pediatric infuvite multiple vitamins

Generic: 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

Labeler: sandoz inc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name pediatric infuvite multiple vitamins
Generic 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
Labeler sandoz inc
Dosage Form KIT
Manufacturer
Sandoz Inc

Identifiers & Regulatory

Product NDC 54643-9031
Product ID 54643-9031_447b597f-d7fe-4489-b755-9929b40032f4
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA021646
Marketing Start 2016-12-23
Marketing End 2026-10-31

Pharmacologic Class

Established (EPC)
vitamin c [epc] vitamin d [epc] vitamin b12 [epc] vitamin k [epc] warfarin reversal agent [epc]
Chemical Structure
ascorbic acid [cs] vitamin d [cs] vitamin b 12 [cs] vitamin k [cs]
Physiologic Effect
increased prothrombin activity [pe] reversed anticoagulation activity [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 546439031
Hyphenated Format 54643-9031

Supplemental Identifiers

RxCUI
1305217 1305222
UNII
9E8X80D2L0 PQ6CK8PD0R 6SO6U10H04 1C6V77QF41 P6YC3EG204 1O6C93RI7Z 935E97BOY8 25X51I8RD4 A034SE7857 68Y4CF58BV 20RD1DZH99 M572600E5P 1D1K0N0VVC
NUI
N0000193618 M0001797 M0022797 N0000175952 M0022794 N0000175951 N0000175965 N0000175982 M0022806 N0000180191 N0000175966

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name pediatric infuvite multiple vitamins (source: ndc)
Generic 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 (source: ndc)
Application Number NDA021646 (source: ndc)
Routes
intravenous
source: label

Resolved Composition

Strengths
  • 4 ml
  • 1 ml
  • 40 ml
  • 50 ml
  • 10 ml
  • 1.5 ml
  • 3.25 ml
  • 5 ml
source: label
Packaging
  • 1 KIT in 1 CARTON (54643-9031-0) * 40 mL in 1 VIAL * 10 mL in 1 VIAL
source: ndc

Packages (1)

54643-9031-0 1 KIT in 1 CARTON (54643-9031-0) * 40 mL in 1 VIAL * 10 mL in 1 VIAL

Ingredients (0)

No ingredient records.

Linked Drug Pages (1)

Pediatric Infuvite Multiple Vitamins ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"spl_id": "447b597f-d7fe-4489-b755-9929b40032f4", "openfda": {"nui": ["N0000193618", "M0001797", "M0022797", "N0000175952", "M0022794", "N0000175951", "N0000175965", "N0000175982", "M0022806", "N0000180191", "N0000175966"], "unii": ["9E8X80D2L0", "PQ6CK8PD0R", "6SO6U10H04", "1C6V77QF41", "P6YC3EG204", "1O6C93RI7Z", "935E97BOY8", "25X51I8RD4", "A034SE7857", "68Y4CF58BV", "20RD1DZH99", "M572600E5P", "1D1K0N0VVC"], "rxcui": ["1305217", "1305222"], "spl_set_id": ["4ff223f7-e076-4e81-8151-5c06724fabd9"], "pharm_class_cs": ["Ascorbic Acid [CS]", "Vitamin D [CS]", "Vitamin B 12 [CS]", "Vitamin K [CS]"], "pharm_class_pe": ["Increased Prothrombin Activity [PE]", "Reversed Anticoagulation Activity [PE]"], "pharm_class_epc": ["Vitamin C [EPC]", "Vitamin D [EPC]", "Vitamin B12 [EPC]", "Vitamin K [EPC]", "Warfarin Reversal Agent [EPC]"], "manufacturer_name": ["Sandoz Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 KIT in 1 CARTON (54643-9031-0)  *  40 mL in 1 VIAL *  10 mL in 1 VIAL", "package_ndc": "54643-9031-0", "marketing_end_date": "20261031", "marketing_start_date": "20240630"}], "brand_name": "Pediatric Infuvite Multiple Vitamins", "product_id": "54643-9031_447b597f-d7fe-4489-b755-9929b40032f4", "dosage_form": "KIT", "product_ndc": "54643-9031", "generic_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", "labeler_name": "Sandoz Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Pediatric Infuvite Multiple Vitamins", "application_number": "NDA021646", "marketing_category": "NDA", "marketing_end_date": "20261031", "marketing_start_date": "20161223"}