Home NDC 64980-403 Cefpodoxime Proxetil
Product NDC 64980-403
11-digit product format 649800403
Labeler code 64980
Product ID 64980-403_803b37ff-46c6-4dcb-9d9f-a118c4c4601b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Cefpodoxime Proxetil
Dosage form GRANULE, FOR SUSPENSION
Route ORAL
Labeler Rising Pharma Holdings, Inc.
Application ANDA065409
Marketing category ANDA
Marketing start 2007-06-08
Substance CEFPODOXIME PROXETIL
Active strength 100 mg/5mL
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 A065409-001 CEFPODOXIME PROXETIL CEFPODOXIME PROXETIL EQ 50MG BASE/5ML FOR SUSPENSION / ORAL 2007-06-08 A065409-002 CEFPODOXIME PROXETIL CEFPODOXIME PROXETIL EQ 100MG BASE/5ML FOR SUSPENSION / ORAL RS 2007-06-08
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 A065409-001 CEFPODOXIME PROXETIL EQ 50MG BASE/5ML FOR SUSPENSION / ORAL 2007-06-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A065409-002 CEFPODOXIME PROXETIL EQ 100MG BASE/5ML FOR SUSPENSION / ORAL RS 2007-06-08 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A065409-001 CEFPODOXIME PROXETIL EQ 50MG BASE/5ML FOR SUSPENSION / ORAL 2007-06-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A065409-002 CEFPODOXIME PROXETIL EQ 100MG BASE/5ML FOR SUSPENSION / ORAL RS 2007-06-08 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065409-001 CEFPODOXIME PROXETIL EQ 50MG BASE/5ML FOR SUSPENSION / ORAL 2007-06-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065409-002 CEFPODOXIME PROXETIL EQ 100MG BASE/5ML FOR SUSPENSION / ORAL RS 2007-06-08 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A065409-001 CEFPODOXIME PROXETIL EQ 50MG BASE/5ML FOR SUSPENSION / ORAL 2007-06-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A065409-002 CEFPODOXIME PROXETIL EQ 100MG BASE/5ML FOR SUSPENSION / ORAL RS 2007-06-08 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065409-001 CEFPODOXIME PROXETIL EQ 50MG BASE/5ML FOR SUSPENSION / ORAL 2007-06-08 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065409-002 CEFPODOXIME PROXETIL EQ 100MG BASE/5ML FOR SUSPENSION / ORAL RS 2007-06-08 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065409-001 CEFPODOXIME PROXETIL EQ 50MG BASE/5ML FOR SUSPENSION / ORAL 2007-06-08 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065409-002 CEFPODOXIME PROXETIL EQ 100MG BASE/5ML FOR SUSPENSION / ORAL RS 2007-06-08 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065409-001 CEFPODOXIME PROXETIL EQ 50MG BASE/5ML FOR SUSPENSION / ORAL 2007-06-08 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065409-002 CEFPODOXIME PROXETIL EQ 100MG BASE/5ML FOR SUSPENSION / ORAL RS 2007-06-08 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065409-001 CEFPODOXIME PROXETIL EQ 50MG BASE/5ML FOR SUSPENSION / ORAL 2007-06-08 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065409-002 CEFPODOXIME PROXETIL EQ 100MG BASE/5ML FOR SUSPENSION / ORAL RS 2007-06-08 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065409-001 CEFPODOXIME PROXETIL EQ 50MG BASE/5ML FOR SUSPENSION / ORAL 2007-06-08 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065409-002 CEFPODOXIME PROXETIL EQ 100MG BASE/5ML FOR SUSPENSION / ORAL RS 2007-06-08 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065409-001 CEFPODOXIME PROXETIL EQ 50MG BASE/5ML FOR SUSPENSION / ORAL 2007-06-08 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065409-002 CEFPODOXIME PROXETIL EQ 100MG BASE/5ML FOR SUSPENSION / ORAL RS 2007-06-08 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A065409-001 CEFPODOXIME PROXETIL EQ 50MG BASE/5ML FOR SUSPENSION / ORAL 2007-06-08 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A065409-002 CEFPODOXIME PROXETIL EQ 100MG BASE/5ML FOR SUSPENSION / ORAL RS 2007-06-08 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065409-001 CEFPODOXIME PROXETIL EQ 50MG BASE/5ML FOR SUSPENSION / ORAL 2007-06-08 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065409-002 CEFPODOXIME PROXETIL EQ 100MG BASE/5ML FOR SUSPENSION / ORAL RS 2007-06-08 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065409-001 CEFPODOXIME PROXETIL EQ 50MG BASE/5ML FOR SUSPENSION / ORAL 2007-06-08 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065409-002 CEFPODOXIME PROXETIL EQ 100MG BASE/5ML FOR SUSPENSION / ORAL RS 2007-06-08 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A065409-001 CEFPODOXIME PROXETIL EQ 50MG BASE/5ML FOR SUSPENSION / ORAL 2007-06-08 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A065409-002 CEFPODOXIME PROXETIL EQ 100MG BASE/5ML FOR SUSPENSION / ORAL RS 2007-06-08 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A065409-001 CEFPODOXIME PROXETIL EQ 50MG BASE/5ML FOR SUSPENSION / ORAL 2007-06-08 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A065409-002 CEFPODOXIME PROXETIL EQ 100MG BASE/5ML FOR SUSPENSION / ORAL RS 2007-06-08 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A065409-001 CEFPODOXIME PROXETIL EQ 50MG BASE/5ML FOR SUSPENSION / ORAL 2007-06-08 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A065409-002 CEFPODOXIME PROXETIL EQ 100MG BASE/5ML FOR SUSPENSION / ORAL RS 2007-06-08 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A065409-001 CEFPODOXIME PROXETIL EQ 50MG BASE/5ML FOR SUSPENSION / ORAL 2007-06-08 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A065409-002 CEFPODOXIME PROXETIL EQ 100MG BASE/5ML FOR SUSPENSION / ORAL RS 2007-06-08 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A065409-001 CEFPODOXIME PROXETIL EQ 50MG BASE/5ML FOR SUSPENSION / ORAL 2007-06-08 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A065409-002 CEFPODOXIME PROXETIL EQ 100MG BASE/5ML FOR SUSPENSION / ORAL RS 2007-06-08 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A065409-001 CEFPODOXIME PROXETIL EQ 50MG BASE/5ML FOR SUSPENSION / ORAL 2007-06-08 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A065409-002 CEFPODOXIME PROXETIL EQ 100MG BASE/5ML FOR SUSPENSION / ORAL RS 2007-06-08 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A065409-001 CEFPODOXIME PROXETIL EQ 50MG BASE/5ML FOR SUSPENSION / ORAL 2007-06-08 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A065409-002 CEFPODOXIME PROXETIL EQ 100MG BASE/5ML FOR SUSPENSION / ORAL RS 2007-06-08 bb7c543d1eb4…
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 100 mg/5mL
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 309077 Internal RxNorm lookup 309079 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 64980-403-10 Cefpodoxime Proxetil 100 mL in 1 BOTTLE GRANULE, FOR SUSPENSION 100 7 64980-403-10 Cefpodoxime Proxetil 1 in 1 CARTON GRANULE, FOR SUSPENSION 1 7 64980-403-50 Cefpodoxime Proxetil 1 in 1 CARTON GRANULE, FOR SUSPENSION 1 7 64980-403-50 Cefpodoxime Proxetil 50 mL in 1 BOTTLE GRANULE, FOR SUSPENSION 50 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 64980-403 CEFPODOXIME PROXETIL GRANULE, FOR SUSPENSION [RISING PHARMA HOLDINGS, INC.] 6 Current NDC, Legacy NDC, 4 package rows 20240105_edf589b2-f796-4522-a5e6-2bd0a833922f.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 Units Marketing start Marketing end Sample Exclude flag Status 64980-403-10 64980040310 1 BOTTLE in 1 CARTON (64980-403-10) / 100 mL in 1 BOTTLE 1 bottle 2007-06-08 0000-00-00 No No Current 64980-403-50 64980040350 1 BOTTLE in 1 CARTON (64980-403-50) / 50 mL in 1 BOTTLE 1 bottle 2007-06-08 0000-00-00 No No Current