Home NDC 67877-244 Cefprozil
Product NDC 67877-244
11-digit product format 678770244
Labeler code 67877
Product ID 67877-244_2e36bf51-2cc6-441a-ad40-6d752e3e4e9b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Cefprozil
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Ascend Laboratories, LLC
Application ANDA090857
Marketing category ANDA
Marketing start 2025-01-20
Substance CEFPROZIL
Active strength 250 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 A090857-001 CEFPROZIL CEFPROZIL 250MG TABLET / ORAL AB 2024-04-09 A090857-002 CEFPROZIL CEFPROZIL 500MG TABLET / ORAL AB 2024-04-09
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.
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 A090857-001 CEFPROZIL 250MG TABLET / ORAL AB 2024-04-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A090857-002 CEFPROZIL 500MG TABLET / ORAL AB 2024-04-09 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A090857-001 CEFPROZIL 250MG TABLET / ORAL AB 2024-04-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A090857-002 CEFPROZIL 500MG TABLET / ORAL AB 2024-04-09 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090857-001 CEFPROZIL 250MG TABLET / ORAL AB 2024-04-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090857-002 CEFPROZIL 500MG TABLET / ORAL AB 2024-04-09 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A090857-001 CEFPROZIL 250MG TABLET / ORAL AB 2024-04-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A090857-002 CEFPROZIL 500MG TABLET / ORAL AB 2024-04-09 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090857-001 CEFPROZIL 250MG TABLET / ORAL AB 2024-04-09 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090857-002 CEFPROZIL 500MG TABLET / ORAL AB 2024-04-09 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090857-001 CEFPROZIL 250MG TABLET / ORAL AB 2024-04-09 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090857-002 CEFPROZIL 500MG TABLET / ORAL AB 2024-04-09 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090857-001 CEFPROZIL 250MG TABLET / ORAL AB 2024-04-09 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090857-002 CEFPROZIL 500MG TABLET / ORAL AB 2024-04-09 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090857-001 CEFPROZIL 250MG TABLET / ORAL AB 2024-04-09 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090857-002 CEFPROZIL 500MG TABLET / ORAL AB 2024-04-09 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090857-001 CEFPROZIL 250MG TABLET / ORAL AB 2024-04-09 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090857-002 CEFPROZIL 500MG TABLET / ORAL AB 2024-04-09 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090857-001 CEFPROZIL 250MG TABLET / ORAL AB 2024-04-09 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090857-002 CEFPROZIL 500MG TABLET / ORAL AB 2024-04-09 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A090857-001 CEFPROZIL 250MG TABLET / ORAL AB 2024-04-09 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A090857-002 CEFPROZIL 500MG TABLET / ORAL AB 2024-04-09 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090857-001 CEFPROZIL 250MG TABLET / ORAL AB 2024-04-09 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090857-002 CEFPROZIL 500MG TABLET / ORAL AB 2024-04-09 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A090857-001 CEFPROZIL 250MG TABLET / ORAL AB 2024-04-09 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A090857-002 CEFPROZIL 500MG TABLET / ORAL AB 2024-04-09 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A090857-001 CEFPROZIL 250MG TABLET / ORAL AB 2024-04-09 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A090857-002 CEFPROZIL 500MG TABLET / ORAL AB 2024-04-09 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A090857-001 CEFPROZIL 250MG TABLET / ORAL AB 2024-04-09 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A090857-002 CEFPROZIL 500MG TABLET / ORAL AB 2024-04-09 8072bd15b7f6…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A090857-001 CEFPROZIL 250MG TABLET / ORAL AB 2024-04-09 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A090857-002 CEFPROZIL 500MG TABLET / ORAL AB 2024-04-09 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Cefprozil
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CEFPROZIL 250 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 67877-244-01 Cefprozil 100 in 1 BOTTLE TABLET, FILM COATED 100 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 67877-244 CEFPROZIL TABLET, FILM COATED [ASCEND LABORATORIES, LLC] 5 Current NDC, 1 package rows 20250131_dc3e9cae-6f4f-4045-a11e-2fbf7f94c3c0.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 Sample Exclude flag Status 67877-244-01 67877024401 100 TABLET, FILM COATED in 1 BOTTLE (67877-244-01) 2025-01-20 No No Current