Home NDC 60760-756-14 Diflunisal
Product NDC 60760-756
Requested package NDC 60760-756-14
11-digit product format 607600756
Labeler code 60760
Product ID 60760-756_7a8060ac-5586-6e7e-e053-2a91aa0a0017
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Diflunisal
Dosage form TABLET, FILM COATED
Route ORAL
Labeler St. Mary's Medical Park Pharmacy
Application ANDA073673
Marketing category ANDA
Marketing start 2018-03-28
Marketing end 0000-00-00
Substance DIFLUNISAL
Active strength 500 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 2020-12-31
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 · 12 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…
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 A073673-001 DIFLUNISAL DIFLUNISAL 500MG TABLET / ORAL AB RS 1992-07-31
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A073673-001 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 A073673-001 DIFLUNISAL 500MG TABLET / ORAL AB RS 1992-07-31 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A073673-001 DIFLUNISAL 500MG TABLET / ORAL AB RS 1992-07-31 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A073673-001 DIFLUNISAL 500MG TABLET / ORAL AB RS 1992-07-31 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A073673-001 DIFLUNISAL 500MG TABLET / ORAL AB RS 1992-07-31 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A073673-001 DIFLUNISAL 500MG TABLET / ORAL AB RS 1992-07-31 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A073673-001 DIFLUNISAL 500MG TABLET / ORAL AB RS 1992-07-31 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A073673-001 DIFLUNISAL 500MG TABLET / ORAL AB RS 1992-07-31 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A073673-001 DIFLUNISAL 500MG TABLET / ORAL AB RS 1992-07-31 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A073673-001 DIFLUNISAL 500MG TABLET / ORAL AB RS 1992-07-31 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A073673-001 DIFLUNISAL 500MG TABLET / ORAL AB RS 1992-07-31 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A073673-001 DIFLUNISAL 500MG TABLET / ORAL AB RS 1992-07-31 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A073673-001 DIFLUNISAL 500MG TABLET / ORAL AB RS 1992-07-31 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A073673-001 DIFLUNISAL 500MG TABLET / ORAL AB RS 1992-07-31 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A073673-001 DIFLUNISAL 500MG TABLET / ORAL AB RS 1992-07-31 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A073673-001 DIFLUNISAL 500MG TABLET / ORAL AB RS 1992-07-31 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A073673-001 DIFLUNISAL 500MG TABLET / ORAL AB RS 1992-07-31 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A073673-001 DIFLUNISAL 500MG TABLET / ORAL AB RS 1992-07-31 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A073673-001 DIFLUNISAL 500MG TABLET / ORAL AB RS 1992-07-31 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A073673-001 DIFLUNISAL 500MG TABLET / ORAL AB RS 1992-07-31 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A073673-001 DIFLUNISAL 500MG TABLET / ORAL AB RS 1992-07-31 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A073673-001 DIFLUNISAL 500MG TABLET / ORAL AB RS 1992-07-31 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A073673-001 DIFLUNISAL 500MG TABLET / ORAL AB RS 1992-07-31 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A073673-001 DIFLUNISAL 500MG TABLET / ORAL AB RS 1992-07-31 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A073673-001 DIFLUNISAL 500MG TABLET / ORAL AB RS 1992-07-31 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A073673-001 DIFLUNISAL 500MG TABLET / ORAL AB RS 1992-07-31 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A073673-001 DIFLUNISAL 500MG TABLET / ORAL AB RS 1992-07-31 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A073673-001 DIFLUNISAL 500MG TABLET / ORAL AB RS 1992-07-31 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A073673-001 DIFLUNISAL 500MG TABLET / ORAL AB RS 1992-07-31 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A073673-001 DIFLUNISAL 500MG TABLET / ORAL AB RS 1992-07-31 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A073673-001 DIFLUNISAL 500MG TABLET / ORAL AB RS 1992-07-31 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A073673-001 DIFLUNISAL 500MG TABLET / ORAL AB RS 1992-07-31 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A073673-001 DIFLUNISAL 500MG TABLET / ORAL AB RS 1992-07-31 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A073673-001 DIFLUNISAL 500MG TABLET / ORAL AB RS 1992-07-31 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A073673-001 DIFLUNISAL 500MG TABLET / ORAL AB RS 1992-07-31 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A073673-001 DIFLUNISAL 500MG TABLET / ORAL AB RS 1992-07-31 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A073673-001 DIFLUNISAL 500MG TABLET / ORAL AB RS 1992-07-31 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A073673-001 DIFLUNISAL 500MG TABLET / ORAL AB RS 1992-07-31 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A073673-001 DIFLUNISAL 500MG TABLET / ORAL AB RS 1992-07-31 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A073673-001 DIFLUNISAL 500MG TABLET / ORAL AB RS 1992-07-31 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A073673-001 DIFLUNISAL 500MG TABLET / ORAL AB RS 1992-07-31 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
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 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Diflunisal DIFLUNISAL Teva Pharmaceuticals USA, Inc. 7a78bb38-14d8-4a90-b883-482d4cebf716 2024-07-16 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 073673 application number: ANDA073673
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 60760-756-14 60760075614 14 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (60760-756-14) 2018-03-28 0000-00-00 No No Current