Home NDC 69043-007 CEFPODOXIME PROXETIL
Product NDC 69043-007
11-digit product format 690430007
Labeler code 69043
Product ID 69043-007_36f0759f-b50b-4a49-869b-d73f5ad7d8cf
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name CEFPODOXIME PROXETIL
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Cronus Pharma LLC
Application ANDA065370
Marketing category ANDA
Marketing start 2007-06-11
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 A065370-001 CEFPODOXIME PROXETIL CEFPODOXIME PROXETIL EQ 100MG BASE TABLET / ORAL AB 2007-06-11 A065370-002 CEFPODOXIME PROXETIL CEFPODOXIME PROXETIL EQ 200MG BASE TABLET / ORAL AB 2007-06-11
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 A065370-001 CEFPODOXIME PROXETIL EQ 100MG BASE TABLET / ORAL AB 2007-06-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A065370-002 CEFPODOXIME PROXETIL EQ 200MG BASE TABLET / ORAL AB 2007-06-11 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A065370-001 CEFPODOXIME PROXETIL EQ 100MG BASE TABLET / ORAL AB 2007-06-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A065370-002 CEFPODOXIME PROXETIL EQ 200MG BASE TABLET / ORAL AB 2007-06-11 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065370-001 CEFPODOXIME PROXETIL EQ 100MG BASE TABLET / ORAL AB 2007-06-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065370-002 CEFPODOXIME PROXETIL EQ 200MG BASE TABLET / ORAL AB 2007-06-11 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A065370-001 CEFPODOXIME PROXETIL EQ 100MG BASE TABLET / ORAL AB 2007-06-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A065370-002 CEFPODOXIME PROXETIL EQ 200MG BASE TABLET / ORAL AB 2007-06-11 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065370-001 CEFPODOXIME PROXETIL EQ 100MG BASE TABLET / ORAL AB 2007-06-11 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065370-002 CEFPODOXIME PROXETIL EQ 200MG BASE TABLET / ORAL AB 2007-06-11 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065370-001 CEFPODOXIME PROXETIL EQ 100MG BASE TABLET / ORAL AB 2007-06-11 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065370-002 CEFPODOXIME PROXETIL EQ 200MG BASE TABLET / ORAL AB 2007-06-11 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065370-001 CEFPODOXIME PROXETIL EQ 100MG BASE TABLET / ORAL AB 2007-06-11 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065370-002 CEFPODOXIME PROXETIL EQ 200MG BASE TABLET / ORAL AB 2007-06-11 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065370-001 CEFPODOXIME PROXETIL EQ 100MG BASE TABLET / ORAL AB 2007-06-11 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065370-002 CEFPODOXIME PROXETIL EQ 200MG BASE TABLET / ORAL AB 2007-06-11 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065370-001 CEFPODOXIME PROXETIL EQ 100MG BASE TABLET / ORAL AB 2007-06-11 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065370-002 CEFPODOXIME PROXETIL EQ 200MG BASE TABLET / ORAL AB 2007-06-11 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065370-001 CEFPODOXIME PROXETIL EQ 100MG BASE TABLET / ORAL AB 2007-06-11 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065370-002 CEFPODOXIME PROXETIL EQ 200MG BASE TABLET / ORAL AB 2007-06-11 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A065370-001 CEFPODOXIME PROXETIL EQ 100MG BASE TABLET / ORAL AB 2007-06-11 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A065370-002 CEFPODOXIME PROXETIL EQ 200MG BASE TABLET / ORAL AB 2007-06-11 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065370-001 CEFPODOXIME PROXETIL EQ 100MG BASE TABLET / ORAL AB 2007-06-11 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065370-002 CEFPODOXIME PROXETIL EQ 200MG BASE TABLET / ORAL AB 2007-06-11 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065370-001 CEFPODOXIME PROXETIL EQ 100MG BASE TABLET / ORAL AB 2007-06-11 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065370-002 CEFPODOXIME PROXETIL EQ 200MG BASE TABLET / ORAL AB 2007-06-11 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A065370-001 CEFPODOXIME PROXETIL EQ 100MG BASE TABLET / ORAL AB 2007-06-11 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A065370-002 CEFPODOXIME PROXETIL EQ 200MG BASE TABLET / ORAL AB 2007-06-11 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A065370-001 CEFPODOXIME PROXETIL EQ 100MG BASE TABLET / ORAL AB 2007-06-11 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A065370-002 CEFPODOXIME PROXETIL EQ 200MG BASE TABLET / ORAL AB 2007-06-11 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A065370-001 CEFPODOXIME PROXETIL EQ 100MG BASE TABLET / ORAL AB 2007-06-11 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A065370-002 CEFPODOXIME PROXETIL EQ 200MG BASE TABLET / ORAL AB 2007-06-11 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A065370-001 CEFPODOXIME PROXETIL EQ 100MG BASE TABLET / ORAL AB 2007-06-11 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A065370-002 CEFPODOXIME PROXETIL EQ 200MG BASE TABLET / ORAL AB 2007-06-11 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A065370-001 CEFPODOXIME PROXETIL EQ 100MG BASE TABLET / ORAL AB 2007-06-11 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A065370-002 CEFPODOXIME PROXETIL EQ 200MG BASE TABLET / ORAL AB 2007-06-11 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A065370-001 CEFPODOXIME PROXETIL EQ 100MG BASE TABLET / ORAL AB 2007-06-11 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A065370-002 CEFPODOXIME PROXETIL EQ 200MG BASE TABLET / ORAL AB 2007-06-11 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A065370-001 CEFPODOXIME PROXETIL EQ 100MG BASE TABLET / ORAL AB 2007-06-11 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A065370-002 CEFPODOXIME PROXETIL EQ 200MG BASE TABLET / ORAL AB 2007-06-11 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 2026-12-31 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 69043-007-01 CEFPODOXIME PROXETIL 100 in 1 BOTTLE TABLET, FILM COATED 100 6 69043-007-25 CEFPODOXIME PROXETIL 250 in 1 BOTTLE TABLET, FILM COATED 250 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69043-007 CEFPODOXIME PROXETIL TABLET, FILM COATED [CRONUS PHARMA LLC] 6 Current NDC, Legacy NDC, 2 package rows 20240106_bc9c338c-1fc7-4bc2-a357-a78e433cbe9d.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 · 3 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 69043-007-01 69043000701 100 TABLET, FILM COATED in 1 BOTTLE (69043-007-01) 2007-06-11 0000-00-00 No No Current 69043-007-25 69043000725 250 TABLET, FILM COATED in 1 BOTTLE (69043-007-25) 2023-10-06 No No Current