CEFPROZIL

Product NDC
55648-712
11-digit product format
556480712
Labeler code
55648
Product ID
55648-712_ba6f00bd-79a2-46c1-87fa-054b258903ee
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CEFPROZIL
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Wockhardt Limited
Application
ANDA065428
Marketing category
ANDA
Marketing start
2007-06-15
Marketing end
0000-00-00
Substance
CEFPROZIL
Active strength
250 mg/1
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

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 · 5 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct55648-712IInactivated by FDA2026-08-17
excluded packagepackage55648-71255648-712-01IInactivated by FDA2026-08-17
excluded packagepackage55648-71255648-712-02IInactivated by FDA2026-08-17
excluded packagepackage55648-71255648-712-03IInactivated by FDA2026-08-17
excluded packagepackage55648-71255648-712-04IInactivated by FDA2026-08-17

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 2 · 110 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage55648-712-04d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage55648-712-01d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage55648-712-03d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage55648-712-02d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage55648-712-04f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage55648-712-01f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage55648-712-03f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage55648-712-02f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage55648-712-042ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage55648-712-012ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage55648-712-032ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage55648-712-022ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage55648-712-04a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage55648-712-01a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage55648-712-03a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage55648-712-02a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage55648-712-04cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage55648-712-01cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage55648-712-03cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage55648-712-02cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage55648-712-04cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage55648-712-01cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage55648-712-03cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage55648-712-02cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage55648-712-04302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage55648-712-01302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage55648-712-03302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage55648-712-02302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage55648-712-04ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage55648-712-01ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage55648-712-03ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage55648-712-02ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage55648-712-040efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage55648-712-010efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage55648-712-030efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage55648-712-020efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage55648-712-04ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage55648-712-01ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage55648-712-03ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage55648-712-02ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage55648-712-04367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage55648-712-01367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage55648-712-03367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage55648-712-02367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage55648-712-04557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage55648-712-01557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage55648-712-03557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage55648-712-02557ba5c1ecfa…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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A065428-001CEFPROZILCEFPROZIL250MGTABLET / ORAL2007-06-14
A065428-002CEFPROZILCEFPROZIL500MGTABLET / ORAL2007-06-14

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A065428-001CEFPROZIL250MGTABLET / ORAL2007-06-14caaa826d4ba7…
2026-08-18 06:07:402026-07A065428-002CEFPROZIL500MGTABLET / ORAL2007-06-14caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A065428-001CEFPROZIL250MGTABLET / ORAL2007-06-14011fe1cb6892…
2026-02-19 14:30 UTC2026-02A065428-002CEFPROZIL500MGTABLET / ORAL2007-06-14011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065428-001CEFPROZIL250MGTABLET / ORAL2007-06-1431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065428-002CEFPROZIL500MGTABLET / ORAL2007-06-1431067a03dcf5…
2025-08-23 18:47 UTC2025-08A065428-001CEFPROZIL250MGTABLET / ORAL2007-06-146a471c1ec25d…
2025-08-23 18:47 UTC2025-08A065428-002CEFPROZIL500MGTABLET / ORAL2007-06-146a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065428-001CEFPROZIL250MGTABLET / ORAL2007-06-14fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065428-002CEFPROZIL500MGTABLET / ORAL2007-06-14fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065428-001CEFPROZIL250MGTABLET / ORAL2007-06-14b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065428-002CEFPROZIL500MGTABLET / ORAL2007-06-14b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065428-001CEFPROZIL250MGTABLET / ORAL2007-06-1403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065428-002CEFPROZIL500MGTABLET / ORAL2007-06-1403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065428-001CEFPROZIL250MGTABLET / ORAL2007-06-142680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065428-002CEFPROZIL500MGTABLET / ORAL2007-06-142680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065428-001CEFPROZIL250MGTABLET / ORAL2007-06-145bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065428-002CEFPROZIL500MGTABLET / ORAL2007-06-145bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065428-001CEFPROZIL250MGTABLET / ORAL2007-06-14d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065428-002CEFPROZIL500MGTABLET / ORAL2007-06-14d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065428-001CEFPROZIL250MGTABLET / ORAL2007-06-14d06236e962d9…
2024-10-29 15:01 UTC2024-10A065428-002CEFPROZIL500MGTABLET / ORAL2007-06-14d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065428-001CEFPROZIL250MGTABLET / ORAL2007-06-1479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065428-002CEFPROZIL500MGTABLET / ORAL2007-06-1479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065428-001CEFPROZIL250MGTABLET / ORAL2007-06-14301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065428-002CEFPROZIL500MGTABLET / ORAL2007-06-14301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065428-001CEFPROZIL250MGTABLET / ORAL2007-06-141e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065428-002CEFPROZIL500MGTABLET / ORAL2007-06-141e350fbaab3a…
2024-05-31 18:47 UTC2024-05A065428-001CEFPROZIL250MGTABLET / ORAL2007-06-148072bd15b7f6…
2024-05-31 18:47 UTC2024-05A065428-002CEFPROZIL500MGTABLET / ORAL2007-06-148072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065428-001CEFPROZIL250MGTABLET / ORAL2007-06-145c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065428-002CEFPROZIL500MGTABLET / ORAL2007-06-145c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A065428-001CEFPROZIL250MGTABLET / ORAL2007-06-145d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A065428-002CEFPROZIL500MGTABLET / ORAL2007-06-145d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A065428-001CEFPROZIL250MGTABLET / ORAL2007-06-144b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A065428-002CEFPROZIL500MGTABLET / ORAL2007-06-144b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A065428-001CEFPROZIL250MGTABLET / ORALAB2007-06-1474a2ff9319b5…
2019-12-13 00:20 UTC2019-12A065428-002CEFPROZIL500MGTABLET / ORALAB2007-06-1474a2ff9319b5…
2022-03-09 01:35 UTC2022-03A065428-001CEFPROZIL250MGTABLET / ORAL2007-06-14bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A065428-002CEFPROZIL500MGTABLET / ORAL2007-06-14bb7c543d1eb4…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-12-13 00:20 UTC2019-12A065428-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A065428-002AB174a2ff9319b5…
2020-11-12 02:37 UTC2020-11A065428-001AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A065428-002AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A065428-001AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A065428-002AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A065428-001AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A065428-002AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A065428-001AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A065428-002AB1ea99ee380514…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
228ef569-e7f1-4dcf-b820-c09522f86f2eProduct name120250129

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55648-712-01CEFPROZIL50 in 1 BOTTLETABLET, FILM COATED501
55648-712-02CEFPROZIL1000 in 1 BOTTLETABLET, FILM COATED10001
55648-712-03CEFPROZIL100 in 1 BOTTLETABLET, FILM COATED1001
55648-712-04CEFPROZIL500 in 1 BOTTLETABLET, FILM COATED5001

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55648-712CEFPROZIL TABLET, FILM COATED CEFPROZIL TABLET, FILM COATED [WOCKHARDT LIMITED]1Legacy NDC, 4 package rows20120830_225011b9-0f3a-4afc-ac80-bd1f3739bb3b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197452cefprozil 250 MG Oral TabletPSN225011b9-0f3a-4afc-ac80-bd1f3739bb3b1
197453cefprozil 500 MG Oral TabletPSN225011b9-0f3a-4afc-ac80-bd1f3739bb3b1
197452cefprozil 250 MG Oral TabletSCD225011b9-0f3a-4afc-ac80-bd1f3739bb3b1
197453cefprozil 500 MG Oral TabletSCD225011b9-0f3a-4afc-ac80-bd1f3739bb3b1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
55648-712-015564807120150 in 1 BOTTLEHistorical
55648-712-02556480712021000 in 1 BOTTLEHistorical
55648-712-0355648071203100 in 1 BOTTLEHistorical
55648-712-0455648071204500 in 1 BOTTLEHistorical