Home NDC 65862-068 Cefprozil
Product NDC 65862-068
11-digit product format 658620068
Labeler code 65862
Product ID 65862-068_6397ff45-3c37-40c3-a924-d036bb896b3b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Cefprozil
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Aurobindo Pharma Limited
Application ANDA065340
Marketing category ANDA
Marketing start 2007-05-24
Substance CEFPROZIL
Active strength 250 mg/1
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes NDC auxiliary status# These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
Current NDC status page 1 of 1 · 2 matching rows.
Dataset, Scope, Product NDC table Dataset Scope Product NDC Package NDC Code Status Reporting period Source date unfinished product product 65862-068 UNFINISHED Active or certified unfinished drug listing 2026-08-17 unfinished package package 65862-068 65862-068-39 UNFINISHED Active or certified unfinished drug listing 2026-08-17
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 · 42 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 21:27 UTC · source 2025-12-05 unfinished product product a6255e0c9aa5…a0211a219f2e…2025-12-14 21:27 UTC · source 2025-12-05 unfinished package package 65862-068-39 a6255e0c9aa5…a0211a219f2e…2025-08-26 23:59 UTC · source 2025-08-26 unfinished product product 1d862106b807…00c93037cd84…2025-08-26 23:59 UTC · source 2025-08-26 unfinished package package 65862-068-39 1d862106b807…00c93037cd84…2025-05-15 14:59 UTC · source 2025-05-14 unfinished product product 390b4c401c3f…2c692c2daee3…2025-05-15 14:59 UTC · source 2025-05-14 unfinished package package 65862-068-39 390b4c401c3f…2c692c2daee3…2025-04-01 07:37 UTC · source 2025-03-31 unfinished product product e30019b0c005…a3f0b14938b7…2025-04-01 07:37 UTC · source 2025-03-31 unfinished package package 65862-068-39 e30019b0c005…a3f0b14938b7…2025-03-01 13:19 UTC · source 2025-02-28 unfinished product product bbbc9f937eca…946b9c97cf81…2025-03-01 13:19 UTC · source 2025-02-28 unfinished package package 65862-068-39 bbbc9f937eca…946b9c97cf81…2025-02-27 05:24 UTC · source 2025-02-26 unfinished product product f268b84574a6…26285f5ac5df…2025-02-27 05:24 UTC · source 2025-02-26 unfinished package package 65862-068-39 f268b84574a6…26285f5ac5df…2025-02-01 13:13 UTC · source 2025-01-31 unfinished product product f764e8902f78…92046438deef…2025-02-01 13:13 UTC · source 2025-01-31 unfinished package package 65862-068-39 f764e8902f78…92046438deef…2025-01-20 13:05 UTC · source 2025-01-17 unfinished product product 68b1e3bced9e…98a755eb8bc6…2025-01-20 13:05 UTC · source 2025-01-17 unfinished package package 65862-068-39 68b1e3bced9e…98a755eb8bc6…2024-11-29 20:42 UTC · source 2024-11-29 unfinished product product 05c55d027831…ca05dca9dc4c…2024-11-29 20:42 UTC · source 2024-11-29 unfinished package package 65862-068-39 05c55d027831…ca05dca9dc4c…2024-11-09 02:36 UTC · source 2024-11-08 unfinished product product 48b4f40e6753…c7c7a00d2afa…2024-11-09 02:36 UTC · source 2024-11-08 unfinished package package 65862-068-39 48b4f40e6753…c7c7a00d2afa…2024-10-09 02:27 UTC · source 2024-10-08 unfinished product product 27f29a85d7e4…1372111e901f…2024-10-09 02:27 UTC · source 2024-10-08 unfinished package package 65862-068-39 27f29a85d7e4…1372111e901f…2024-07-10 04:00 UTC · source 2024-07-09 unfinished product product 8d62ce987f31…9fe9ef23e30d…2024-07-10 04:00 UTC · source 2024-07-09 unfinished package package 65862-068-39 8d62ce987f31…9fe9ef23e30d…2024-05-28 21:11 UTC · source 2024-05-28 unfinished product product d1e113ab4d42…063ee3eb0a1d…2024-05-28 21:11 UTC · source 2024-05-28 unfinished package package 65862-068-39 d1e113ab4d42…063ee3eb0a1d…2024-05-15 03:51 UTC · source 2024-05-14 unfinished product product 50b4072663b7…eae3003ed65e…2024-05-15 03:51 UTC · source 2024-05-14 unfinished package package 65862-068-39 50b4072663b7…eae3003ed65e…2022-04-09 23:13 UTC · source 2022-04-08 unfinished product product 906f6e251498…bf70b80e44f0…2022-04-09 23:13 UTC · source 2022-04-08 unfinished package package 65862-068-39 906f6e251498…bf70b80e44f0…2021-12-27 23:28 UTC · source 2021-12-27 unfinished product product 6db9cb8d1e19…3449e1ec5b70…2021-12-27 23:28 UTC · source 2021-12-27 unfinished package package 65862-068-39 6db9cb8d1e19…3449e1ec5b70…2021-02-18 23:40 UTC · source 2021-02-18 unfinished product product 8fc7167e32ce…e96bbc724034…2021-02-18 23:40 UTC · source 2021-02-18 unfinished package package 65862-068-39 8fc7167e32ce…e96bbc724034…2020-12-18 03:04 UTC · source 2020-12-17 unfinished product product 4184dd79f89f…545327b3e20f…2020-12-18 03:04 UTC · source 2020-12-17 unfinished package package 65862-068-39 4184dd79f89f…545327b3e20f…2020-06-10 20:45 UTC · source 2020-06-10 unfinished product product 4bd3596a7b87…5c64c6f6865f…2020-06-10 20:45 UTC · source 2020-06-10 unfinished package package 65862-068-39 4bd3596a7b87…5c64c6f6865f…2019-12-08 06:16 UTC · source 2019-12-05 unfinished product product 263afe128892…91768de4ddbe…2019-12-08 06:16 UTC · source 2019-12-05 unfinished package package 65862-068-39 263afe128892…91768de4ddbe…2019-06-01 22:24 UTC · source 2019-05-30 unfinished product product 5b2001dcd8f5…54b53d4dc9e4…2019-06-01 22:24 UTC · source 2019-05-30 unfinished package package 65862-068-39 5b2001dcd8f5…54b53d4dc9e4…
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 A065340-001 CEFPROZIL CEFPROZIL 250MG TABLET / ORAL AB 2007-05-24 A065340-002 CEFPROZIL CEFPROZIL 500MG TABLET / ORAL AB 2007-05-24
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 A065340-001 CEFPROZIL 250MG TABLET / ORAL AB 2007-05-24 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A065340-002 CEFPROZIL 500MG TABLET / ORAL AB 2007-05-24 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A065340-001 CEFPROZIL 250MG TABLET / ORAL AB 2007-05-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A065340-002 CEFPROZIL 500MG TABLET / ORAL AB 2007-05-24 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065340-001 CEFPROZIL 250MG TABLET / ORAL AB 2007-05-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065340-002 CEFPROZIL 500MG TABLET / ORAL AB 2007-05-24 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A065340-001 CEFPROZIL 250MG TABLET / ORAL AB 2007-05-24 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A065340-002 CEFPROZIL 500MG TABLET / ORAL AB 2007-05-24 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065340-001 CEFPROZIL 250MG TABLET / ORAL AB 2007-05-24 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065340-002 CEFPROZIL 500MG TABLET / ORAL AB 2007-05-24 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065340-001 CEFPROZIL 250MG TABLET / ORAL AB 2007-05-24 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065340-002 CEFPROZIL 500MG TABLET / ORAL AB 2007-05-24 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065340-001 CEFPROZIL 250MG TABLET / ORAL AB 2007-05-24 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065340-002 CEFPROZIL 500MG TABLET / ORAL AB 2007-05-24 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065340-001 CEFPROZIL 250MG TABLET / ORAL AB 2007-05-24 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065340-002 CEFPROZIL 500MG TABLET / ORAL AB 2007-05-24 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065340-001 CEFPROZIL 250MG TABLET / ORAL AB 2007-05-24 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065340-002 CEFPROZIL 500MG TABLET / ORAL AB 2007-05-24 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065340-001 CEFPROZIL 250MG TABLET / ORAL AB 2007-05-24 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065340-002 CEFPROZIL 500MG TABLET / ORAL AB 2007-05-24 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A065340-001 CEFPROZIL 250MG TABLET / ORAL AB 2007-05-24 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A065340-002 CEFPROZIL 500MG TABLET / ORAL AB 2007-05-24 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065340-001 CEFPROZIL 250MG TABLET / ORAL AB 2007-05-24 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065340-002 CEFPROZIL 500MG TABLET / ORAL AB 2007-05-24 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065340-001 CEFPROZIL 250MG TABLET / ORAL AB 2007-05-24 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065340-002 CEFPROZIL 500MG TABLET / ORAL AB 2007-05-24 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A065340-001 CEFPROZIL 250MG TABLET / ORAL AB 2007-05-24 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A065340-002 CEFPROZIL 500MG TABLET / ORAL AB 2007-05-24 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A065340-001 CEFPROZIL 250MG TABLET / ORAL AB 2007-05-24 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A065340-002 CEFPROZIL 500MG TABLET / ORAL AB 2007-05-24 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A065340-001 CEFPROZIL 250MG TABLET / ORAL AB 2007-05-24 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A065340-002 CEFPROZIL 500MG TABLET / ORAL AB 2007-05-24 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A065340-001 CEFPROZIL 250MG TABLET / ORAL AB 2007-05-24 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A065340-002 CEFPROZIL 500MG TABLET / ORAL AB 2007-05-24 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A065340-001 CEFPROZIL 250MG TABLET / ORAL AB 2007-05-24 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A065340-002 CEFPROZIL 500MG TABLET / ORAL AB 2007-05-24 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A065340-001 CEFPROZIL 250MG TABLET / ORAL AB 2007-05-24 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A065340-002 CEFPROZIL 500MG TABLET / ORAL AB 2007-05-24 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A065340-001 CEFPROZIL 250MG TABLET / ORAL AB 2007-05-24 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A065340-002 CEFPROZIL 500MG TABLET / ORAL AB 2007-05-24 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/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 65862-068-01 Cefprozil 100 in 1 BOTTLE TABLET, FILM COATED 100 11 65862-068-05 Cefprozil 500 in 1 BOTTLE TABLET, FILM COATED 500 11 65862-068-30 Cefprozil 30 in 1 BOTTLE TABLET, FILM COATED 30 11 65862-068-50 Cefprozil 50 in 1 BOTTLE TABLET, FILM COATED 50 11
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded CEFPROZIL ACTIVE INGREDIENT 4W0459ZA4V CEFPROZIL TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] 5 CEFPROZIL ANHYDROUS ACTIVE MOIETY 1M698F4H4E CEFPROZIL TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] 5 AMMONIA INACTIVE INGREDIENT 5138Q19F1X CEFPROZIL TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] 5 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U CEFPROZIL TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] 5 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 CEFPROZIL TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] 5 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 CEFPROZIL TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] 5 HYPROMELLOSE 2910 (3 MPA.S) INACTIVE INGREDIENT 0VUT3PMY82 CEFPROZIL TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] 5 HYPROMELLOSE 2910 (5 MPA.S) INACTIVE INGREDIENT R75537T0T4 CEFPROZIL TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] 5 HYPROMELLOSE 2910 (6 MPA.S) INACTIVE INGREDIENT 0WZ8WG20P6 CEFPROZIL TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] 5 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 CEFPROZIL TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] 5 POLYETHYLENE GLYCOL 400 INACTIVE INGREDIENT B697894SGQ CEFPROZIL TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] 5 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H CEFPROZIL TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] 5 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 CEFPROZIL TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] 5 SHELLAC INACTIVE INGREDIENT 46N107B71O CEFPROZIL TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] 5 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 CEFPROZIL TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] 5 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP CEFPROZIL TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 65862-068 CEFPROZIL TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] 11 Current NDC, Legacy NDC, 4 package rows 20240507_b9111a81-07c4-4458-b994-a4ad504986d8.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 Marketing start Marketing end Sample Exclude flag Status 65862-068-01 65862006801 100 TABLET, FILM COATED in 1 BOTTLE (65862-068-01) 2007-05-24 0000-00-00 No No Current 65862-068-05 65862006805 500 TABLET, FILM COATED in 1 BOTTLE (65862-068-05) 2007-05-24 0000-00-00 No No Current 65862-068-30 65862006830 30 TABLET, FILM COATED in 1 BOTTLE (65862-068-30) 2007-05-24 0000-00-00 No No Current 65862-068-39 65862006839 3000 TABLET, FILM COATED in 1 BAG (65862-068-39) 24-MAY-07 Current 65862-068-50 65862006850 50 TABLET, FILM COATED in 1 BOTTLE (65862-068-50) 2007-05-24 0000-00-00 No No Current