Home NDC 0781-6168 Cefpodoxime Proxetil
Product NDC 0781-6168
11-digit product format 007816168
Labeler code 0781
Product ID 0781-6168_ca8fa9a5-094c-4c7e-8330-101ed5d68f6a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Cefpodoxime Proxetil
Dosage form GRANULE, FOR SUSPENSION
Route ORAL
Labeler Sandoz Inc
Application ANDA090031
Marketing category ANDA
Marketing start 2009-06-25
Marketing end 2019-07-31
Substance CEFPODOXIME PROXETIL
Active strength 50 mg/5mL
Pharmacologic classes Cephalosporin Antibacterial [EPC],Cephalosporins [CS]
NDC exclude flag No
Listing certified through 0000-00-00
Current FDA listing Historical FDA.report record 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 · 36 matching rows.
View current auxiliary records. · View the auxiliary file history.
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 A090031-001 CEFPODOXIME PROXETIL CEFPODOXIME PROXETIL EQ 50MG BASE/5ML FOR SUSPENSION / ORAL 2009-01-14 A090031-002 CEFPODOXIME PROXETIL CEFPODOXIME PROXETIL EQ 100MG BASE/5ML FOR SUSPENSION / ORAL 2009-01-14
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 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 A090031-001 CEFPODOXIME PROXETIL EQ 50MG BASE/5ML FOR SUSPENSION / ORAL 2009-01-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A090031-002 CEFPODOXIME PROXETIL EQ 100MG BASE/5ML FOR SUSPENSION / ORAL 2009-01-14 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A090031-001 CEFPODOXIME PROXETIL EQ 50MG BASE/5ML FOR SUSPENSION / ORAL 2009-01-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A090031-002 CEFPODOXIME PROXETIL EQ 100MG BASE/5ML FOR SUSPENSION / ORAL 2009-01-14 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090031-001 CEFPODOXIME PROXETIL EQ 50MG BASE/5ML FOR SUSPENSION / ORAL 2009-01-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090031-002 CEFPODOXIME PROXETIL EQ 100MG BASE/5ML FOR SUSPENSION / ORAL 2009-01-14 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A090031-001 CEFPODOXIME PROXETIL EQ 50MG BASE/5ML FOR SUSPENSION / ORAL 2009-01-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A090031-002 CEFPODOXIME PROXETIL EQ 100MG BASE/5ML FOR SUSPENSION / ORAL 2009-01-14 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090031-001 CEFPODOXIME PROXETIL EQ 50MG BASE/5ML FOR SUSPENSION / ORAL 2009-01-14 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090031-002 CEFPODOXIME PROXETIL EQ 100MG BASE/5ML FOR SUSPENSION / ORAL 2009-01-14 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090031-001 CEFPODOXIME PROXETIL EQ 50MG BASE/5ML FOR SUSPENSION / ORAL 2009-01-14 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090031-002 CEFPODOXIME PROXETIL EQ 100MG BASE/5ML FOR SUSPENSION / ORAL 2009-01-14 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090031-001 CEFPODOXIME PROXETIL EQ 50MG BASE/5ML FOR SUSPENSION / ORAL 2009-01-14 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090031-002 CEFPODOXIME PROXETIL EQ 100MG BASE/5ML FOR SUSPENSION / ORAL 2009-01-14 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090031-001 CEFPODOXIME PROXETIL EQ 50MG BASE/5ML FOR SUSPENSION / ORAL 2009-01-14 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090031-002 CEFPODOXIME PROXETIL EQ 100MG BASE/5ML FOR SUSPENSION / ORAL 2009-01-14 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090031-001 CEFPODOXIME PROXETIL EQ 50MG BASE/5ML FOR SUSPENSION / ORAL 2009-01-14 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090031-002 CEFPODOXIME PROXETIL EQ 100MG BASE/5ML FOR SUSPENSION / ORAL 2009-01-14 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090031-001 CEFPODOXIME PROXETIL EQ 50MG BASE/5ML FOR SUSPENSION / ORAL 2009-01-14 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090031-002 CEFPODOXIME PROXETIL EQ 100MG BASE/5ML FOR SUSPENSION / ORAL 2009-01-14 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A090031-001 CEFPODOXIME PROXETIL EQ 50MG BASE/5ML FOR SUSPENSION / ORAL 2009-01-14 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A090031-002 CEFPODOXIME PROXETIL EQ 100MG BASE/5ML FOR SUSPENSION / ORAL 2009-01-14 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090031-001 CEFPODOXIME PROXETIL EQ 50MG BASE/5ML FOR SUSPENSION / ORAL 2009-01-14 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090031-002 CEFPODOXIME PROXETIL EQ 100MG BASE/5ML FOR SUSPENSION / ORAL 2009-01-14 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A090031-001 CEFPODOXIME PROXETIL EQ 50MG BASE/5ML FOR SUSPENSION / ORAL 2009-01-14 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A090031-002 CEFPODOXIME PROXETIL EQ 100MG BASE/5ML FOR SUSPENSION / ORAL 2009-01-14 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A090031-001 CEFPODOXIME PROXETIL EQ 50MG BASE/5ML FOR SUSPENSION / ORAL 2009-01-14 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A090031-002 CEFPODOXIME PROXETIL EQ 100MG BASE/5ML FOR SUSPENSION / ORAL 2009-01-14 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A090031-001 CEFPODOXIME PROXETIL EQ 50MG BASE/5ML FOR SUSPENSION / ORAL 2009-01-14 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A090031-002 CEFPODOXIME PROXETIL EQ 100MG BASE/5ML FOR SUSPENSION / ORAL 2009-01-14 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A090031-001 CEFPODOXIME PROXETIL EQ 50MG BASE/5ML FOR SUSPENSION / ORAL 2009-01-14 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A090031-002 CEFPODOXIME PROXETIL EQ 100MG BASE/5ML FOR SUSPENSION / ORAL 2009-01-14 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A090031-001 CEFPODOXIME PROXETIL EQ 50MG BASE/5ML FOR SUSPENSION / ORAL 2009-01-14 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A090031-002 CEFPODOXIME PROXETIL EQ 100MG BASE/5ML FOR SUSPENSION / ORAL 2009-01-14 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A090031-001 CEFPODOXIME PROXETIL EQ 50MG BASE/5ML FOR SUSPENSION / ORAL 2009-01-14 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A090031-002 CEFPODOXIME PROXETIL EQ 100MG BASE/5ML FOR SUSPENSION / ORAL 2009-01-14 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A090031-001 CEFPODOXIME PROXETIL EQ 50MG BASE/5ML FOR SUSPENSION / ORAL 2009-01-14 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A090031-002 CEFPODOXIME PROXETIL EQ 100MG BASE/5ML FOR SUSPENSION / ORAL 2009-01-14 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A090031-001 CEFPODOXIME PROXETIL EQ 50MG BASE/5ML FOR SUSPENSION / ORAL 2009-01-14 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A090031-002 CEFPODOXIME PROXETIL EQ 100MG BASE/5ML FOR SUSPENSION / ORAL 2009-01-14 bb7c543d1eb4…