Cefpodoxime Proxetil

Product NDC
26637-712
11-digit product format
266370712
Labeler code
26637
Product ID
26637-712_85ac23fc-3642-4d37-af32-f0d36ab61882
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cefpodoxime Proxetil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Putney Inc
Application
ANDA065462
Marketing category
ANDA
Marketing start
2008-05-28
Marketing end
2020-12-31
Substance
CEFPODOXIME PROXETIL
Active strength
200 mg/1
Pharmacologic classes
Cephalosporin Antibacterial [EPC],Cephalosporins [CS]
NDC exclude flag
No
Listing certified through
0000-00-00
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct26637-712DDiscontinued by firm2026-08-17
excluded packagepackage26637-71226637-712-10DDiscontinued by firm2026-08-17

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 · 24 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 packagepackage26637-712-10d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage26637-712-10f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage26637-712-102ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage26637-712-10a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage26637-712-10cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage26637-712-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage26637-712-10302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage26637-712-10ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage26637-712-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage26637-712-10ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage26637-712-10367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage26637-712-10557ba5c1ecfa…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
A065462-001CEFPODOXIME PROXETILCEFPODOXIME PROXETILEQ 100MG BASETABLET / ORALAB2008-05-28
A065462-002CEFPODOXIME PROXETILCEFPODOXIME PROXETILEQ 200MG BASETABLET / ORALABRS2008-05-28

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A065462-001AB
A065462-002AB

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 06:07:402026-07A065462-001CEFPODOXIME PROXETILEQ 100MG BASETABLET / ORALAB2008-05-28caaa826d4ba7…
2026-08-18 06:07:402026-07A065462-002CEFPODOXIME PROXETILEQ 200MG BASETABLET / ORALABRS2008-05-28caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A065462-001CEFPODOXIME PROXETILEQ 100MG BASETABLET / ORALAB2008-05-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A065462-002CEFPODOXIME PROXETILEQ 200MG BASETABLET / ORALABRS2008-05-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065462-001CEFPODOXIME PROXETILEQ 100MG BASETABLET / ORALAB2008-05-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065462-002CEFPODOXIME PROXETILEQ 200MG BASETABLET / ORALABRS2008-05-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08A065462-001CEFPODOXIME PROXETILEQ 100MG BASETABLET / ORALAB2008-05-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A065462-002CEFPODOXIME PROXETILEQ 200MG BASETABLET / ORALABRS2008-05-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065462-001CEFPODOXIME PROXETILEQ 100MG BASETABLET / ORALAB2008-05-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065462-002CEFPODOXIME PROXETILEQ 200MG BASETABLET / ORALABRS2008-05-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065462-001CEFPODOXIME PROXETILEQ 100MG BASETABLET / ORALAB2008-05-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065462-002CEFPODOXIME PROXETILEQ 200MG BASETABLET / ORALABRS2008-05-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065462-001CEFPODOXIME PROXETILEQ 100MG BASETABLET / ORALAB2008-05-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065462-002CEFPODOXIME PROXETILEQ 200MG BASETABLET / ORALABRS2008-05-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065462-001CEFPODOXIME PROXETILEQ 100MG BASETABLET / ORALAB2008-05-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065462-002CEFPODOXIME PROXETILEQ 200MG BASETABLET / ORALABRS2008-05-282680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065462-001CEFPODOXIME PROXETILEQ 100MG BASETABLET / ORALAB2008-05-285bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065462-002CEFPODOXIME PROXETILEQ 200MG BASETABLET / ORALABRS2008-05-285bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065462-001CEFPODOXIME PROXETILEQ 100MG BASETABLET / ORALAB2008-05-28d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065462-002CEFPODOXIME PROXETILEQ 200MG BASETABLET / ORALABRS2008-05-28d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065462-001CEFPODOXIME PROXETILEQ 100MG BASETABLET / ORALAB2008-05-28d06236e962d9…
2024-10-29 15:01 UTC2024-10A065462-002CEFPODOXIME PROXETILEQ 200MG BASETABLET / ORALABRS2008-05-28d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065462-001CEFPODOXIME PROXETILEQ 100MG BASETABLET / ORALAB2008-05-2879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065462-002CEFPODOXIME PROXETILEQ 200MG BASETABLET / ORALABRS2008-05-2879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065462-001CEFPODOXIME PROXETILEQ 100MG BASETABLET / ORALAB2008-05-28301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065462-002CEFPODOXIME PROXETILEQ 200MG BASETABLET / ORALABRS2008-05-28301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065462-001CEFPODOXIME PROXETILEQ 100MG BASETABLET / ORALAB2008-05-281e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065462-002CEFPODOXIME PROXETILEQ 200MG BASETABLET / ORALABRS2008-05-281e350fbaab3a…
2024-05-31 18:47 UTC2024-05A065462-001CEFPODOXIME PROXETILEQ 100MG BASETABLET / ORALAB2008-05-288072bd15b7f6…
2024-05-31 18:47 UTC2024-05A065462-002CEFPODOXIME PROXETILEQ 200MG BASETABLET / ORALABRS2008-05-288072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065462-001CEFPODOXIME PROXETILEQ 100MG BASETABLET / ORALAB2008-05-285c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065462-002CEFPODOXIME PROXETILEQ 200MG BASETABLET / ORALABRS2008-05-285c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A065462-001CEFPODOXIME PROXETILEQ 100MG BASETABLET / ORALAB2008-05-285d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A065462-002CEFPODOXIME PROXETILEQ 200MG BASETABLET / ORALABRS2008-05-285d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A065462-001CEFPODOXIME PROXETILEQ 100MG BASETABLET / ORALAB2008-05-284b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A065462-002CEFPODOXIME PROXETILEQ 200MG BASETABLET / ORALABRS2008-05-284b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A065462-001CEFPODOXIME PROXETILEQ 100MG BASETABLET / ORALAB2008-05-2874a2ff9319b5…
2019-12-13 00:20 UTC2019-12A065462-002CEFPODOXIME PROXETILEQ 200MG BASETABLET / ORALABRS2008-05-2874a2ff9319b5…
2022-03-09 01:35 UTC2022-03A065462-001CEFPODOXIME PROXETILEQ 100MG BASETABLET / ORALAB2008-05-28bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A065462-002CEFPODOXIME PROXETILEQ 200MG BASETABLET / ORALABRS2008-05-28bb7c543d1eb4…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A065462-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A065462-002AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A065462-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A065462-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065462-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065462-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A065462-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A065462-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065462-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065462-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065462-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065462-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065462-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065462-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065462-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065462-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065462-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065462-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065462-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065462-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065462-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A065462-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065462-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065462-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065462-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065462-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065462-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065462-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A065462-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A065462-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065462-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065462-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A065462-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A065462-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A065462-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A065462-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A065462-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A065462-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A065462-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A065462-002AB1bb7c543d1eb4…

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CEFPODOXIME PROXETILACTIVE INGREDIENT2TB00A1Z7NCEFPODOXIME PROXETIL TABLET, FILM COATED [PUTNEY INC]12
CEFPODOXIMEACTIVE MOIETY7R4F94TVGYCEFPODOXIME PROXETIL TABLET, FILM COATED [PUTNEY INC]12
CARBOXYMETHYLCELLULOSE CALCIUMINACTIVE INGREDIENTUTY7PDF93LCEFPODOXIME PROXETIL TABLET, FILM COATED [PUTNEY INC]12
CROSPOVIDONEINACTIVE INGREDIENT68401960MKCEFPODOXIME PROXETIL TABLET, FILM COATED [PUTNEY INC]12
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8CEFPODOXIME PROXETIL TABLET, FILM COATED [PUTNEY INC]12
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PCEFPODOXIME PROXETIL TABLET, FILM COATED [PUTNEY INC]12
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOCEFPODOXIME PROXETIL TABLET, FILM COATED [PUTNEY INC]12
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCEFPODOXIME PROXETIL TABLET, FILM COATED [PUTNEY INC]12
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CEFPODOXIME PROXETIL TABLET, FILM COATED [PUTNEY INC]12
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JCEFPODOXIME PROXETIL TABLET, FILM COATED [PUTNEY INC]12
TALCINACTIVE INGREDIENT7SEV7J4R1UCEFPODOXIME PROXETIL TABLET, FILM COATED [PUTNEY INC]12
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCEFPODOXIME PROXETIL TABLET, FILM COATED [PUTNEY INC]12

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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cefpodoxime ProxetilCEFPODOXIME PROXETILSandoz Inc8519a9d8-7106-4545-bc58-859ee9a6708e2026-07-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065462
application number: ANDA065462