Home NDC 0781-5439 Cefpodoxime Proxetil
Product NDC 0781-5439
11-digit product format 007815439
Labeler code 0781
Product ID 0781-5439_6878b572-5711-43a8-9972-1410927f1f14
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Cefpodoxime Proxetil
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Sandoz Inc
Application ANDA065462
Marketing category ANDA
Marketing start 2008-05-28
Substance CEFPODOXIME PROXETIL
Active strength 200 mg/1
Pharmacologic classes Cephalosporin Antibacterial [EPC], Cephalosporins [CS]
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 A065462-001 CEFPODOXIME PROXETIL CEFPODOXIME PROXETIL EQ 100MG BASE TABLET / ORAL AB 2008-05-28 A065462-002 CEFPODOXIME PROXETIL CEFPODOXIME PROXETIL EQ 200MG BASE TABLET / ORAL AB RS 2008-05-28
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 A065462-001 CEFPODOXIME PROXETIL EQ 100MG BASE TABLET / ORAL AB 2008-05-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A065462-002 CEFPODOXIME PROXETIL EQ 200MG BASE TABLET / ORAL AB RS 2008-05-28 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A065462-001 CEFPODOXIME PROXETIL EQ 100MG BASE TABLET / ORAL AB 2008-05-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A065462-002 CEFPODOXIME PROXETIL EQ 200MG BASE TABLET / ORAL AB RS 2008-05-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065462-001 CEFPODOXIME PROXETIL EQ 100MG BASE TABLET / ORAL AB 2008-05-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065462-002 CEFPODOXIME PROXETIL EQ 200MG BASE TABLET / ORAL AB RS 2008-05-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A065462-001 CEFPODOXIME PROXETIL EQ 100MG BASE TABLET / ORAL AB 2008-05-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A065462-002 CEFPODOXIME PROXETIL EQ 200MG BASE TABLET / ORAL AB RS 2008-05-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065462-001 CEFPODOXIME PROXETIL EQ 100MG BASE TABLET / ORAL AB 2008-05-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065462-002 CEFPODOXIME PROXETIL EQ 200MG BASE TABLET / ORAL AB RS 2008-05-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065462-001 CEFPODOXIME PROXETIL EQ 100MG BASE TABLET / ORAL AB 2008-05-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065462-002 CEFPODOXIME PROXETIL EQ 200MG BASE TABLET / ORAL AB RS 2008-05-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065462-001 CEFPODOXIME PROXETIL EQ 100MG BASE TABLET / ORAL AB 2008-05-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065462-002 CEFPODOXIME PROXETIL EQ 200MG BASE TABLET / ORAL AB RS 2008-05-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065462-001 CEFPODOXIME PROXETIL EQ 100MG BASE TABLET / ORAL AB 2008-05-28 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065462-002 CEFPODOXIME PROXETIL EQ 200MG BASE TABLET / ORAL AB RS 2008-05-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065462-001 CEFPODOXIME PROXETIL EQ 100MG BASE TABLET / ORAL AB 2008-05-28 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065462-002 CEFPODOXIME PROXETIL EQ 200MG BASE TABLET / ORAL AB RS 2008-05-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065462-001 CEFPODOXIME PROXETIL EQ 100MG BASE TABLET / ORAL AB 2008-05-28 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065462-002 CEFPODOXIME PROXETIL EQ 200MG BASE TABLET / ORAL AB RS 2008-05-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A065462-001 CEFPODOXIME PROXETIL EQ 100MG BASE TABLET / ORAL AB 2008-05-28 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A065462-002 CEFPODOXIME PROXETIL EQ 200MG BASE TABLET / ORAL AB RS 2008-05-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065462-001 CEFPODOXIME PROXETIL EQ 100MG BASE TABLET / ORAL AB 2008-05-28 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065462-002 CEFPODOXIME PROXETIL EQ 200MG BASE TABLET / ORAL AB RS 2008-05-28 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065462-001 CEFPODOXIME PROXETIL EQ 100MG BASE TABLET / ORAL AB 2008-05-28 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065462-002 CEFPODOXIME PROXETIL EQ 200MG BASE TABLET / ORAL AB RS 2008-05-28 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A065462-001 CEFPODOXIME PROXETIL EQ 100MG BASE TABLET / ORAL AB 2008-05-28 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A065462-002 CEFPODOXIME PROXETIL EQ 200MG BASE TABLET / ORAL AB RS 2008-05-28 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A065462-001 CEFPODOXIME PROXETIL EQ 100MG BASE TABLET / ORAL AB 2008-05-28 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A065462-002 CEFPODOXIME PROXETIL EQ 200MG BASE TABLET / ORAL AB RS 2008-05-28 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A065462-001 CEFPODOXIME PROXETIL EQ 100MG BASE TABLET / ORAL AB 2008-05-28 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A065462-002 CEFPODOXIME PROXETIL EQ 200MG BASE TABLET / ORAL AB RS 2008-05-28 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A065462-001 CEFPODOXIME PROXETIL EQ 100MG BASE TABLET / ORAL AB 2008-05-28 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A065462-002 CEFPODOXIME PROXETIL EQ 200MG BASE TABLET / ORAL AB RS 2008-05-28 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A065462-001 CEFPODOXIME PROXETIL EQ 100MG BASE TABLET / ORAL AB 2008-05-28 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A065462-002 CEFPODOXIME PROXETIL EQ 200MG BASE TABLET / ORAL AB RS 2008-05-28 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A065462-001 CEFPODOXIME PROXETIL EQ 100MG BASE TABLET / ORAL AB 2008-05-28 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A065462-002 CEFPODOXIME PROXETIL EQ 200MG BASE TABLET / ORAL AB RS 2008-05-28 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A065462-001 CEFPODOXIME PROXETIL EQ 100MG BASE TABLET / ORAL AB 2008-05-28 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A065462-002 CEFPODOXIME PROXETIL EQ 200MG BASE TABLET / ORAL AB RS 2008-05-28 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 Cefpodoxime Proxetil
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CEFPODOXIME PROXETIL 200 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2TB00A1Z7N Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 309076 Internal RxNorm lookup 309078 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 0781-5439-01 Cefpodoxime Proxetil 100 in 1 BOTTLE TABLET, FILM COATED 100 17 0781-5439-20 Cefpodoxime Proxetil 20 in 1 BOTTLE TABLET, FILM COATED 20 17
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded CEFPODOXIME PROXETIL ACTIVE INGREDIENT 2TB00A1Z7N CEFPODOXIME PROXETIL TABLET, FILM COATED [SANDOZ INC] 14 CEFPODOXIME ACTIVE MOIETY 7R4F94TVGY CEFPODOXIME PROXETIL TABLET, FILM COATED [SANDOZ INC] 14 CARBOXYMETHYLCELLULOSE CALCIUM INACTIVE INGREDIENT UTY7PDF93L CEFPODOXIME PROXETIL TABLET, FILM COATED [SANDOZ INC] 14 CROSPOVIDONE INACTIVE INGREDIENT 68401960MK CEFPODOXIME PROXETIL TABLET, FILM COATED [SANDOZ INC] 14 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 CEFPODOXIME PROXETIL TABLET, FILM COATED [SANDOZ INC] 14 HYDROXYPROPYL CELLULOSE (TYPE H) INACTIVE INGREDIENT RFW2ET671P CEFPODOXIME PROXETIL TABLET, FILM COATED [SANDOZ INC] 14 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO CEFPODOXIME PROXETIL TABLET, FILM COATED [SANDOZ INC] 14 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X CEFPODOXIME PROXETIL TABLET, FILM COATED [SANDOZ INC] 14 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 CEFPODOXIME PROXETIL TABLET, FILM COATED [SANDOZ INC] 14 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J CEFPODOXIME PROXETIL TABLET, FILM COATED [SANDOZ INC] 14 TALC INACTIVE INGREDIENT 7SEV7J4R1U CEFPODOXIME PROXETIL TABLET, FILM COATED [SANDOZ INC] 14 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP CEFPODOXIME PROXETIL TABLET, FILM COATED [SANDOZ INC] 14
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0781-5439 CEFPODOXIME PROXETIL TABLET, FILM COATED [SANDOZ INC] 17 Current NDC, Legacy NDC, 2 package rows 20210402_8519a9d8-7106-4545-bc58-859ee9a6708e.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 Marketing start Marketing end Sample Exclude flag Status 0781-5439-01 00781543901 100 TABLET, FILM COATED in 1 BOTTLE (0781-5439-01) 2008-05-28 0000-00-00 No No Current 0781-5439-20 00781543920 20 TABLET, FILM COATED in 1 BOTTLE (0781-5439-20) 2008-05-28 0000-00-00 No No Current