-03-25 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A072710-001 SULINDAC 150MG TABLET / ORAL AB 1991-03-25 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A072710-001 SULINDAC 150MG TABLET / ORAL AB 1991-03-25 cb3db0bc1861…
Observed Orange Book normalized TE history# 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 24658-770-01 SULINDAC 100 in 1 BOTTLE TABLET 100 9 24658-770-05 SULINDAC 500 in 1 BOTTLE TABLET 500 9
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 24658-770 SULINDAC TABLET [PURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS] 8 Current NDC, Legacy NDC, 2 package rows 20231221_0feabf47-8d0d-48c0-b263-43db4969f39e.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 24658-770-01 24658077001 100 TABLET in 1 BOTTLE (24658-770-01) 100 tablet 2016-11-14 0000-00-00 No No Current 24658-770-05 24658077005 500 TABLET in 1 BOTTLE (24658-770-05) 500 tablet 2016-11-14 0000-00-00 No No Current