Home NDC 55700-708-20 Cefprozil
Product NDC 55700-708
Requested package NDC 55700-708-20
11-digit product format 557000708
Labeler code 55700
Product ID 55700-708_7cb4f793-fd23-4552-85df-6a8ab64cdada
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Cefprozil
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Quality Care Products, LLC
Application ANDA065208
Marketing category ANDA
Marketing start 2005-12-23
Marketing end 2021-10-31
Substance CEFPROZIL
Active strength 500 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 · 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 A065208-001 CEFPROZIL CEFPROZIL 250MG TABLET / ORAL AB 2005-12-06 A065208-002 CEFPROZIL CEFPROZIL 500MG TABLET / ORAL AB 2005-12-06
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 A065208-001 CEFPROZIL 250MG TABLET / ORAL AB 2005-12-06 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A065208-002 CEFPROZIL 500MG TABLET / ORAL AB 2005-12-06 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A065208-001 CEFPROZIL 250MG TABLET / ORAL AB 2005-12-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A065208-002 CEFPROZIL 500MG TABLET / ORAL AB 2005-12-06 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065208-001 CEFPROZIL 250MG TABLET / ORAL AB 2005-12-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065208-002 CEFPROZIL 500MG TABLET / ORAL AB 2005-12-06 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A065208-001 CEFPROZIL 250MG TABLET / ORAL AB 2005-12-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A065208-002 CEFPROZIL 500MG TABLET / ORAL AB 2005-12-06 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065208-001 CEFPROZIL 250MG TABLET / ORAL AB 2005-12-06 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065208-002 CEFPROZIL 500MG TABLET / ORAL AB 2005-12-06 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065208-001 CEFPROZIL 250MG TABLET / ORAL AB 2005-12-06 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065208-002 CEFPROZIL 500MG TABLET / ORAL AB 2005-12-06 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065208-001 CEFPROZIL 250MG TABLET / ORAL AB 2005-12-06 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065208-002 CEFPROZIL 500MG TABLET / ORAL AB 2005-12-06 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065208-001 CEFPROZIL 250MG TABLET / ORAL AB 2005-12-06 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065208-002 CEFPROZIL 500MG TABLET / ORAL AB 2005-12-06 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065208-001 CEFPROZIL 250MG TABLET / ORAL AB 2005-12-06 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065208-002 CEFPROZIL 500MG TABLET / ORAL AB 2005-12-06 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065208-001 CEFPROZIL 250MG TABLET / ORAL AB 2005-12-06 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065208-002 CEFPROZIL 500MG TABLET / ORAL AB 2005-12-06 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A065208-001 CEFPROZIL 250MG TABLET / ORAL AB 2005-12-06 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A065208-002 CEFPROZIL 500MG TABLET / ORAL AB 2005-12-06 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065208-001 CEFPROZIL 250MG TABLET / ORAL AB 2005-12-06 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065208-002 CEFPROZIL 500MG TABLET / ORAL AB 2005-12-06 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065208-001 CEFPROZIL 250MG TABLET / ORAL AB 2005-12-06 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065208-002 CEFPROZIL 500MG TABLET / ORAL AB 2005-12-06 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A065208-001 CEFPROZIL 250MG TABLET / ORAL AB 2005-12-06 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A065208-002 CEFPROZIL 500MG TABLET / ORAL AB 2005-12-06 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A065208-001 CEFPROZIL 250MG TABLET / ORAL AB 2005-12-06 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A065208-002 CEFPROZIL 500MG TABLET / ORAL AB 2005-12-06 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A065208-001 CEFPROZIL 250MG TABLET / ORAL AB 2005-12-06 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A065208-002 CEFPROZIL 500MG TABLET / ORAL AB 2005-12-06 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A065208-001 CEFPROZIL 250MG TABLET / ORAL AB 2005-12-06 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A065208-002 CEFPROZIL 500MG TABLET / ORAL AB 2005-12-06 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A065208-001 CEFPROZIL 250MG TABLET / ORAL AB 2005-12-06 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A065208-002 CEFPROZIL 500MG TABLET / ORAL AB 2005-12-06 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A065208-001 CEFPROZIL 250MG TABLET / ORAL AB 2005-12-06 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A065208-002 CEFPROZIL 500MG TABLET / ORAL AB 2005-12-06 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A065208-001 CEFPROZIL 250MG TABLET / ORAL AB 2005-12-06 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A065208-002 CEFPROZIL 500MG TABLET / ORAL AB 2005-12-06 bb7c543d1eb4…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 84 observed states.
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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Cefprozil CEFPROZIL Teva Pharmaceuticals USA, Inc. 3391de8b-7bc9-4624-a5c4-836135b39d99 2018-08-31 Warnings, Adverse reactions Exact identifier application applno (ANDA): 065208 application number: ANDA065208
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 55700-708-20 55700070820 20 TABLET, FILM COATED in 1 BOTTLE (55700-708-20) 2018-12-14 2021-10-31 No No Current