Home NDC 57237-035 Cefprozil
Product NDC 57237-035
11-digit product format 572370035
Labeler code 57237
Product ID 57237-035_2288a04a-b86b-4c3b-8e12-e61531cf5b43
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Cefprozil
Dosage form POWDER, FOR SUSPENSION
Route ORAL
Labeler Rising Pharma Holdings, Inc.
Application ANDA065381
Marketing category ANDA
Marketing start 2007-01-30
Substance CEFPROZIL
Active strength 250 mg/5mL
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 A065381-001 CEFPROZIL CEFPROZIL 125MG/5ML FOR SUSPENSION / ORAL AB 2007-01-30 A065381-002 CEFPROZIL CEFPROZIL 250MG/5ML FOR SUSPENSION / ORAL AB 2007-01-30
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 A065381-001 CEFPROZIL 125MG/5ML FOR SUSPENSION / ORAL AB 2007-01-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A065381-002 CEFPROZIL 250MG/5ML FOR SUSPENSION / ORAL AB 2007-01-30 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A065381-001 CEFPROZIL 125MG/5ML FOR SUSPENSION / ORAL AB 2007-01-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A065381-002 CEFPROZIL 250MG/5ML FOR SUSPENSION / ORAL AB 2007-01-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065381-001 CEFPROZIL 125MG/5ML FOR SUSPENSION / ORAL AB 2007-01-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065381-002 CEFPROZIL 250MG/5ML FOR SUSPENSION / ORAL AB 2007-01-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A065381-001 CEFPROZIL 125MG/5ML FOR SUSPENSION / ORAL AB 2007-01-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A065381-002 CEFPROZIL 250MG/5ML FOR SUSPENSION / ORAL AB 2007-01-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065381-001 CEFPROZIL 125MG/5ML FOR SUSPENSION / ORAL AB 2007-01-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065381-002 CEFPROZIL 250MG/5ML FOR SUSPENSION / ORAL AB 2007-01-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065381-001 CEFPROZIL 125MG/5ML FOR SUSPENSION / ORAL AB 2007-01-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065381-002 CEFPROZIL 250MG/5ML FOR SUSPENSION / ORAL AB 2007-01-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065381-001 CEFPROZIL 125MG/5ML FOR SUSPENSION / ORAL AB 2007-01-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065381-002 CEFPROZIL 250MG/5ML FOR SUSPENSION / ORAL AB 2007-01-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065381-001 CEFPROZIL 125MG/5ML FOR SUSPENSION / ORAL AB 2007-01-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065381-002 CEFPROZIL 250MG/5ML FOR SUSPENSION / ORAL AB 2007-01-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065381-001 CEFPROZIL 125MG/5ML FOR SUSPENSION / ORAL AB 2007-01-30 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065381-002 CEFPROZIL 250MG/5ML FOR SUSPENSION / ORAL AB 2007-01-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065381-001 CEFPROZIL 125MG/5ML FOR SUSPENSION / ORAL AB 2007-01-30 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065381-002 CEFPROZIL 250MG/5ML FOR SUSPENSION / ORAL AB 2007-01-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A065381-001 CEFPROZIL 125MG/5ML FOR SUSPENSION / ORAL AB 2007-01-30 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A065381-002 CEFPROZIL 250MG/5ML FOR SUSPENSION / ORAL AB 2007-01-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065381-001 CEFPROZIL 125MG/5ML FOR SUSPENSION / ORAL AB 2007-01-30 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065381-002 CEFPROZIL 250MG/5ML FOR SUSPENSION / ORAL AB 2007-01-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065381-001 CEFPROZIL 125MG/5ML FOR SUSPENSION / ORAL AB 2007-01-30 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065381-002 CEFPROZIL 250MG/5ML FOR SUSPENSION / ORAL AB 2007-01-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A065381-001 CEFPROZIL 125MG/5ML FOR SUSPENSION / ORAL AB 2007-01-30 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A065381-002 CEFPROZIL 250MG/5ML FOR SUSPENSION / ORAL AB 2007-01-30 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A065381-001 CEFPROZIL 125MG/5ML FOR SUSPENSION / ORAL AB 2007-01-30 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A065381-002 CEFPROZIL 250MG/5ML FOR SUSPENSION / ORAL AB 2007-01-30 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A065381-001 CEFPROZIL 125MG/5ML FOR SUSPENSION / ORAL AB 2007-01-30 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A065381-002 CEFPROZIL 250MG/5ML FOR SUSPENSION / ORAL AB 2007-01-30 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A065381-001 CEFPROZIL 125MG/5ML FOR SUSPENSION / ORAL AB 2007-01-30 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A065381-002 CEFPROZIL 250MG/5ML FOR SUSPENSION / ORAL AB 2007-01-30 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A065381-001 CEFPROZIL 125MG/5ML FOR SUSPENSION / ORAL AB 2007-01-30 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A065381-002 CEFPROZIL 250MG/5ML FOR SUSPENSION / ORAL AB 2007-01-30 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A065381-001 CEFPROZIL 125MG/5ML FOR SUSPENSION / ORAL AB 2007-01-30 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A065381-002 CEFPROZIL 250MG/5ML FOR SUSPENSION / ORAL AB 2007-01-30 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A065381-001 CEFPROZIL 125MG/5ML FOR SUSPENSION / ORAL AB 2007-01-30 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A065381-002 CEFPROZIL 250MG/5ML FOR SUSPENSION / ORAL AB 2007-01-30 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/5mL
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 309080 Internal RxNorm lookup 309081 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 57237-035-01 Cefprozil 100 mL in 1 BOTTLE POWDER, FOR SUSPENSION 100 7 57237-035-50 Cefprozil 50 mL in 1 BOTTLE POWDER, FOR SUSPENSION 50 7 57237-035-75 Cefprozil 75 mL in 1 BOTTLE POWDER, FOR SUSPENSION 75 7
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded CEFPROZIL ACTIVE INGREDIENT 4W0459ZA4V CEFPROZIL POWDER, FOR SUSPENSION [CITRON PHARMA LLC] 1 CEFPROZIL ANHYDROUS ACTIVE MOIETY 1M698F4H4E CEFPROZIL POWDER, FOR SUSPENSION [CITRON PHARMA LLC] 1 ASPARTAME INACTIVE INGREDIENT Z0H242BBR1 CEFPROZIL POWDER, FOR SUSPENSION [CITRON PHARMA LLC] 1 CARBOXYMETHYLCELLULOSE SODIUM INACTIVE INGREDIENT K679OBS311 CEFPROZIL POWDER, FOR SUSPENSION [CITRON PHARMA LLC] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U CEFPROZIL POWDER, FOR SUSPENSION [CITRON PHARMA LLC] 1 CITRIC ACID MONOHYDRATE INACTIVE INGREDIENT 2968PHW8QP CEFPROZIL POWDER, FOR SUSPENSION [CITRON PHARMA LLC] 1 DIMETHICONE INACTIVE INGREDIENT 92RU3N3Y1O CEFPROZIL POWDER, FOR SUSPENSION [CITRON PHARMA LLC] 1 FD&C RED NO. 3 INACTIVE INGREDIENT PN2ZH5LOQY CEFPROZIL POWDER, FOR SUSPENSION [CITRON PHARMA LLC] 1 GLYCINE INACTIVE INGREDIENT TE7660XO1C CEFPROZIL POWDER, FOR SUSPENSION [CITRON PHARMA LLC] 1 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H CEFPROZIL POWDER, FOR SUSPENSION [CITRON PHARMA LLC] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 CEFPROZIL POWDER, FOR SUSPENSION [CITRON PHARMA LLC] 1 SODIUM BENZOATE INACTIVE INGREDIENT OJ245FE5EU CEFPROZIL POWDER, FOR SUSPENSION [CITRON PHARMA LLC] 1 SODIUM CHLORIDE INACTIVE INGREDIENT 451W47IQ8X CEFPROZIL POWDER, FOR SUSPENSION [CITRON PHARMA LLC] 1 SUCROSE INACTIVE INGREDIENT C151H8M554 CEFPROZIL POWDER, FOR SUSPENSION [CITRON PHARMA LLC] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 57237-035 CEFPROZIL POWDER, FOR SUSPENSION [RISING PHARMA HOLDINGS, INC.] 7 Current NDC, Legacy NDC, 3 package rows 20240524_d7fac9cc-30e1-4762-a01b-04f1bd3b2a56.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 Units Marketing start Marketing end Sample Exclude flag Status 57237-035-01 57237003501 100 mL in 1 BOTTLE (57237-035-01) 100 ml 2007-01-30 0000-00-00 No No Current 57237-035-50 57237003550 50 mL in 1 BOTTLE (57237-035-50) 50 ml 2007-01-30 0000-00-00 No No Current 57237-035-75 57237003575 75 mL in 1 BOTTLE (57237-035-75) 75 ml 2007-01-30 0000-00-00 No No Current