Home NDC 0781-5044 Cefprozil
Product NDC 0781-5044
11-digit product format 007815044
Labeler code 0781
Product ID 0781-5044_4272315e-8350-44d3-ab67-49488f766f61
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Cefprozil
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Sandoz Inc
Application ANDA065235
Marketing category ANDA
Marketing start 2005-11-14
Marketing end 0000-00-00
Substance CEFPROZIL
Active strength 500 mg/1
NDC exclude flag No
Listing certified through 2019-12-31
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 · 36 matching rows.
View current auxiliary records. · View the auxiliary file history.
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 A065235-001 CEFPROZIL CEFPROZIL 250MG TABLET / ORAL AB 2005-11-14 A065235-002 CEFPROZIL CEFPROZIL 500MG TABLET / ORAL AB 2005-11-14
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 A065235-001 CEFPROZIL 250MG TABLET / ORAL AB 2005-11-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A065235-002 CEFPROZIL 500MG TABLET / ORAL AB 2005-11-14 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A065235-001 CEFPROZIL 250MG TABLET / ORAL AB 2005-11-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A065235-002 CEFPROZIL 500MG TABLET / ORAL AB 2005-11-14 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065235-001 CEFPROZIL 250MG TABLET / ORAL AB 2005-11-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065235-002 CEFPROZIL 500MG TABLET / ORAL AB 2005-11-14 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A065235-001 CEFPROZIL 250MG TABLET / ORAL AB 2005-11-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A065235-002 CEFPROZIL 500MG TABLET / ORAL AB 2005-11-14 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065235-001 CEFPROZIL 250MG TABLET / ORAL AB 2005-11-14 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065235-002 CEFPROZIL 500MG TABLET / ORAL AB 2005-11-14 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065235-001 CEFPROZIL 250MG TABLET / ORAL AB 2005-11-14 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065235-002 CEFPROZIL 500MG TABLET / ORAL AB 2005-11-14 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065235-001 CEFPROZIL 250MG TABLET / ORAL AB 2005-11-14 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065235-002 CEFPROZIL 500MG TABLET / ORAL AB 2005-11-14 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065235-001 CEFPROZIL 250MG TABLET / ORAL AB 2005-11-14 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065235-002 CEFPROZIL 500MG TABLET / ORAL AB 2005-11-14 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065235-001 CEFPROZIL 250MG TABLET / ORAL AB 2005-11-14 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065235-002 CEFPROZIL 500MG TABLET / ORAL AB 2005-11-14 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065235-001 CEFPROZIL 250MG TABLET / ORAL AB 2005-11-14 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065235-002 CEFPROZIL 500MG TABLET / ORAL AB 2005-11-14 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A065235-001 CEFPROZIL 250MG TABLET / ORAL AB 2005-11-14 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A065235-002 CEFPROZIL 500MG TABLET / ORAL AB 2005-11-14 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065235-001 CEFPROZIL 250MG TABLET / ORAL AB 2005-11-14 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065235-002 CEFPROZIL 500MG TABLET / ORAL AB 2005-11-14 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065235-001 CEFPROZIL 250MG TABLET / ORAL AB 2005-11-14 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065235-002 CEFPROZIL 500MG TABLET / ORAL AB 2005-11-14 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A065235-001 CEFPROZIL 250MG TABLET / ORAL AB 2005-11-14 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A065235-002 CEFPROZIL 500MG TABLET / ORAL AB 2005-11-14 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A065235-001 CEFPROZIL 250MG TABLET / ORAL AB 2005-11-14 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A065235-002 CEFPROZIL 500MG TABLET / ORAL AB 2005-11-14 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A065235-001 CEFPROZIL 250MG TABLET / ORAL AB 2005-11-14 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A065235-002 CEFPROZIL 500MG TABLET / ORAL AB 2005-11-14 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A065235-001 CEFPROZIL 250MG TABLET / ORAL AB 2005-11-14 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A065235-002 CEFPROZIL 500MG TABLET / ORAL AB 2005-11-14 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A065235-001 CEFPROZIL 250MG TABLET / ORAL AB 2005-11-14 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A065235-002 CEFPROZIL 500MG TABLET / ORAL AB 2005-11-14 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A065235-001 CEFPROZIL 250MG TABLET / ORAL AB 2005-11-14 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A065235-002 CEFPROZIL 500MG TABLET / ORAL AB 2005-11-14 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A065235-001 CEFPROZIL 250MG TABLET / ORAL AB 2005-11-14 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A065235-002 CEFPROZIL 500MG TABLET / ORAL AB 2005-11-14 bb7c543d1eb4…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 84 observed states.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded CEFPROZIL ACTIVE INGREDIENT 4W0459ZA4V CEFPROZIL TABLET, FILM COATED CEFPROZIL POWDER, FOR SUSPENSION [SANDOZ INC] 11 CEFPROZIL ANHYDROUS ACTIVE MOIETY 1M698F4H4E CEFPROZIL TABLET, FILM COATED CEFPROZIL POWDER, FOR SUSPENSION [SANDOZ INC] 11 .ALPHA.-TOCOPHEROL, DL- INACTIVE INGREDIENT 7QWA1RIO01 CEFPROZIL TABLET, FILM COATED CEFPROZIL POWDER, FOR SUSPENSION [SANDOZ INC] 11 ANHYDROUS CITRIC ACID INACTIVE INGREDIENT XF417D3PSL CEFPROZIL TABLET, FILM COATED CEFPROZIL POWDER, FOR SUSPENSION [SANDOZ INC] 11 ASPARTAME INACTIVE INGREDIENT Z0H242BBR1 CEFPROZIL TABLET, FILM COATED CEFPROZIL POWDER, FOR SUSPENSION [SANDOZ INC] 11 BENZYL ALCOHOL INACTIVE INGREDIENT LKG8494WBH CEFPROZIL TABLET, FILM COATED CEFPROZIL POWDER, FOR SUSPENSION [SANDOZ INC] 11 CARBOXYMETHYLCELLULOSE SODIUM INACTIVE INGREDIENT K679OBS311 CEFPROZIL TABLET, FILM COATED CEFPROZIL POWDER, FOR SUSPENSION [SANDOZ INC] 11 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U CEFPROZIL TABLET, FILM COATED CEFPROZIL POWDER, FOR SUSPENSION [SANDOZ INC] 11 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 CEFPROZIL TABLET, FILM COATED CEFPROZIL POWDER, FOR SUSPENSION [SANDOZ INC] 11 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT CEFPROZIL TABLET, FILM COATED CEFPROZIL POWDER, FOR SUSPENSION [SANDOZ INC] 11 GLYCINE INACTIVE INGREDIENT TE7660XO1C CEFPROZIL TABLET, FILM COATED CEFPROZIL POWDER, FOR SUSPENSION [SANDOZ INC] 11 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO CEFPROZIL TABLET, FILM COATED CEFPROZIL POWDER, FOR SUSPENSION [SANDOZ INC] 11 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 CEFPROZIL TABLET, FILM COATED CEFPROZIL POWDER, FOR SUSPENSION [SANDOZ INC] 11 MALTODEXTRIN INACTIVE INGREDIENT 7CVR7L4A2D CEFPROZIL TABLET, FILM COATED CEFPROZIL POWDER, FOR SUSPENSION [SANDOZ INC] 11 METHYLCELLULOSE (400 MPA.S) INACTIVE INGREDIENT O0GN6F9B2Y CEFPROZIL TABLET, FILM COATED CEFPROZIL POWDER, FOR SUSPENSION [SANDOZ INC] 11 POLYETHYLENE GLYCOL 400 INACTIVE INGREDIENT B697894SGQ CEFPROZIL TABLET, FILM COATED CEFPROZIL POWDER, FOR SUSPENSION [SANDOZ INC] 11 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H CEFPROZIL TABLET, FILM COATED CEFPROZIL POWDER, FOR SUSPENSION [SANDOZ INC] 11 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 CEFPROZIL TABLET, FILM COATED CEFPROZIL POWDER, FOR SUSPENSION [SANDOZ INC] 11 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 CEFPROZIL TABLET, FILM COATED CEFPROZIL POWDER, FOR SUSPENSION [SANDOZ INC] 11 SODIUM BENZOATE INACTIVE INGREDIENT OJ245FE5EU CEFPROZIL TABLET, FILM COATED CEFPROZIL POWDER, FOR SUSPENSION [SANDOZ INC] 11 SODIUM CHLORIDE INACTIVE INGREDIENT 451W47IQ8X CEFPROZIL TABLET, FILM COATED CEFPROZIL POWDER, FOR SUSPENSION [SANDOZ INC] 11 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 CEFPROZIL TABLET, FILM COATED CEFPROZIL POWDER, FOR SUSPENSION [SANDOZ INC] 11 SUCROSE INACTIVE INGREDIENT C151H8M554 CEFPROZIL TABLET, FILM COATED CEFPROZIL POWDER, FOR SUSPENSION [SANDOZ INC] 11 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP CEFPROZIL TABLET, FILM COATED CEFPROZIL POWDER, FOR SUSPENSION [SANDOZ INC] 11