Home NDC 16714-396 Cefprozil
Product NDC 16714-396
11-digit product format 167140396
Labeler code 16714
Product ID 16714-396_f8a7ccea-370c-4afe-92f2-2f4bcc925669
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Cefprozil
Dosage form POWDER, FOR SUSPENSION
Route ORAL
Labeler NorthStar Rx LLC
Application ANDA065381
Marketing category ANDA
Marketing start 2007-01-30
Substance CEFPROZIL
Active strength 125 mg/5mL
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes 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 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
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 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CEFPROZIL 125 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 16714-396-01 Cefprozil 50 mL in 1 BOTTLE POWDER, FOR SUSPENSION 50 8 16714-396-02 Cefprozil 75 mL in 1 BOTTLE POWDER, FOR SUSPENSION 75 8 16714-396-03 Cefprozil 100 mL in 1 BOTTLE POWDER, FOR SUSPENSION 100 8
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded CEFPROZIL ACTIVE INGREDIENT 4W0459ZA4V CEFPROZIL POWDER, FOR SUSPENSION [NORTHSTAR RX LLC] 1 CEFPROZIL ANHYDROUS ACTIVE MOIETY 1M698F4H4E CEFPROZIL POWDER, FOR SUSPENSION [NORTHSTAR RX LLC] 1 ASPARTAME INACTIVE INGREDIENT Z0H242BBR1 CEFPROZIL POWDER, FOR SUSPENSION [NORTHSTAR RX LLC] 1 CARBOXYMETHYLCELLULOSE SODIUM INACTIVE INGREDIENT K679OBS311 CEFPROZIL POWDER, FOR SUSPENSION [NORTHSTAR RX LLC] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U CEFPROZIL POWDER, FOR SUSPENSION [NORTHSTAR RX LLC] 1 CITRIC ACID MONOHYDRATE INACTIVE INGREDIENT 2968PHW8QP CEFPROZIL POWDER, FOR SUSPENSION [NORTHSTAR RX LLC] 1 COLLOIDAL SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 CEFPROZIL POWDER, FOR SUSPENSION [NORTHSTAR RX LLC] 1 DIMETHICONE INACTIVE INGREDIENT 92RU3N3Y1O CEFPROZIL POWDER, FOR SUSPENSION [NORTHSTAR RX LLC] 1 FD&C RED NO. 3 INACTIVE INGREDIENT PN2ZH5LOQY CEFPROZIL POWDER, FOR SUSPENSION [NORTHSTAR RX LLC] 1 GLYCINE INACTIVE INGREDIENT TE7660XO1C CEFPROZIL POWDER, FOR SUSPENSION [NORTHSTAR RX LLC] 1 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H CEFPROZIL POWDER, FOR SUSPENSION [NORTHSTAR RX LLC] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 CEFPROZIL POWDER, FOR SUSPENSION [NORTHSTAR RX LLC] 1 SODIUM BENZOATE INACTIVE INGREDIENT OJ245FE5EU CEFPROZIL POWDER, FOR SUSPENSION [NORTHSTAR RX LLC] 1 SODIUM CHLORIDE INACTIVE INGREDIENT 451W47IQ8X CEFPROZIL POWDER, FOR SUSPENSION [NORTHSTAR RX LLC] 1 SUCROSE INACTIVE INGREDIENT C151H8M554 CEFPROZIL POWDER, FOR SUSPENSION [NORTHSTAR RX LLC] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 16714-396 CEFPROZIL POWDER, FOR SUSPENSION [NORTHSTAR RX LLC] 8 Current NDC, Legacy NDC, 3 package rows 20240521_8e3943b5-8c30-4c81-bcfa-aeaaa1d75fb4.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 16714-396-01 16714039601 50 mL in 1 BOTTLE (16714-396-01) 50 ml 2007-01-30 0000-00-00 No No Current 16714-396-02 16714039602 75 mL in 1 BOTTLE (16714-396-02) 75 ml 2007-01-30 0000-00-00 No No Current 16714-396-03 16714039603 100 mL in 1 BOTTLE (16714-396-03) 100 ml 2007-01-30 0000-00-00 No No Current