FDA.reportPublic FDA data

Pediatric Infuvite Multiple Vitamins

Product NDC
54643-9031
Requested package NDC
54643-9031-0
11-digit product format
546439031
Labeler code
54643
Product ID
54643-9031_447b597f-d7fe-4489-b755-9929b40032f4
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
2026-10-31
NDC exclude flag
No
Current FDA listing
Yes

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2019-09-15 20:21 UTC2019-09N021646-001INFUVITE 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/VIALINJECTABLE / IV (INFUSION)RLD, RS2004-01-29b00525d2431f…
2019-07-19 19:46 UTC2019-07N021646-001INFUVITE 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/VIALINJECTABLE / INTRAVENOUSRLD, RS2004-01-29ea99ee380514…

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.

Identifier, FDA.report destination table
IdentifierFDA.report destination
PQ6CK8PD0RInternal UNII lookup
1D1K0N0VVCInternal UNII lookup
1C6V77QF41Internal UNII lookup
M572600E5PInternal UNII lookup
20RD1DZH99Internal UNII lookup
68Y4CF58BVInternal UNII lookup
25X51I8RD4Internal UNII lookup
1O6C93RI7ZInternal UNII lookup
9E8X80D2L0Internal UNII lookup
A034SE7857Internal UNII lookup
935E97BOY8Internal UNII lookup
6SO6U10H04Internal UNII lookup
P6YC3EG204Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1305217Internal RxNorm lookup
1305222Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4ff223f7-e076-4e81-8151-5c06724fabd9Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
16a2c1cd-ae95-d910-f03d-7e06b11dd243Product name520260202
653485de-0601-41e4-82db-7a60bb223e27Product name120251024
cf050ccd-1144-f76a-e00d-e5698d8597d4Product name620250625
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
23fb3cda-2b50-f3d3-ebde-f542350bd77bProduct name420240828
b82b4008-22fd-05f5-6cc6-c0a6e81c65b8Product name220240805
081b54f0-4545-48b6-b854-03e1401f09eaProduct name120230112
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
91c62db0-0295-c81c-d10a-0856c259edd6Product name220200428
d32bc2b8-0bb7-2216-87aa-24639646e202Product name320190619
aead65a2-216e-4ff8-a178-44aab77c24edProduct name120180531
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122
d206bb34-ea65-399d-70d9-834f22dc2c18Product name320170724
5e18e798-5614-cf5c-0185-38b1cb77a093Product name220160822
60c52429-fcef-eb54-2387-43bc9e4f296bProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54643-9031-0Pediatric Infuvite Multiple Vitamins1 in 1 CARTONKIT17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
54643-9031-0ML - Milliliter54643-9031024cc817-3523-4b06-8971-2795463fedee12017-07-07

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Pediatric Infuvite Multiple VitaminsASCORBIC ACID, VITAMIN A PALMITATE, CHOLECALCIFEROL, THIAMINE HYDROCHLORIDE, RIBOFLAVIN-5 PHOSPHATE SODIUM, PYRIDOXINE HYDROCHLORIDE, NIACINAMIDE, DEXPANTHENOL, ALPHA-TOCOPHEROL ACETATE, VITAMIN K1, FOLIC ACID, BIOTIN, CYANOCOBALAMINSandoz Inc4ff223f7-e076-4e81-8151-5c06724fabd92025-08-18Warnings, Adverse reactionsExact identifier
application applno (NDA): 021646
application number: NDA021646
ndc (package): 54643-9031-0
ndc (product): 54643-9031
ndc11 (package): 54643903100

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1305222Infuvite 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 SolutionPSN4ff223f7-e076-4e81-8151-5c06724fabd97
1305222alpha-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]SBD4ff223f7-e076-4e81-8151-5c06724fabd97
1305217alpha-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 SolutionSCD4ff223f7-e076-4e81-8151-5c06724fabd97
1305217alpha-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 SolutionSY4ff223f7-e076-4e81-8151-5c06724fabd97
1305222alpha-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]SY4ff223f7-e076-4e81-8151-5c06724fabd97
1305217alpha-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 SolutionSY4ff223f7-e076-4e81-8151-5c06724fabd97
1305222alpha-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]SY4ff223f7-e076-4e81-8151-5c06724fabd97
1305217alpha-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 SolutionSY4ff223f7-e076-4e81-8151-5c06724fabd97
1305222alpha-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]SY4ff223f7-e076-4e81-8151-5c06724fabd97
1305217alpha-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 SolutionSY4ff223f7-e076-4e81-8151-5c06724fabd97
1305222alpha-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]SY4ff223f7-e076-4e81-8151-5c06724fabd97
1305217alpha-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 SolutionSY4ff223f7-e076-4e81-8151-5c06724fabd97
1305222alpha-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]SY4ff223f7-e076-4e81-8151-5c06724fabd97
1305217alpha-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 SolutionSY4ff223f7-e076-4e81-8151-5c06724fabd97
1305222alpha-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]SY4ff223f7-e076-4e81-8151-5c06724fabd97
1305217alpha-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 SolutionSY4ff223f7-e076-4e81-8151-5c06724fabd97
1305222alpha-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]SY4ff223f7-e076-4e81-8151-5c06724fabd97
1305217alpha-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 SolutionSY4ff223f7-e076-4e81-8151-5c06724fabd97
1305222alpha-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]SY4ff223f7-e076-4e81-8151-5c06724fabd97
1305222Infuvite 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 SolutionSY4ff223f7-e076-4e81-8151-5c06724fabd97
1305222Infuvite Pediatric Injectable SolutionSY4ff223f7-e076-4e81-8151-5c06724fabd97

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
54643-9031-0546439031001 KIT in 1 CARTON (54643-9031-0) * 40 mL in 1 VIAL * 10 mL in 1 VIAL1 kit2024-06-302026-10-31NoNoCurrent