Home NDC 54643-9015-2 Adult Infuvite Multiple Vitamins
Product NDC 54643-9015
Requested package NDC 54643-9015-2
11-digit product format 546439015
Labeler code 54643
Product ID 54643-9015_10174266-1bd1-44a5-a1be-41d0be88d949
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Ascorbic Acid, Vitamin A Palmitate, Cholecalciferol, Thiamine Hydrochloride, Riboflavin-5 phosphate sodium, Pyridoxine Hydrochloride, Niacinamide, Dexpanthenol, Alpha-tocopherol acetate, Vitamin K1, Folic Acid, Biotin, Cyanocobalamin
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Sandoz Inc
Application NDA021559
Marketing category NDA
Marketing start 2003-06-16
Marketing end 0000-00-00
Substance .ALPHA.-TOCOPHEROL ACETATE; ASCORBIC ACID; BIOTIN; CHOLECALCIFEROL; CYANOCOBALAMIN; DEXPANTHENOL; FOLIC ACID; NIACINAMIDE; PHYTONADIONE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN 5'-PHOSPHATE SODIUM; THIAMINE HYDROCHLORIDE; VITAMIN A PALMITATE
Active strength 10 [iU]/10mL; mg/10mL; ug/10mL; [iU]/10mL; ug/10mL; mg/10mL; ug/10mL; mg/10mL; ug/10mL; mg/10mL; mg/10mL; mg/10mL; [iU]/10mL
Pharmacologic classes Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Increased Prothrombin Activity [PE], Reversed Anticoagulation Activity [PE], Vitamin A [CS], Vitamin A [EPC], Vitamin B 12 [CS], Vitamin B 6 [Chemical/Ingredient], Vitamin B12 [EPC], Vitamin B6 Analog [EPC], Vitamin C [EPC], Vitamin D [CS], Vitamin D [EPC], Vitamin K [CS], Vitamin K [EPC], Warfarin Reversal Agent [EPC]
NDC exclude flag No
Listing certified through 2023-12-31
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 1 · 2 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 54643-9015 54643-9015-2 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 54643-9015 54643-9015-2 D Discontinued by firm excluded / ndc_excluded.zip f5e01cc5f278…a2eaf40c39c3…
Source provenance: Browse the complete Orange Book source catalog .
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.
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 2019-09-15 20:21 UTC 2019-09 N021559-001 INFUVITE ADULT 2 IU/ML;40MG/ML;12MCG/ML;40 IU/ML;1MCG/ML;3MG/ML;120MCG/ML;8MG/ML;1.2MG/ML;0.72MG/ML;1.2MG/ML;660 IU/ML;30MCG/ML SOLUTION / INTRAVENOUS RLD, RS 2003-06-16 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N021559-001 INFUVITE ADULT 2 IU/ML;40MG/ML;12MCG/ML;40 IU/ML;1MCG/ML;3MG/ML;120MCG/ML;8MG/ML;1.2MG/ML;0.72MG/ML;1.2MG/ML;660 IU/ML;30MCG/ML SOLUTION / INTRAVENOUS RLD, RS 2003-06-16 ea99ee380514…
DailyMed Product Concepts# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 54643-9015-2 54643901502 2 VIAL in 1 CARTON (54643-9015-2) > 50 mL in 1 VIAL 2 vial 2016-12-23 0000-00-00 No No Current