Home NDC 68180-404 CEFPROZIL
Product NDC 68180-404
11-digit product format 681800404
Labeler code 68180
Product ID 68180-404_b5bc3f77-ca01-4c3f-b8b6-591a3d8f73f4
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name CEFPROZIL
Dosage form TABLET
Route ORAL
Labeler Lupin Pharmaceuticals, Inc.
Application ANDA065276
Marketing category ANDA
Marketing start 2005-12-01
Substance CEFPROZIL
Active strength 500 mg/1
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 · 5 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 2025-01-20 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 A065276-001 CEFPROZIL CEFPROZIL 250MG TABLET / ORAL AB 2005-12-08 A065276-002 CEFPROZIL CEFPROZIL 500MG TABLET / ORAL AB RS 2005-12-08
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 A065276-001 CEFPROZIL 250MG TABLET / ORAL AB 2005-12-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A065276-002 CEFPROZIL 500MG TABLET / ORAL AB RS 2005-12-08 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A065276-001 CEFPROZIL 250MG TABLET / ORAL AB 2005-12-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A065276-002 CEFPROZIL 500MG TABLET / ORAL AB RS 2005-12-08 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065276-001 CEFPROZIL 250MG TABLET / ORAL AB 2005-12-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065276-002 CEFPROZIL 500MG TABLET / ORAL AB RS 2005-12-08 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A065276-001 CEFPROZIL 250MG TABLET / ORAL AB 2005-12-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A065276-002 CEFPROZIL 500MG TABLET / ORAL AB RS 2005-12-08 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065276-001 CEFPROZIL 250MG TABLET / ORAL AB 2005-12-08 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065276-002 CEFPROZIL 500MG TABLET / ORAL AB RS 2005-12-08 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065276-001 CEFPROZIL 250MG TABLET / ORAL AB 2005-12-08 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065276-002 CEFPROZIL 500MG TABLET / ORAL AB RS 2005-12-08 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065276-001 CEFPROZIL 250MG TABLET / ORAL AB 2005-12-08 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065276-002 CEFPROZIL 500MG TABLET / ORAL AB RS 2005-12-08 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065276-001 CEFPROZIL 250MG TABLET / ORAL AB 2005-12-08 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065276-002 CEFPROZIL 500MG TABLET / ORAL AB RS 2005-12-08 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065276-001 CEFPROZIL 250MG TABLET / ORAL AB 2005-12-08 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065276-002 CEFPROZIL 500MG TABLET / ORAL AB RS 2005-12-08 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065276-001 CEFPROZIL 250MG TABLET / ORAL AB 2005-12-08 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065276-002 CEFPROZIL 500MG TABLET / ORAL AB RS 2005-12-08 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A065276-001 CEFPROZIL 250MG TABLET / ORAL AB 2005-12-08 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A065276-002 CEFPROZIL 500MG TABLET / ORAL AB RS 2005-12-08 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065276-001 CEFPROZIL 250MG TABLET / ORAL AB 2005-12-08 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065276-002 CEFPROZIL 500MG TABLET / ORAL AB RS 2005-12-08 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065276-001 CEFPROZIL 250MG TABLET / ORAL AB 2005-12-08 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065276-002 CEFPROZIL 500MG TABLET / ORAL AB RS 2005-12-08 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A065276-001 CEFPROZIL 250MG TABLET / ORAL AB 2005-12-08 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A065276-002 CEFPROZIL 500MG TABLET / ORAL AB RS 2005-12-08 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A065276-001 CEFPROZIL 250MG TABLET / ORAL AB 2005-12-08 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A065276-002 CEFPROZIL 500MG TABLET / ORAL AB RS 2005-12-08 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A065276-001 CEFPROZIL 250MG TABLET / ORAL AB 2005-12-08 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A065276-002 CEFPROZIL 500MG TABLET / ORAL AB RS 2005-12-08 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A065276-001 CEFPROZIL 250MG TABLET / ORAL AB 2005-12-08 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A065276-002 CEFPROZIL 500MG TABLET / ORAL AB RS 2005-12-08 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A065276-001 CEFPROZIL 250MG TABLET / ORAL AB 2005-12-08 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A065276-002 CEFPROZIL 500MG TABLET / ORAL AB RS 2005-12-08 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A065276-001 CEFPROZIL 250MG TABLET / ORAL AB 2005-12-08 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A065276-002 CEFPROZIL 500MG TABLET / ORAL AB RS 2005-12-08 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A065276-001 CEFPROZIL 250MG TABLET / ORAL AB 2005-12-08 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A065276-002 CEFPROZIL 500MG TABLET / ORAL AB RS 2005-12-08 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 500 mg/1
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 197452 Internal RxNorm lookup 197453 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 68180-404-01 CEFPROZIL 50 in 1 BOTTLE TABLET 50 10
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded CEFPROZIL ACTIVE INGREDIENT 4W0459ZA4V CEFPROZIL (CEFPROZIL) TABLET [H. J. HARKINS COMPANY, INC.] 3 CEFPROZIL ACTIVE INGREDIENT 4W0459ZA4V CEFPROZIL TABLET [LUPIN PHARMACEUTICALS, INC.] 3 CEFPROZIL ANHYDROUS ACTIVE MOIETY 1M698F4H4E CEFPROZIL (CEFPROZIL) TABLET [H. J. HARKINS COMPANY, INC.] 3 CEFPROZIL ANHYDROUS ACTIVE MOIETY 1M698F4H4E CEFPROZIL TABLET [LUPIN PHARMACEUTICALS, INC.] 3 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U CEFPROZIL (CEFPROZIL) TABLET [H. J. HARKINS COMPANY, INC.] 3 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U CEFPROZIL TABLET [LUPIN PHARMACEUTICALS, INC.] 3 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 CEFPROZIL TABLET [LUPIN PHARMACEUTICALS, INC.] 3 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 CEFPROZIL (CEFPROZIL) TABLET [H. J. HARKINS COMPANY, INC.] 3 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 CEFPROZIL TABLET [LUPIN PHARMACEUTICALS, INC.] 3 METHYLCELLULOSE (15 CPS) INACTIVE INGREDIENT NPU9M2E6L8 CEFPROZIL (CEFPROZIL) TABLET [H. J. HARKINS COMPANY, INC.] 3 METHYLCELLULOSE (15 CPS) INACTIVE INGREDIENT NPU9M2E6L8 CEFPROZIL TABLET [LUPIN PHARMACEUTICALS, INC.] 3 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 CEFPROZIL (CEFPROZIL) TABLET [H. J. HARKINS COMPANY, INC.] 3 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 CEFPROZIL TABLET [LUPIN PHARMACEUTICALS, INC.] 3 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP CEFPROZIL TABLET [LUPIN PHARMACEUTICALS, INC.] 3 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP CEFPROZIL (CEFPROZIL) TABLET [H. J. HARKINS COMPANY, INC.] 3 CEFPROZIL ACTIVE INGREDIENT 4W0459ZA4V CEFPROZIL TABLET [REDPHARM DRUG INC.] 2 CEFPROZIL ANHYDROUS ACTIVE MOIETY 1M698F4H4E CEFPROZIL TABLET [REDPHARM DRUG INC.] 2 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U CEFPROZIL TABLET [REDPHARM DRUG INC.] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 CEFPROZIL TABLET [REDPHARM DRUG INC.] 2 METHYLCELLULOSE (15 CPS) INACTIVE INGREDIENT NPU9M2E6L8 CEFPROZIL TABLET [REDPHARM DRUG INC.] 2 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 CEFPROZIL TABLET [REDPHARM DRUG INC.] 2 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP CEFPROZIL TABLET [REDPHARM DRUG INC.] 2 CEFPROZIL ACTIVE INGREDIENT 4W0459ZA4V CEFPROZIL TABLET [PHYSICIANS TOTAL CARE, INC.] 1 CEFPROZIL ANHYDROUS ACTIVE MOIETY 1M698F4H4E CEFPROZIL TABLET [PHYSICIANS TOTAL CARE, INC.] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U CEFPROZIL TABLET [PHYSICIANS TOTAL CARE, INC.] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 CEFPROZIL TABLET [PHYSICIANS TOTAL CARE, INC.] 1 METHYLCELLULOSE (15 CPS) INACTIVE INGREDIENT NPU9M2E6L8 CEFPROZIL TABLET [PHYSICIANS TOTAL CARE, INC.] 1 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 CEFPROZIL TABLET [PHYSICIANS TOTAL CARE, INC.] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP CEFPROZIL TABLET [PHYSICIANS TOTAL CARE, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68180-404 CEFPROZIL TABLET [LUPIN PHARMACEUTICALS, INC.] 9 Current NDC, Legacy NDC, 1 package rows 20250130_14527f4a-ce99-449d-a5a5-9edd7fb28dee.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 · 1 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 68180-404-01 68180040401 50 TABLET in 1 BOTTLE (68180-404-01) 50 tablet 2005-12-01 0000-00-00 No No Current 68180-404-02 68180040402 100 TABLET in 1 BOTTLE (68180-404-02) 100 tablet 2005-12-01 0000-00-00 No No Current