Home NDC 0093-0755 Diflunisal
Product NDC 0093-0755
11-digit product format 000930755
Labeler code 0093
Product ID 0093-0755_8b62b5af-d2a9-4d06-a78b-23f92523c19f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Diflunisal
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Teva Pharmaceuticals USA, Inc.
Application ANDA073673
Marketing category ANDA
Marketing start 1992-11-01
Marketing end 2022-08-31
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 0000-00-00
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 · 48 matching rows.
View current auxiliary records. · View the auxiliary file history.
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.
DailyMed Product Concepts# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded DIFLUNISAL ACTIVE INGREDIENT 7C546U4DEN DIFLUNISAL TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 4 DIFLUNISAL ACTIVE MOIETY 7C546U4DEN DIFLUNISAL TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 4 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U DIFLUNISAL TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 4 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 DIFLUNISAL TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 4 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK DIFLUNISAL TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 4 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO DIFLUNISAL TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 4 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 DIFLUNISAL TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 4 SODIUM STEARYL FUMARATE INACTIVE INGREDIENT 7CV7WJK4UI DIFLUNISAL TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 4 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ DIFLUNISAL TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 4 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP DIFLUNISAL TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 4 DIFLUNISAL ACTIVE INGREDIENT 7C546U4DEN DIFLUNISAL TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT] 2 DIFLUNISAL ACTIVE MOIETY 7C546U4DEN DIFLUNISAL TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT] 2 ALUMINUM OXIDE INACTIVE INGREDIENT LMI26O6933 DIFLUNISAL TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT] 2 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U DIFLUNISAL TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT] 2 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 DIFLUNISAL TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT] 2 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK DIFLUNISAL TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT] 2 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO DIFLUNISAL TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT] 2 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 DIFLUNISAL TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT] 2 SODIUM STEARYL FUMARATE INACTIVE INGREDIENT 7CV7WJK4UI DIFLUNISAL TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT] 2 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ DIFLUNISAL TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT] 2 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP DIFLUNISAL TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT] 2
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
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 0093-0755-01 00093075501 100 TABLET, FILM COATED in 1 BOTTLE (0093-0755-01) 1992-11-01 0000-00-00 No No Current 0093-0755-05 00093075505 500 TABLET, FILM COATED in 1 BOTTLE (0093-0755-05) 1992-11-01 0000-00-00 No No Current 0093-0755-06 00093075506 60 TABLET, FILM COATED in 1 BOTTLE (0093-0755-06) 1992-11-01 2022-08-31 No No Current