Home NDC 68180-402 CEFPROZIL
Product NDC 68180-402
11-digit product format 681800402
Labeler code 68180
Product ID 68180-402_45d1a412-407b-48d4-be64-b9c7ec3c5205
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 2005-12-01
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 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 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 68180-402-01 CEFPROZIL 50 mL in 1 BOTTLE POWDER, FOR SUSPENSION 50 9 68180-402-02 CEFPROZIL 75 mL in 1 BOTTLE POWDER, FOR SUSPENSION 75 9 68180-402-03 CEFPROZIL 100 mL in 1 BOTTLE POWDER, FOR SUSPENSION 100 9
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded CEFPROZIL ACTIVE INGREDIENT 4W0459ZA4V CEFPROZIL (CEFPROZIL) POWDER, FOR SUSPENSION [LUPIN PHARMACEUTICALS INC] 2 CEFPROZIL ACTIVE MOIETY 4W0459ZA4V CEFPROZIL (CEFPROZIL) POWDER, FOR SUSPENSION [LUPIN PHARMACEUTICALS INC] 2 ANHYDROUS CITRIC ACID INACTIVE INGREDIENT XF417D3PSL CEFPROZIL (CEFPROZIL) POWDER, FOR SUSPENSION [LUPIN PHARMACEUTICALS INC] 2 ASPARTAME INACTIVE INGREDIENT Z0H242BBR1 CEFPROZIL (CEFPROZIL) POWDER, FOR SUSPENSION [LUPIN PHARMACEUTICALS INC] 2 CARBOXYMETHYLCELLULOSE SODIUM INACTIVE INGREDIENT K679OBS311 CEFPROZIL (CEFPROZIL) POWDER, FOR SUSPENSION [LUPIN PHARMACEUTICALS INC] 2 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U CEFPROZIL (CEFPROZIL) POWDER, FOR SUSPENSION [LUPIN PHARMACEUTICALS INC] 2 COLLOIDAL SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 CEFPROZIL (CEFPROZIL) POWDER, FOR SUSPENSION [LUPIN PHARMACEUTICALS INC] 2 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA CEFPROZIL (CEFPROZIL) POWDER, FOR SUSPENSION [LUPIN PHARMACEUTICALS INC] 2 GLYCINE INACTIVE INGREDIENT TE7660XO1C CEFPROZIL (CEFPROZIL) POWDER, FOR SUSPENSION [LUPIN PHARMACEUTICALS INC] 2 SODIUM BENZOATE INACTIVE INGREDIENT OJ245FE5EU CEFPROZIL (CEFPROZIL) POWDER, FOR SUSPENSION [LUPIN PHARMACEUTICALS INC] 2 SODIUM CHLORIDE INACTIVE INGREDIENT 451W47IQ8X CEFPROZIL (CEFPROZIL) POWDER, FOR SUSPENSION [LUPIN PHARMACEUTICALS INC] 2 SUCROSE INACTIVE INGREDIENT C151H8M554 CEFPROZIL (CEFPROZIL) POWDER, FOR SUSPENSION [LUPIN PHARMACEUTICALS INC] 2 CEFPROZIL ACTIVE INGREDIENT 4W0459ZA4V CEFPROZIL POWDER, FOR SUSPENSION [PHYSICIANS TOTAL CARE, INC.] 1 CEFPROZIL ACTIVE MOIETY 4W0459ZA4V CEFPROZIL POWDER, FOR SUSPENSION [PHYSICIANS TOTAL CARE, INC.] 1 ANHYDROUS CITRIC ACID INACTIVE INGREDIENT XF417D3PSL CEFPROZIL POWDER, FOR SUSPENSION [PHYSICIANS TOTAL CARE, INC.] 1 ASPARTAME INACTIVE INGREDIENT Z0H242BBR1 CEFPROZIL POWDER, FOR SUSPENSION [PHYSICIANS TOTAL CARE, INC.] 1 CARBOXYMETHYLCELLULOSE SODIUM INACTIVE INGREDIENT K679OBS311 CEFPROZIL POWDER, FOR SUSPENSION [PHYSICIANS TOTAL CARE, INC.] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U CEFPROZIL POWDER, FOR SUSPENSION [PHYSICIANS TOTAL CARE, INC.] 1 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA CEFPROZIL POWDER, FOR SUSPENSION [PHYSICIANS TOTAL CARE, INC.] 1 GLYCINE INACTIVE INGREDIENT TE7660XO1C CEFPROZIL POWDER, FOR SUSPENSION [PHYSICIANS TOTAL CARE, INC.] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 CEFPROZIL POWDER, FOR SUSPENSION [PHYSICIANS TOTAL CARE, INC.] 1 SODIUM BENZOATE INACTIVE INGREDIENT OJ245FE5EU CEFPROZIL POWDER, FOR SUSPENSION [PHYSICIANS TOTAL CARE, INC.] 1 SODIUM CHLORIDE INACTIVE INGREDIENT 451W47IQ8X CEFPROZIL POWDER, FOR SUSPENSION [PHYSICIANS TOTAL CARE, INC.] 1 SUCROSE INACTIVE INGREDIENT C151H8M554 CEFPROZIL POWDER, FOR SUSPENSION [PHYSICIANS TOTAL CARE, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68180-402 CEFPROZIL POWDER, FOR SUSPENSION [LUPIN PHARMACEUTICALS, INC.] 8 Current NDC, Legacy NDC, 3 package rows 20250130_3ec55c0a-1456-412e-972f-352b3135c8f2.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 · 2 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 68180-402-01 68180040201 50 mL in 1 BOTTLE (68180-402-01) 50 ml 2005-12-01 0000-00-00 No No Current 68180-402-02 68180040202 75 mL in 1 BOTTLE (68180-402-02) 75 ml 2005-12-01 0000-00-00 No No Current 68180-402-03 68180040203 100 mL in 1 BOTTLE (68180-402-03) 100 ml 2005-12-01 0000-00-00 No No Current