Home NDC 67253-231 Cefprozil
Product NDC 67253-231
11-digit product format 672530231
Labeler code 67253
Product ID 67253-231_f955de50-1f07-4079-9c2c-bd23ef54fd70
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Cefprozil
Dosage form TABLET, FILM COATED
Route ORAL
Labeler DAVA Pharmaceuticals Inc
Application ANDA065235
Marketing category ANDA
Marketing start 2014-08-01
Marketing end 2020-10-31
Substance CEFPROZIL
Active strength 250 mg/1
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 · 24 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 67253-231-10 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 67253-231-10 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 67253-231-10 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 67253-231-10 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 67253-231-10 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 67253-231-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 67253-231-10 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 67253-231-10 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 67253-231-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 67253-231-10 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 67253-231-10 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 67253-231-10 557ba5c1ecfa…9c80585c8c6e…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 · 82 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 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…2021-12-28 21:50 UTC 2021-12 A065235-001 CEFPROZIL 250MG TABLET / ORAL AB 2005-11-14 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A065235-002 CEFPROZIL 500MG TABLET / ORAL AB 2005-11-14 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 82 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 [DAVA PHARMACEUTICALS INC] 10 CEFPROZIL ANHYDROUS ACTIVE MOIETY 1M698F4H4E CEFPROZIL TABLET, FILM COATED CEFPROZIL POWDER, FOR SUSPENSION [DAVA PHARMACEUTICALS INC] 10 .ALPHA.-TOCOPHEROL, DL- INACTIVE INGREDIENT 7QWA1RIO01 CEFPROZIL TABLET, FILM COATED CEFPROZIL POWDER, FOR SUSPENSION [DAVA PHARMACEUTICALS INC] 10 ANHYDROUS CITRIC ACID INACTIVE INGREDIENT XF417D3PSL CEFPROZIL TABLET, FILM COATED CEFPROZIL POWDER, FOR SUSPENSION [DAVA PHARMACEUTICALS INC] 10 ASPARTAME INACTIVE INGREDIENT Z0H242BBR1 CEFPROZIL TABLET, FILM COATED CEFPROZIL POWDER, FOR SUSPENSION [DAVA PHARMACEUTICALS INC] 10 BENZYL ALCOHOL INACTIVE INGREDIENT LKG8494WBH CEFPROZIL TABLET, FILM COATED CEFPROZIL POWDER, FOR SUSPENSION [DAVA PHARMACEUTICALS INC] 10 CARBOXYMETHYLCELLULOSE SODIUM INACTIVE INGREDIENT K679OBS311 CEFPROZIL TABLET, FILM COATED CEFPROZIL POWDER, FOR SUSPENSION [DAVA PHARMACEUTICALS INC] 10 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U CEFPROZIL TABLET, FILM COATED CEFPROZIL POWDER, FOR SUSPENSION [DAVA PHARMACEUTICALS INC] 10 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 CEFPROZIL TABLET, FILM COATED CEFPROZIL POWDER, FOR SUSPENSION [DAVA PHARMACEUTICALS INC] 10 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 CEFPROZIL TABLET, FILM COATED CEFPROZIL POWDER, FOR SUSPENSION [DAVA PHARMACEUTICALS INC] 10 GLYCINE INACTIVE INGREDIENT TE7660XO1C CEFPROZIL TABLET, FILM COATED CEFPROZIL POWDER, FOR SUSPENSION [DAVA PHARMACEUTICALS INC] 10 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO CEFPROZIL TABLET, FILM COATED CEFPROZIL POWDER, FOR SUSPENSION [DAVA PHARMACEUTICALS INC] 10 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 CEFPROZIL TABLET, FILM COATED CEFPROZIL POWDER, FOR SUSPENSION [DAVA PHARMACEUTICALS INC] 10 MALTODEXTRIN INACTIVE INGREDIENT 7CVR7L4A2D CEFPROZIL TABLET, FILM COATED CEFPROZIL POWDER, FOR SUSPENSION [DAVA PHARMACEUTICALS INC] 10 METHYLCELLULOSE (400 MPA.S) INACTIVE INGREDIENT O0GN6F9B2Y CEFPROZIL TABLET, FILM COATED CEFPROZIL POWDER, FOR SUSPENSION [DAVA PHARMACEUTICALS INC] 10 POLYETHYLENE GLYCOL 400 INACTIVE INGREDIENT B697894SGQ CEFPROZIL TABLET, FILM COATED CEFPROZIL POWDER, FOR SUSPENSION [DAVA PHARMACEUTICALS INC] 10 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H CEFPROZIL TABLET, FILM COATED CEFPROZIL POWDER, FOR SUSPENSION [DAVA PHARMACEUTICALS INC] 10 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 CEFPROZIL TABLET, FILM COATED CEFPROZIL POWDER, FOR SUSPENSION [DAVA PHARMACEUTICALS INC] 10 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 CEFPROZIL TABLET, FILM COATED CEFPROZIL POWDER, FOR SUSPENSION [DAVA PHARMACEUTICALS INC] 10 SODIUM BENZOATE INACTIVE INGREDIENT OJ245FE5EU CEFPROZIL TABLET, FILM COATED CEFPROZIL POWDER, FOR SUSPENSION [DAVA PHARMACEUTICALS INC] 10 SODIUM CHLORIDE INACTIVE INGREDIENT 451W47IQ8X CEFPROZIL TABLET, FILM COATED CEFPROZIL POWDER, FOR SUSPENSION [DAVA PHARMACEUTICALS INC] 10 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 CEFPROZIL TABLET, FILM COATED CEFPROZIL POWDER, FOR SUSPENSION [DAVA PHARMACEUTICALS INC] 10 SUCROSE INACTIVE INGREDIENT C151H8M554 CEFPROZIL TABLET, FILM COATED CEFPROZIL POWDER, FOR SUSPENSION [DAVA PHARMACEUTICALS INC] 10 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP CEFPROZIL TABLET, FILM COATED CEFPROZIL POWDER, FOR SUSPENSION [DAVA PHARMACEUTICALS INC] 10