Home NDC 57237-036 Cefprozil
Product NDC 57237-036
11-digit product format 572370036
Labeler code 57237
Product ID 57237-036_ccfc6236-d155-4a97-8cbf-a5d4592e677f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Cefprozil
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Rising Pharma Holdings, Inc.
Application ANDA065340
Marketing category ANDA
Marketing start 2007-05-24
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 A065340-001 CEFPROZIL CEFPROZIL 250MG TABLET / ORAL AB 2007-05-24 A065340-002 CEFPROZIL CEFPROZIL 500MG TABLET / ORAL AB 2007-05-24
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 A065340-001 CEFPROZIL 250MG TABLET / ORAL AB 2007-05-24 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A065340-002 CEFPROZIL 500MG TABLET / ORAL AB 2007-05-24 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A065340-001 CEFPROZIL 250MG TABLET / ORAL AB 2007-05-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A065340-002 CEFPROZIL 500MG TABLET / ORAL AB 2007-05-24 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065340-001 CEFPROZIL 250MG TABLET / ORAL AB 2007-05-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065340-002 CEFPROZIL 500MG TABLET / ORAL AB 2007-05-24 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A065340-001 CEFPROZIL 250MG TABLET / ORAL AB 2007-05-24 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A065340-002 CEFPROZIL 500MG TABLET / ORAL AB 2007-05-24 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065340-001 CEFPROZIL 250MG TABLET / ORAL AB 2007-05-24 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065340-002 CEFPROZIL 500MG TABLET / ORAL AB 2007-05-24 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065340-001 CEFPROZIL 250MG TABLET / ORAL AB 2007-05-24 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065340-002 CEFPROZIL 500MG TABLET / ORAL AB 2007-05-24 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065340-001 CEFPROZIL 250MG TABLET / ORAL AB 2007-05-24 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065340-002 CEFPROZIL 500MG TABLET / ORAL AB 2007-05-24 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065340-001 CEFPROZIL 250MG TABLET / ORAL AB 2007-05-24 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065340-002 CEFPROZIL 500MG TABLET / ORAL AB 2007-05-24 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065340-001 CEFPROZIL 250MG TABLET / ORAL AB 2007-05-24 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065340-002 CEFPROZIL 500MG TABLET / ORAL AB 2007-05-24 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065340-001 CEFPROZIL 250MG TABLET / ORAL AB 2007-05-24 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065340-002 CEFPROZIL 500MG TABLET / ORAL AB 2007-05-24 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A065340-001 CEFPROZIL 250MG TABLET / ORAL AB 2007-05-24 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A065340-002 CEFPROZIL 500MG TABLET / ORAL AB 2007-05-24 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065340-001 CEFPROZIL 250MG TABLET / ORAL AB 2007-05-24 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065340-002 CEFPROZIL 500MG TABLET / ORAL AB 2007-05-24 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065340-001 CEFPROZIL 250MG TABLET / ORAL AB 2007-05-24 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065340-002 CEFPROZIL 500MG TABLET / ORAL AB 2007-05-24 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A065340-001 CEFPROZIL 250MG TABLET / ORAL AB 2007-05-24 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A065340-002 CEFPROZIL 500MG TABLET / ORAL AB 2007-05-24 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A065340-001 CEFPROZIL 250MG TABLET / ORAL AB 2007-05-24 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A065340-002 CEFPROZIL 500MG TABLET / ORAL AB 2007-05-24 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A065340-001 CEFPROZIL 250MG TABLET / ORAL AB 2007-05-24 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A065340-002 CEFPROZIL 500MG TABLET / ORAL AB 2007-05-24 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A065340-001 CEFPROZIL 250MG TABLET / ORAL AB 2007-05-24 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A065340-002 CEFPROZIL 500MG TABLET / ORAL AB 2007-05-24 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A065340-001 CEFPROZIL 250MG TABLET / ORAL AB 2007-05-24 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A065340-002 CEFPROZIL 500MG TABLET / ORAL AB 2007-05-24 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A065340-001 CEFPROZIL 250MG TABLET / ORAL AB 2007-05-24 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A065340-002 CEFPROZIL 500MG TABLET / ORAL AB 2007-05-24 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A065340-001 CEFPROZIL 250MG TABLET / ORAL AB 2007-05-24 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A065340-002 CEFPROZIL 500MG TABLET / ORAL AB 2007-05-24 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 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 57237-036-01 Cefprozil 100 in 1 BOTTLE TABLET, FILM COATED 100 7
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded CEFPROZIL ACTIVE INGREDIENT 4W0459ZA4V CEFPROZIL TABLET, FILM COATED [CITRON PHARMA LLC] 1 CEFPROZIL ANHYDROUS ACTIVE MOIETY 1M698F4H4E CEFPROZIL TABLET, FILM COATED [CITRON PHARMA LLC] 1 AMMONIA INACTIVE INGREDIENT 5138Q19F1X CEFPROZIL TABLET, FILM COATED [CITRON PHARMA LLC] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U CEFPROZIL TABLET, FILM COATED [CITRON PHARMA LLC] 1 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 CEFPROZIL TABLET, FILM COATED [CITRON PHARMA LLC] 1 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 CEFPROZIL TABLET, FILM COATED [CITRON PHARMA LLC] 1 HYPROMELLOSE 2910 (3 MPA.S) INACTIVE INGREDIENT 0VUT3PMY82 CEFPROZIL TABLET, FILM COATED [CITRON PHARMA LLC] 1 HYPROMELLOSE 2910 (5 MPA.S) INACTIVE INGREDIENT R75537T0T4 CEFPROZIL TABLET, FILM COATED [CITRON PHARMA LLC] 1 HYPROMELLOSE 2910 (6 MPA.S) INACTIVE INGREDIENT 0WZ8WG20P6 CEFPROZIL TABLET, FILM COATED [CITRON PHARMA LLC] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 CEFPROZIL TABLET, FILM COATED [CITRON PHARMA LLC] 1 POLYETHYLENE GLYCOL 400 INACTIVE INGREDIENT B697894SGQ CEFPROZIL TABLET, FILM COATED [CITRON PHARMA LLC] 1 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H CEFPROZIL TABLET, FILM COATED [CITRON PHARMA LLC] 1 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 CEFPROZIL TABLET, FILM COATED [CITRON PHARMA LLC] 1 SHELLAC INACTIVE INGREDIENT 46N107B71O CEFPROZIL TABLET, FILM COATED [CITRON PHARMA LLC] 1 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 CEFPROZIL TABLET, FILM COATED [CITRON PHARMA LLC] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP CEFPROZIL TABLET, FILM COATED [CITRON PHARMA LLC] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 57237-036 CEFPROZIL TABLET, FILM COATED [RISING PHARMA HOLDINGS, INC.] 7 Current NDC, Legacy NDC, 1 package rows 20240509_af24a86f-8072-49a6-94ec-2f17fe81812b.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 · 4 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 57237-036-01 57237003601 100 TABLET, FILM COATED in 1 BOTTLE (57237-036-01) 2007-05-24 0000-00-00 No No Current