Home NDC 0093-1078 Cefprozil
Product NDC 0093-1078
11-digit product format 000931078
Labeler code 0093
Product ID 0093-1078_c226712f-00c2-407f-8b40-5ed1be54dfb8
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Cefprozil
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Teva Pharmaceuticals USA, Inc.
Application ANDA065208
Marketing category ANDA
Marketing start 2005-12-23
Substance CEFPROZIL
Active strength 500 mg/1
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 42 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A065208-001 CEFPROZIL CEFPROZIL 250MG TABLET / ORAL AB 2005-12-06 A065208-002 CEFPROZIL CEFPROZIL 500MG TABLET / ORAL AB 2005-12-06
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 3 · 84 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 2026-08-18 06:07:40 2026-07 A065208-001 CEFPROZIL 250MG TABLET / ORAL AB 2005-12-06 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A065208-002 CEFPROZIL 500MG TABLET / ORAL AB 2005-12-06 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A065208-001 CEFPROZIL 250MG TABLET / ORAL AB 2005-12-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A065208-002 CEFPROZIL 500MG TABLET / ORAL AB 2005-12-06 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065208-001 CEFPROZIL 250MG TABLET / ORAL AB 2005-12-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065208-002 CEFPROZIL 500MG TABLET / ORAL AB 2005-12-06 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A065208-001 CEFPROZIL 250MG TABLET / ORAL AB 2005-12-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A065208-002 CEFPROZIL 500MG TABLET / ORAL AB 2005-12-06 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065208-001 CEFPROZIL 250MG TABLET / ORAL AB 2005-12-06 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065208-002 CEFPROZIL 500MG TABLET / ORAL AB 2005-12-06 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065208-001 CEFPROZIL 250MG TABLET / ORAL AB 2005-12-06 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065208-002 CEFPROZIL 500MG TABLET / ORAL AB 2005-12-06 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065208-001 CEFPROZIL 250MG TABLET / ORAL AB 2005-12-06 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065208-002 CEFPROZIL 500MG TABLET / ORAL AB 2005-12-06 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065208-001 CEFPROZIL 250MG TABLET / ORAL AB 2005-12-06 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065208-002 CEFPROZIL 500MG TABLET / ORAL AB 2005-12-06 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065208-001 CEFPROZIL 250MG TABLET / ORAL AB 2005-12-06 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065208-002 CEFPROZIL 500MG TABLET / ORAL AB 2005-12-06 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065208-001 CEFPROZIL 250MG TABLET / ORAL AB 2005-12-06 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065208-002 CEFPROZIL 500MG TABLET / ORAL AB 2005-12-06 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A065208-001 CEFPROZIL 250MG TABLET / ORAL AB 2005-12-06 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A065208-002 CEFPROZIL 500MG TABLET / ORAL AB 2005-12-06 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065208-001 CEFPROZIL 250MG TABLET / ORAL AB 2005-12-06 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065208-002 CEFPROZIL 500MG TABLET / ORAL AB 2005-12-06 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065208-001 CEFPROZIL 250MG TABLET / ORAL AB 2005-12-06 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065208-002 CEFPROZIL 500MG TABLET / ORAL AB 2005-12-06 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A065208-001 CEFPROZIL 250MG TABLET / ORAL AB 2005-12-06 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A065208-002 CEFPROZIL 500MG TABLET / ORAL AB 2005-12-06 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A065208-001 CEFPROZIL 250MG TABLET / ORAL AB 2005-12-06 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A065208-002 CEFPROZIL 500MG TABLET / ORAL AB 2005-12-06 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A065208-001 CEFPROZIL 250MG TABLET / ORAL AB 2005-12-06 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A065208-002 CEFPROZIL 500MG TABLET / ORAL AB 2005-12-06 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A065208-001 CEFPROZIL 250MG TABLET / ORAL AB 2005-12-06 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A065208-002 CEFPROZIL 500MG TABLET / ORAL AB 2005-12-06 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A065208-001 CEFPROZIL 250MG TABLET / ORAL AB 2005-12-06 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A065208-002 CEFPROZIL 500MG TABLET / ORAL AB 2005-12-06 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A065208-001 CEFPROZIL 250MG TABLET / ORAL AB 2005-12-06 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A065208-002 CEFPROZIL 500MG TABLET / ORAL AB 2005-12-06 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A065208-001 CEFPROZIL 250MG TABLET / ORAL AB 2005-12-06 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A065208-002 CEFPROZIL 500MG TABLET / ORAL AB 2005-12-06 bb7c543d1eb4…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 84 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Cefprozil
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CEFPROZIL 500 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 4W0459ZA4V Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 197452 Internal RxNorm lookup 197453 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 0093-1078-53 Cefprozil 50 in 1 BOTTLE TABLET, FILM COATED 50 9
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded CEFPROZIL ACTIVE INGREDIENT 4W0459ZA4V CEFPROZIL TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 5 CEFPROZIL ANHYDROUS ACTIVE MOIETY 1M698F4H4E CEFPROZIL TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 5 ALUMINUM OXIDE INACTIVE INGREDIENT LMI26O6933 CEFPROZIL TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 5 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U CEFPROZIL TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 5 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G CEFPROZIL TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 5 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA CEFPROZIL TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 5 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 CEFPROZIL TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 5 HYPROMELLOSE 2910 (3 MPA.S) INACTIVE INGREDIENT 0VUT3PMY82 CEFPROZIL TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 5 HYPROMELLOSE 2910 (6 MPA.S) INACTIVE INGREDIENT 0WZ8WG20P6 CEFPROZIL TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 5 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO CEFPROZIL TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 5 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 CEFPROZIL TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 5 POLYETHYLENE GLYCOL 400 INACTIVE INGREDIENT B697894SGQ CEFPROZIL TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 5 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H CEFPROZIL TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 5 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 CEFPROZIL TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 5 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP CEFPROZIL 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 0093-1078 CEFPROZIL TABLET, FILM COATED [TEVA PHARMACEUTICALS USA, INC.] 9 Current NDC, Legacy NDC, 1 package rows 20220315_3391de8b-7bc9-4624-a5c4-836135b39d99.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 0093-1078-53 00093107853 50 TABLET, FILM COATED in 1 BOTTLE (0093-1078-53) 2005-12-23 0000-00-00 No No Current