Home NDC 70771-1083 Diflunisal
Product NDC 70771-1083
11-digit product format 707711083
Labeler code 70771
Product ID 70771-1083_d5395b92-79af-436c-82ac-a6b70cd3b139
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Diflunisal
Dosage form TABLET
Route ORAL
Labeler Zydus Lifesciences Limited
Application ANDA203547
Marketing category ANDA
Marketing start 2017-09-14
Substance DIFLUNISAL
Active strength 500 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 · source snapshot 1 .
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 A203547-001 DIFLUNISAL DIFLUNISAL 500MG TABLET / ORAL AB 2017-06-16
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A203547-001 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 · 41 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 A203547-001 DIFLUNISAL 500MG TABLET / ORAL AB 2017-06-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203547-001 DIFLUNISAL 500MG TABLET / ORAL AB 2017-06-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A203547-001 DIFLUNISAL 500MG TABLET / ORAL AB 2017-06-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203547-001 DIFLUNISAL 500MG TABLET / ORAL AB 2017-06-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203547-001 DIFLUNISAL 500MG TABLET / ORAL AB 2017-06-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203547-001 DIFLUNISAL 500MG TABLET / ORAL AB 2017-06-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203547-001 DIFLUNISAL 500MG TABLET / ORAL AB 2017-06-16 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203547-001 DIFLUNISAL 500MG TABLET / ORAL AB 2017-06-16 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203547-001 DIFLUNISAL 500MG TABLET / ORAL AB 2017-06-16 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A203547-001 DIFLUNISAL 500MG TABLET / ORAL AB 2017-06-16 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203547-001 DIFLUNISAL 500MG TABLET / ORAL AB 2017-06-16 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A203547-001 DIFLUNISAL 500MG TABLET / ORAL AB 2017-06-16 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A203547-001 DIFLUNISAL 500MG TABLET / ORAL AB 2017-06-16 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A203547-001 DIFLUNISAL 500MG TABLET / ORAL AB 2017-06-16 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A203547-001 DIFLUNISAL 500MG TABLET / ORAL AB 2017-06-16 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A203547-001 DIFLUNISAL 500MG TABLET / ORAL AB 2017-06-16 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A203547-001 DIFLUNISAL 500MG TABLET / ORAL AB 2017-06-16 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A203547-001 DIFLUNISAL 500MG TABLET / ORAL AB 2017-06-16 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A203547-001 DIFLUNISAL 500MG TABLET / ORAL AB 2017-06-16 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A203547-001 DIFLUNISAL 500MG TABLET / ORAL AB 2017-06-16 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A203547-001 DIFLUNISAL 500MG TABLET / ORAL AB 2017-06-16 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A203547-001 DIFLUNISAL 500MG TABLET / ORAL AB 2017-06-16 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A203547-001 DIFLUNISAL 500MG TABLET / ORAL AB 2017-06-16 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A203547-001 DIFLUNISAL 500MG TABLET / ORAL AB 2017-06-16 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A203547-001 DIFLUNISAL 500MG TABLET / ORAL AB 2017-06-16 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A203547-001 DIFLUNISAL 500MG TABLET / ORAL AB 2017-06-16 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A203547-001 DIFLUNISAL 500MG TABLET / ORAL AB 2017-06-16 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A203547-001 DIFLUNISAL 500MG TABLET / ORAL AB 2017-06-16 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A203547-001 DIFLUNISAL 500MG TABLET / ORAL AB 2017-06-16 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A203547-001 DIFLUNISAL 500MG TABLET / ORAL AB 2017-06-16 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A203547-001 DIFLUNISAL 500MG TABLET / ORAL AB 2017-06-16 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A203547-001 DIFLUNISAL 500MG TABLET / ORAL AB 2017-06-16 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A203547-001 DIFLUNISAL 500MG TABLET / ORAL AB 2017-06-16 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A203547-001 DIFLUNISAL 500MG TABLET / ORAL AB 2017-06-16 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A203547-001 DIFLUNISAL 500MG TABLET / ORAL AB 2017-06-16 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A203547-001 DIFLUNISAL 500MG TABLET / ORAL AB 2017-06-16 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A203547-001 DIFLUNISAL 500MG TABLET / ORAL AB 2017-06-16 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A203547-001 DIFLUNISAL 500MG TABLET / ORAL AB 2017-06-16 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A203547-001 DIFLUNISAL 500MG TABLET / ORAL AB 2017-06-16 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A203547-001 DIFLUNISAL 500MG TABLET / ORAL AB 2017-06-16 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Diflunisal
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DIFLUNISAL 500 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 7C546U4DEN Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 197603 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70771-1083 DIFLUNISAL TABLET [ZYDUS LIFESCIENCES LIMITED] 5 Current NDC, Legacy NDC, 8 package rows 20241123_d7a722be-4612-4b2e-827d-56fb5eef0aae.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 70771-1083-0 70771108300 1000 TABLET in 1 BOTTLE (70771-1083-0) 1000 tablet 2017-09-14 0000-00-00 No No Current 70771-1083-1 70771108301 100 TABLET in 1 BOTTLE (70771-1083-1) 100 tablet 2017-09-14 0000-00-00 No No Current 70771-1083-3 70771108303 30 TABLET in 1 BOTTLE (70771-1083-3) 30 tablet 2017-09-14 0000-00-00 No No Current 70771-1083-5 70771108305 500 TABLET in 1 BOTTLE (70771-1083-5) 500 tablet 2017-09-14 0000-00-00 No No Current 70771-1083-6 70771108306 60 TABLET in 1 BOTTLE (70771-1083-6) 60 tablet 2017-09-14 0000-00-00 No No Current 70771-1083-8 70771108308 10 BLISTER PACK in 1 CARTON (70771-1083-8) / 10 TABLET in 1 BLISTER PACK 10 blister pack 2017-09-14 0000-00-00 No No Current 70771-1083-9 70771108309 90 TABLET in 1 BOTTLE (70771-1083-9) 90 tablet 2017-09-14 0000-00-00 No No Current