Home NDC 54643-9031 Pediatric Infuvite Multiple Vitamins
Product NDC 54643-9031
11-digit product format 546439031
Labeler code 54643
Product ID 54643-9031_4a121d03-e32c-4a67-8641-fc0fc7aafe13
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 KIT
Labeler Sandoz Inc
Application NDA021646
Marketing category NDA
Marketing start 2016-12-23
Marketing end 0000-00-00
Active strength 0
NDC exclude flag No
Listing certified through 2023-12-31
Current FDA listing Historical FDA.report record 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 N021646-001 INFUVITE PEDIATRIC (PHARMACY BULK PACKAGE) 80MG/VIAL;0.02MG/VIAL;400 IU/VIAL;0.001MG/VIAL;5MG/VIAL;0.14MG/VIAL;17MG/VIAL;1MG/VIAL;1.4MG/VIAL;1.2MG/VIAL;7 IU/VIAL;2,300 IU/VIAL;0.2MG/VIAL INJECTABLE / IV (INFUSION) RLD, RS 2004-01-29 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N021646-001 INFUVITE PEDIATRIC (PHARMACY BULK PACKAGE) 80MG/VIAL;0.02MG/VIAL;400 IU/VIAL;0.001MG/VIAL;5MG/VIAL;0.14MG/VIAL;17MG/VIAL;1MG/VIAL;1.4MG/VIAL;1.2MG/VIAL;7 IU/VIAL;2,300 IU/VIAL;0.2MG/VIAL INJECTABLE / INTRAVENOUS RLD, RS 2004-01-29 ea99ee380514…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Pediatric Infuvite Multiple Vitamins Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 13 matching rows.
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1305217 Internal RxNorm lookup 1305222 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 54643-9031-0 Pediatric Infuvite Multiple Vitamins 1 in 1 CARTON KIT 1 7
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 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Pediatric Infuvite Multiple Vitamins 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 Sandoz Inc 4ff223f7-e076-4e81-8151-5c06724fabd9 2025-08-18 Warnings, Adverse reactions Exact identifier application applno (NDA): 021646 application number: NDA021646 ndc (product): 54643-9031
DailyMed RxNorm Mappings# RxCUI, RxNorm string, TTY table RxCUI RxNorm string TTY DailyMed SPL version 1305222 Infuvite Pediatric 1.4 UNT/mL / 16 MG/mL / 0.004 MG/mL / 80 UNT/mL / 1 MG/mL / 0.028 MG/mL / 3.4 MG/mL / 0.2 MG/mL / 460 UNT/mL / 0.28 MG/mL / 0.24 MG/mL / 0.0002 MG/mL / 0.04 MG/mL Injectable Solution PSN 4ff223f7-e076-4e81-8151-5c06724fabd9 7 1305222 alpha-tocopherol acetate 1.4 UNT/ML / ascorbic acid 16 MG/ML / biotin 0.004 MG/ML / cholecalciferol 80 UNT/ML / dexpanthenol 1 MG/ML / folic acid 0.028 MG/ML / niacinamide 3.4 MG/ML / pyridoxine hydrochloride 0.2 MG/ML / riboflavin 0.28 MG/ML / thiamine hydrochloride 0.24 MG/ML / vitamin A palmitate 460 UNT/ML / vitamin B12 0.0002 MG/ML / vitamin K1 0.04 MG/ML Injectable Solution [Infuvite Pediatric] SBD 4ff223f7-e076-4e81-8151-5c06724fabd9 7 1305217 alpha-tocopherol acetate 1.4 UNT/ML / ascorbic acid 16 MG/ML / biotin 0.004 MG/ML / cholecalciferol 80 UNT/ML / dexpanthenol 1 MG/ML / folic acid 0.028 MG/ML / niacinamide 3.4 MG/ML / pyridoxine hydrochloride 0.2 MG/ML / riboflavin 0.28 MG/ML / thiamine hydrochloride 0.24 MG/ML / vitamin A palmitate 460 UNT/ML / vitamin B12 0.0002 MG/ML / vitamin K1 0.04 MG/ML Injectable Solution SCD 4ff223f7-e076-4e81-8151-5c06724fabd9 7 1305217 alpha-tocopherol acetate 1.4 UNT/ML / vit-C 16 MG/ML / biotin 0.004 MG/ML / cholecalciferol 80 UNT/ML / dexpanthenol 1 MG/ML / folate 0.028 MG/ML / niacinamide 3.4 MG/ML / vit-B6 hydrochloride 0.2 MG/ML / riboflavin 0.28 MG/ML / vit-B1 hydrochloride 0.24 MG/ML / vitamin A palmitate 460 UNT/ML / vitamin B12 0.0002 MG/ML / vitamin K1 0.04 MG/ML Injectable Solution SY 4ff223f7-e076-4e81-8151-5c06724fabd9 7 1305222 alpha-tocopherol acetate 1.4 UNT/ML / vit-C 16 MG/ML / biotin 0.004 MG/ML / cholecalciferol 80 UNT/ML / dexpanthenol 1 MG/ML / folate 0.028 MG/ML / niacinamide 3.4 MG/ML / vit-B6 hydrochloride 0.2 MG/ML / riboflavin 0.28 MG/ML / vit-B1 hydrochloride 0.24 MG/ML / vitamin A palmitate 460 UNT/ML / vitamin B12 0.0002 MG/ML / vitamin K1 0.04 MG/ML Injectable Solution [Infuvite Pediatric] SY 4ff223f7-e076-4e81-8151-5c06724fabd9 7 1305217 alpha-tocopherol acetate 1.4 UNT/ML / vit-C 16 MG/ML / biotin 0.004 MG/ML / cholecalciferol 80 UNT/ML / dexpanthenol 1 MG/ML / folate 0.028 MG/ML / niacinamide 3.4 MG/ML / vit-B6 hydrochloride 0.2 MG/ML / riboflavin 0.28 MG/ML / vitamin B1 hydrochloride 0.24 MG/ML / vitamin A palmitate 460 UNT/ML / vitamin B12 0.0002 MG/ML / vitamin K1 0.04 MG/ML Injectable Solution SY 4ff223f7-e076-4e81-8151-5c06724fabd9 7 1305222 alpha-tocopherol acetate 1.4 UNT/ML / vit-C 16 MG/ML / biotin 0.004 MG/ML / cholecalciferol 80 UNT/ML / dexpanthenol 1 MG/ML / folate 0.028 MG/ML / niacinamide 3.4 MG/ML / vit-B6 hydrochloride 0.2 MG/ML / riboflavin 0.28 MG/ML / vitamin B1 hydrochloride 0.24 MG/ML / vitamin A palmitate 460 UNT/ML / vitamin B12 0.0002 MG/ML / vitamin K1 0.04 MG/ML Injectable Solution [Infuvite Pediatric] SY 4ff223f7-e076-4e81-8151-5c06724fabd9 7 1305217 alpha-tocopherol acetate 1.4 UNT/ML / vit-C 16 MG/ML / biotin 0.004 MG/ML / cholecalciferol 80 UNT/ML / dexpanthenol 1 MG/ML / folate 0.028 MG/ML / niacinamide 3.4 MG/ML / vitamin B6 hydrochloride 0.2 MG/ML / riboflavin 0.28 MG/ML / vit-B1 hydrochloride 0.24 MG/ML / vitamin A palmitate 460 UNT/ML / vitamin B12 0.0002 MG/ML / vitamin K1 0.04 MG/ML Injectable Solution SY 4ff223f7-e076-4e81-8151-5c06724fabd9 7 1305222 alpha-tocopherol acetate 1.4 UNT/ML / vit-C 16 MG/ML / biotin 0.004 MG/ML / cholecalciferol 80 UNT/ML / dexpanthenol 1 MG/ML / folate 0.028 MG/ML / niacinamide 3.4 MG/ML / vitamin B6 hydrochloride 0.2 MG/ML / riboflavin 0.28 MG/ML / vit-B1 hydrochloride 0.24 MG/ML / vitamin A palmitate 460 UNT/ML / vitamin B12 0.0002 MG/ML / vitamin K1 0.04 MG/ML Injectable Solution [Infuvite Pediatric] SY 4ff223f7-e076-4e81-8151-5c06724fabd9 7 1305217 alpha-tocopherol acetate 1.4 UNT/ML / vit-C 16 MG/ML / biotin 0.004 MG/ML / cholecalciferol 80 UNT/ML / dexpanthenol 1 MG/ML / folate 0.028 MG/ML / niacinamide 3.4 MG/ML / vitamin B6 hydrochloride 0.2 MG/ML / riboflavin 0.28 MG/ML / vitamin B1 hydrochloride 0.24 MG/ML / vitamin A palmitate 460 UNT/ML / vitamin B12 0.0002 MG/ML / vitamin K1 0.04 MG/ML Injectable Solution SY 4ff223f7-e076-4e81-8151-5c06724fabd9 7 1305222 alpha-tocopherol acetate 1.4 UNT/ML / vit-C 16 MG/ML / biotin 0.004 MG/ML / cholecalciferol 80 UNT/ML / dexpanthenol 1 MG/ML / folate 0.028 MG/ML / niacinamide 3.4 MG/ML / vitamin B6 hydrochloride 0.2 MG/ML / riboflavin 0.28 MG/ML / vitamin B1 hydrochloride 0.24 MG/ML / vitamin A palmitate 460 UNT/ML / vitamin B12 0.0002 MG/ML / vitamin K1 0.04 MG/ML Injectable Solution [Infuvite Pediatric] SY 4ff223f7-e076-4e81-8151-5c06724fabd9 7 1305217 alpha-tocopherol acetate 1.4 UNT/ML / vitamin C 16 MG/ML / biotin 0.004 MG/ML / cholecalciferol 80 UNT/ML / dexpanthenol 1 MG/ML / folate 0.028 MG/ML / niacinamide 3.4 MG/ML / vit-B6 hydrochloride 0.2 MG/ML / riboflavin 0.28 MG/ML / vit-B1 hydrochloride 0.24 MG/ML / vitamin A palmitate 460 UNT/ML / vitamin B12 0.0002 MG/ML / vitamin K1 0.04 MG/ML Injectable Solution SY 4ff223f7-e076-4e81-8151-5c06724fabd9 7 1305222 alpha-tocopherol acetate 1.4 UNT/ML / vitamin C 16 MG/ML / biotin 0.004 MG/ML / cholecalciferol 80 UNT/ML / dexpanthenol 1 MG/ML / folate 0.028 MG/ML / niacinamide 3.4 MG/ML / vit-B6 hydrochloride 0.2 MG/ML / riboflavin 0.28 MG/ML / vit-B1 hydrochloride 0.24 MG/ML / vitamin A palmitate 460 UNT/ML / vitamin B12 0.0002 MG/ML / vitamin K1 0.04 MG/ML Injectable Solution [Infuvite Pediatric] SY 4ff223f7-e076-4e81-8151-5c06724fabd9 7 1305217 alpha-tocopherol acetate 1.4 UNT/ML / vitamin C 16 MG/ML / biotin 0.004 MG/ML / cholecalciferol 80 UNT/ML / dexpanthenol 1 MG/ML / folate 0.028 MG/ML / niacinamide 3.4 MG/ML / vit-B6 hydrochloride 0.2 MG/ML / riboflavin 0.28 MG/ML / vitamin B1 hydrochloride 0.24 MG/ML / vitamin A palmitate 460 UNT/ML / vitamin B12 0.0002 MG/ML / vitamin K1 0.04 MG/ML Injectable Solution SY 4ff223f7-e076-4e81-8151-5c06724fabd9 7 1305222 alpha-tocopherol acetate 1.4 UNT/ML / vitamin C 16 MG/ML / biotin 0.004 MG/ML / cholecalciferol 80 UNT/ML / dexpanthenol 1 MG/ML / folate 0.028 MG/ML / niacinamide 3.4 MG/ML / vit-B6 hydrochloride 0.2 MG/ML / riboflavin 0.28 MG/ML / vitamin B1 hydrochloride 0.24 MG/ML / vitamin A palmitate 460 UNT/ML / vitamin B12 0.0002 MG/ML / vitamin K1 0.04 MG/ML Injectable Solution [Infuvite Pediatric] SY 4ff223f7-e076-4e81-8151-5c06724fabd9 7 1305217 alpha-tocopherol acetate 1.4 UNT/ML / vitamin C 16 MG/ML / biotin 0.004 MG/ML / cholecalciferol 80 UNT/ML / dexpanthenol 1 MG/ML / folate 0.028 MG/ML / niacinamide 3.4 MG/ML / vitamin B6 hydrochloride 0.2 MG/ML / riboflavin 0.28 MG/ML / vit-B1 hydrochloride 0.24 MG/ML / vitamin A palmitate 460 UNT/ML / vitamin B12 0.0002 MG/ML / vitamin K1 0.04 MG/ML Injectable Solution SY 4ff223f7-e076-4e81-8151-5c06724fabd9 7 1305222 alpha-tocopherol acetate 1.4 UNT/ML / vitamin C 16 MG/ML / biotin 0.004 MG/ML / cholecalciferol 80 UNT/ML / dexpanthenol 1 MG/ML / folate 0.028 MG/ML / niacinamide 3.4 MG/ML / vitamin B6 hydrochloride 0.2 MG/ML / riboflavin 0.28 MG/ML / vit-B1 hydrochloride 0.24 MG/ML / vitamin A palmitate 460 UNT/ML / vitamin B12 0.0002 MG/ML / vitamin K1 0.04 MG/ML Injectable Solution [Infuvite Pediatric] SY 4ff223f7-e076-4e81-8151-5c06724fabd9 7 1305217 alpha-tocopherol acetate 1.4 UNT/ML / vitamin C 16 MG/ML / biotin 0.004 MG/ML / cholecalciferol 80 UNT/ML / dexpanthenol 1 MG/ML / folate 0.028 MG/ML / niacinamide 3.4 MG/ML / vitamin B6 hydrochloride 0.2 MG/ML / riboflavin 0.28 MG/ML / vitamin B1 hydrochloride 0.24 MG/ML / vitamin A palmitate 460 UNT/ML / vitamin B12 0.0002 MG/ML / vitamin K1 0.04 MG/ML Injectable Solution SY 4ff223f7-e076-4e81-8151-5c06724fabd9 7 1305222 alpha-tocopherol acetate 1.4 UNT/ML / vitamin C 16 MG/ML / biotin 0.004 MG/ML / cholecalciferol 80 UNT/ML / dexpanthenol 1 MG/ML / folate 0.028 MG/ML / niacinamide 3.4 MG/ML / vitamin B6 hydrochloride 0.2 MG/ML / riboflavin 0.28 MG/ML / vitamin B1 hydrochloride 0.24 MG/ML / vitamin A palmitate 460 UNT/ML / vitamin B12 0.0002 MG/ML / vitamin K1 0.04 MG/ML Injectable Solution [Infuvite Pediatric] SY 4ff223f7-e076-4e81-8151-5c06724fabd9 7 1305222 Infuvite Pediatric (alpha-tocopherol acetate 7 UNT / ascorbic acid 80 MG / biotin 20 MCG / cholecalciferol 400 UNT / cyanocobalmin 1 MCG / dexpanthenol 5 MG / folic acid 140 MCG / niacinamide 17 MG / phytonadione 0.2 MG / pyridoxine hydrochloride 1 MG / riboflavin 1.4 MG / thiamine hydrochloride 1.2 MG / vitamin A palmitate 2300 UNT) per 5 ML Injectable Solution SY 4ff223f7-e076-4e81-8151-5c06724fabd9 7 1305222 Infuvite Pediatric Injectable Solution SY 4ff223f7-e076-4e81-8151-5c06724fabd9 7
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 54643-9031-0 54643903100 1 KIT in 1 CARTON (54643-9031-0) * 40 mL in 1 VIAL * 10 mL in 1 VIAL 1 kit 2016-12-23 0000-00-00 No No Current