Home NDC 63304-963 Cefuroxime Axetil For Oral Suspension
Product NDC 63304-963
11-digit product format 633040963
Labeler code 63304
Product ID 63304-963_037e5290-f39e-45ef-a05c-51b0ce2c4473
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Cefuroxime Axetil
Dosage form SUSPENSION
Route ORAL
Labeler Ranbaxy Pharmaceuticals Inc
Application ANDA065323
Marketing category ANDA
Marketing start 2008-02-08
Marketing end 0000-00-00
Substance CEFUROXIME AXETIL
Active strength 125 mg/5mL
Pharmacologic classes Cephalosporin Antibacterial [EPC],Cephalosporins [CS]
NDC exclude flag E
Listing certified through 2017-12-31
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 2 · 66 matching rows.
View current auxiliary records. · View the auxiliary file history.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
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 A065323-001 CEFUROXIME AXETIL CEFUROXIME AXETIL EQ 125MG BASE/5ML FOR SUSPENSION / ORAL 2008-02-05 A065323-002 CEFUROXIME AXETIL CEFUROXIME AXETIL EQ 250MG BASE/5ML FOR SUSPENSION / ORAL 2008-02-05
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 · 88 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 2026-10-15 13:18:30 2026-09 A065323-001 CEFUROXIME AXETIL EQ 125MG BASE/5ML FOR SUSPENSION / ORAL 2008-02-05 c2088c7a36db…2026-10-15 13:18:30 2026-09 A065323-002 CEFUROXIME AXETIL EQ 250MG BASE/5ML FOR SUSPENSION / ORAL 2008-02-05 c2088c7a36db…2026-09-14 22:38:34 2026-08 A065323-001 CEFUROXIME AXETIL EQ 125MG BASE/5ML FOR SUSPENSION / ORAL 2008-02-05 84e616aacf4f…2026-09-14 22:38:34 2026-08 A065323-002 CEFUROXIME AXETIL EQ 250MG BASE/5ML FOR SUSPENSION / ORAL 2008-02-05 84e616aacf4f…2026-08-18 06:07:40 2026-07 A065323-001 CEFUROXIME AXETIL EQ 125MG BASE/5ML FOR SUSPENSION / ORAL 2008-02-05 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A065323-002 CEFUROXIME AXETIL EQ 250MG BASE/5ML FOR SUSPENSION / ORAL 2008-02-05 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A065323-001 CEFUROXIME AXETIL EQ 125MG BASE/5ML FOR SUSPENSION / ORAL 2008-02-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A065323-002 CEFUROXIME AXETIL EQ 250MG BASE/5ML FOR SUSPENSION / ORAL 2008-02-05 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065323-001 CEFUROXIME AXETIL EQ 125MG BASE/5ML FOR SUSPENSION / ORAL 2008-02-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065323-002 CEFUROXIME AXETIL EQ 250MG BASE/5ML FOR SUSPENSION / ORAL 2008-02-05 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A065323-001 CEFUROXIME AXETIL EQ 125MG BASE/5ML FOR SUSPENSION / ORAL 2008-02-05 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A065323-002 CEFUROXIME AXETIL EQ 250MG BASE/5ML FOR SUSPENSION / ORAL 2008-02-05 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065323-001 CEFUROXIME AXETIL EQ 125MG BASE/5ML FOR SUSPENSION / ORAL 2008-02-05 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065323-002 CEFUROXIME AXETIL EQ 250MG BASE/5ML FOR SUSPENSION / ORAL 2008-02-05 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065323-001 CEFUROXIME AXETIL EQ 125MG BASE/5ML FOR SUSPENSION / ORAL 2008-02-05 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065323-002 CEFUROXIME AXETIL EQ 250MG BASE/5ML FOR SUSPENSION / ORAL 2008-02-05 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065323-001 CEFUROXIME AXETIL EQ 125MG BASE/5ML FOR SUSPENSION / ORAL 2008-02-05 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065323-002 CEFUROXIME AXETIL EQ 250MG BASE/5ML FOR SUSPENSION / ORAL 2008-02-05 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065323-001 CEFUROXIME AXETIL EQ 125MG BASE/5ML FOR SUSPENSION / ORAL 2008-02-05 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065323-002 CEFUROXIME AXETIL EQ 250MG BASE/5ML FOR SUSPENSION / ORAL 2008-02-05 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065323-001 CEFUROXIME AXETIL EQ 125MG BASE/5ML FOR SUSPENSION / ORAL 2008-02-05 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065323-002 CEFUROXIME AXETIL EQ 250MG BASE/5ML FOR SUSPENSION / ORAL 2008-02-05 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065323-001 CEFUROXIME AXETIL EQ 125MG BASE/5ML FOR SUSPENSION / ORAL 2008-02-05 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065323-002 CEFUROXIME AXETIL EQ 250MG BASE/5ML FOR SUSPENSION / ORAL 2008-02-05 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A065323-001 CEFUROXIME AXETIL EQ 125MG BASE/5ML FOR SUSPENSION / ORAL 2008-02-05 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A065323-002 CEFUROXIME AXETIL EQ 250MG BASE/5ML FOR SUSPENSION / ORAL 2008-02-05 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065323-001 CEFUROXIME AXETIL EQ 125MG BASE/5ML FOR SUSPENSION / ORAL 2008-02-05 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065323-002 CEFUROXIME AXETIL EQ 250MG BASE/5ML FOR SUSPENSION / ORAL 2008-02-05 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065323-001 CEFUROXIME AXETIL EQ 125MG BASE/5ML FOR SUSPENSION / ORAL 2008-02-05 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065323-002 CEFUROXIME AXETIL EQ 250MG BASE/5ML FOR SUSPENSION / ORAL 2008-02-05 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A065323-001 CEFUROXIME AXETIL EQ 125MG BASE/5ML FOR SUSPENSION / ORAL 2008-02-05 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A065323-002 CEFUROXIME AXETIL EQ 250MG BASE/5ML FOR SUSPENSION / ORAL 2008-02-05 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A065323-001 CEFUROXIME AXETIL EQ 125MG BASE/5ML FOR SUSPENSION / ORAL 2008-02-05 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A065323-002 CEFUROXIME AXETIL EQ 250MG BASE/5ML FOR SUSPENSION / ORAL 2008-02-05 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A065323-001 CEFUROXIME AXETIL EQ 125MG BASE/5ML FOR SUSPENSION / ORAL 2008-02-05 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A065323-002 CEFUROXIME AXETIL EQ 250MG BASE/5ML FOR SUSPENSION / ORAL 2008-02-05 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A065323-001 CEFUROXIME AXETIL EQ 125MG BASE/5ML FOR SUSPENSION / ORAL 2008-02-05 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A065323-002 CEFUROXIME AXETIL EQ 250MG BASE/5ML FOR SUSPENSION / ORAL 2008-02-05 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A065323-001 CEFUROXIME AXETIL EQ 125MG BASE/5ML FOR SUSPENSION / ORAL 2008-02-05 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A065323-002 CEFUROXIME AXETIL EQ 250MG BASE/5ML FOR SUSPENSION / ORAL 2008-02-05 4b0b4de00fa7…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 63304-963-03 Cefuroxime Axetil For Oral Suspension 50 mL in 1 BOTTLE SUSPENSION 50 1 63304-963-04 Cefuroxime Axetil For Oral Suspension 100 mL in 1 BOTTLE SUSPENSION 100 1
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63304-963 CEFUROXIME AXETIL FOR ORAL SUSPENSION (CEFUROXIME AXETIL) SUSPENSION [RANBAXY PHARMACEUTICALS INC] 1 Legacy NDC, 2 package rows 20130821_135e2dfc-eb47-4d04-a903-a081d36c267e.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Status 63304-963-03 63304096303 50 mL in 1 BOTTLE 50 ml Historical 63304-963-04 63304096304 100 mL in 1 BOTTLE 100 ml Historical