Home NDC 42806-018 SULINDAC
Product NDC 42806-018
11-digit product format 428060018
Labeler code 42806
Product ID 42806-018_fb793a0a-affa-4f9a-a5b4-aa1c84aa475e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name SULINDAC
Dosage form TABLET
Route ORAL
Labeler Epic Pharma, LLC
Application ANDA072710
Marketing category ANDA
Marketing start 2010-01-25
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 42806-018-01 SULINDAC 100 in 1 BOTTLE TABLET 100 19 42806-018-05 SULINDAC 500 in 1 BOTTLE TABLET 500 19 42806-018-10 SULINDAC 1000 in 1 BOTTLE TABLET 1000 19
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded SULINDAC ACTIVE INGREDIENT 184SNS8VUH SULINDAC TABLET [EPIC PHARMA, LLC] 9 SULINDAC ACTIVE MOIETY 184SNS8VUH SULINDAC TABLET [EPIC PHARMA, LLC] 9 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U SULINDAC TABLET [EPIC PHARMA, LLC] 9 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 SULINDAC TABLET [EPIC PHARMA, LLC] 9 POVIDONE K29/32 INACTIVE INGREDIENT 390RMW2PEQ SULINDAC TABLET [EPIC PHARMA, LLC] 9 POVIDONE K30 INACTIVE INGREDIENT U725QWY32X SULINDAC TABLET [EPIC PHARMA, LLC] 9 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 SULINDAC TABLET [EPIC PHARMA, LLC] 9
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 42806-018 SULINDAC TABLET [EPIC PHARMA, LLC] 19 Current NDC, Legacy NDC, 3 package rows 20241222_96c73bd2-4577-487d-a642-bd8f91e94c3a.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 42806-018-01 42806001801 100 TABLET in 1 BOTTLE (42806-018-01) 100 tablet 2010-01-25 0000-00-00 No No Current 42806-018-05 42806001805 500 TABLET in 1 BOTTLE (42806-018-05) 500 tablet 2010-01-25 0000-00-00 No No Current 42806-018-10 42806001810 1000 TABLET in 1 BOTTLE (42806-018-10) 1000 tablet 2010-01-25 0000-00-00 No No Current