Home NDC 68180-273 CEFPROZIL
Product NDC 68180-273
11-digit product format 681800273
Labeler code 68180
Product ID 68180-273_f2cfb43d-9704-49ca-8eae-97327e62044d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name cefprozil
Dosage form POWDER, FOR SUSPENSION
Route ORAL
Labeler Lupin Pharmaceuticals, Inc.
Application ANDA065261
Marketing category ANDA
Marketing start 2026-05-04
Substance CEFPROZIL
Active strength 250 mg/5mL
NDC exclude flag No
Listing certified through 2027-12-31
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 A065261-001 CEFPROZIL CEFPROZIL 125MG/5ML FOR SUSPENSION / ORAL AB 2005-12-19 A065261-002 CEFPROZIL CEFPROZIL 250MG/5ML FOR SUSPENSION / ORAL AB RS 2005-12-19
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 A065261-001 CEFPROZIL 125MG/5ML FOR SUSPENSION / ORAL AB 2005-12-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A065261-002 CEFPROZIL 250MG/5ML FOR SUSPENSION / ORAL AB RS 2005-12-19 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A065261-001 CEFPROZIL 125MG/5ML FOR SUSPENSION / ORAL AB 2005-12-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A065261-002 CEFPROZIL 250MG/5ML FOR SUSPENSION / ORAL AB RS 2005-12-19 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065261-001 CEFPROZIL 125MG/5ML FOR SUSPENSION / ORAL AB 2005-12-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065261-002 CEFPROZIL 250MG/5ML FOR SUSPENSION / ORAL AB RS 2005-12-19 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A065261-001 CEFPROZIL 125MG/5ML FOR SUSPENSION / ORAL AB 2005-12-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A065261-002 CEFPROZIL 250MG/5ML FOR SUSPENSION / ORAL AB RS 2005-12-19 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065261-001 CEFPROZIL 125MG/5ML FOR SUSPENSION / ORAL AB 2005-12-19 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065261-002 CEFPROZIL 250MG/5ML FOR SUSPENSION / ORAL AB RS 2005-12-19 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065261-001 CEFPROZIL 125MG/5ML FOR SUSPENSION / ORAL AB 2005-12-19 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065261-002 CEFPROZIL 250MG/5ML FOR SUSPENSION / ORAL AB RS 2005-12-19 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065261-001 CEFPROZIL 125MG/5ML FOR SUSPENSION / ORAL AB 2005-12-19 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065261-002 CEFPROZIL 250MG/5ML FOR SUSPENSION / ORAL AB RS 2005-12-19 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065261-001 CEFPROZIL 125MG/5ML FOR SUSPENSION / ORAL AB 2005-12-19 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065261-002 CEFPROZIL 250MG/5ML FOR SUSPENSION / ORAL AB RS 2005-12-19 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065261-001 CEFPROZIL 125MG/5ML FOR SUSPENSION / ORAL AB 2005-12-19 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065261-002 CEFPROZIL 250MG/5ML FOR SUSPENSION / ORAL AB RS 2005-12-19 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065261-001 CEFPROZIL 125MG/5ML FOR SUSPENSION / ORAL AB 2005-12-19 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065261-002 CEFPROZIL 250MG/5ML FOR SUSPENSION / ORAL AB RS 2005-12-19 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A065261-001 CEFPROZIL 125MG/5ML FOR SUSPENSION / ORAL AB 2005-12-19 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A065261-002 CEFPROZIL 250MG/5ML FOR SUSPENSION / ORAL AB RS 2005-12-19 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065261-001 CEFPROZIL 125MG/5ML FOR SUSPENSION / ORAL AB 2005-12-19 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065261-002 CEFPROZIL 250MG/5ML FOR SUSPENSION / ORAL AB RS 2005-12-19 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065261-001 CEFPROZIL 125MG/5ML FOR SUSPENSION / ORAL AB 2005-12-19 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065261-002 CEFPROZIL 250MG/5ML FOR SUSPENSION / ORAL AB RS 2005-12-19 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A065261-001 CEFPROZIL 125MG/5ML FOR SUSPENSION / ORAL AB 2005-12-19 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A065261-002 CEFPROZIL 250MG/5ML FOR SUSPENSION / ORAL AB RS 2005-12-19 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A065261-001 CEFPROZIL 125MG/5ML FOR SUSPENSION / ORAL AB 2005-12-19 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A065261-002 CEFPROZIL 250MG/5ML FOR SUSPENSION / ORAL AB RS 2005-12-19 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A065261-001 CEFPROZIL 125MG/5ML FOR SUSPENSION / ORAL AB 2005-12-19 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A065261-002 CEFPROZIL 250MG/5ML FOR SUSPENSION / ORAL AB RS 2005-12-19 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A065261-001 CEFPROZIL 125MG/5ML FOR SUSPENSION / ORAL AB 2005-12-19 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A065261-002 CEFPROZIL 250MG/5ML FOR SUSPENSION / ORAL AB RS 2005-12-19 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A065261-001 CEFPROZIL 125MG/5ML FOR SUSPENSION / ORAL AB 2005-12-19 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A065261-002 CEFPROZIL 250MG/5ML FOR SUSPENSION / ORAL AB RS 2005-12-19 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A065261-001 CEFPROZIL 125MG/5ML FOR SUSPENSION / ORAL AB 2005-12-19 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A065261-002 CEFPROZIL 250MG/5ML FOR SUSPENSION / ORAL AB RS 2005-12-19 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A065261-001 CEFPROZIL 125MG/5ML FOR SUSPENSION / ORAL AB 2005-12-19 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A065261-002 CEFPROZIL 250MG/5ML FOR SUSPENSION / ORAL AB RS 2005-12-19 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 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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 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 68180-273-01 CEFPROZIL 50 mL in 1 BOTTLE POWDER, FOR SUSPENSION 50 1 68180-273-02 CEFPROZIL 75 mL in 1 BOTTLE POWDER, FOR SUSPENSION 75 1 68180-273-03 CEFPROZIL 100 mL in 1 BOTTLE POWDER, FOR SUSPENSION 100 1
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 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 68180-273-01 68180027301 50 mL in 1 BOTTLE (68180-273-01) 50 ml 2026-05-04 No No Current 68180-273-02 68180027302 75 mL in 1 BOTTLE (68180-273-02) 75 ml 2026-05-04 No No Current 68180-273-03 68180027303 100 mL in 1 BOTTLE (68180-273-03) 100 ml 2026-05-04 No No Current