Home NDC 0093-9222 Diflunisal
Product NDC 0093-9222
11-digit product format 000939222
Labeler code 0093
Product ID 0093-9222_673f00c6-1759-47a6-a098-fd61baf13d1e
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 2021-06-30
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 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.
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# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0093-9222-01 Diflunisal 100 in 1 BOTTLE TABLET, FILM COATED 100 21 0093-9222-05 Diflunisal 500 in 1 BOTTLE TABLET, FILM COATED 500 21 0093-9222-06 Diflunisal 60 in 1 BOTTLE TABLET, FILM COATED 60 21
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded DIFLUNISAL ACTIVE INGREDIENT 7C546U4DEN DIFLUNISAL TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 5 DIFLUNISAL ACTIVE MOIETY 7C546U4DEN DIFLUNISAL TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 5 ALUMINUM OXIDE INACTIVE INGREDIENT LMI26O6933 DIFLUNISAL TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 5 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U DIFLUNISAL TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 5 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 DIFLUNISAL TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 5 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK DIFLUNISAL TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 5 HYPROMELLOSE 2910 (15 MPA.S) INACTIVE INGREDIENT 36SFW2JZ0W DIFLUNISAL TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 5 HYPROMELLOSE 2910 (6 MPA.S) INACTIVE INGREDIENT 0WZ8WG20P6 DIFLUNISAL TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 5 INDIGOTINDISULFONATE SODIUM INACTIVE INGREDIENT D3741U8K7L DIFLUNISAL TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 5 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 DIFLUNISAL TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 5 SODIUM STEARYL FUMARATE INACTIVE INGREDIENT 7CV7WJK4UI DIFLUNISAL TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 5 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ DIFLUNISAL TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 5 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP DIFLUNISAL TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0093-9222 DIFLUNISAL TABLET, FILM COATED [TEVA PHARMACEUTICALS USA, INC.] 21 Current NDC, Legacy NDC, 3 package rows 20241219_7a78bb38-14d8-4a90-b883-482d4cebf716.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 · 1 matching rows.
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 0093-9222-01 00093922201 100 TABLET, FILM COATED in 1 BOTTLE (0093-9222-01) 2021-06-30 0000-00-00 No No Current 0093-9222-05 00093922205 500 TABLET, FILM COATED in 1 BOTTLE (0093-9222-05) 2022-08-25 0000-00-00 No No Current 0093-9222-06 00093922206 60 TABLET, FILM COATED in 1 BOTTLE (0093-9222-06) 2021-06-30 0000-00-00 No No Current