Pediatric Infuvite Multiple Vitamins

Product NDC: 54643-9031
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
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…`

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
Identifier	FDA.report destination
PQ6CK8PD0R	Internal UNII lookup
1D1K0N0VVC	Internal UNII lookup
1C6V77QF41	Internal UNII lookup
M572600E5P	Internal UNII lookup
20RD1DZH99	Internal UNII lookup
68Y4CF58BV	Internal UNII lookup
25X51I8RD4	Internal UNII lookup
1O6C93RI7Z	Internal UNII lookup
9E8X80D2L0	Internal UNII lookup
A034SE7857	Internal UNII lookup
935E97BOY8	Internal UNII lookup
6SO6U10H04	Internal UNII lookup
P6YC3EG204	Internal UNII lookup

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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
4ff223f7-e076-4e81-8151-5c06724fabd9	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
16a2c1cd-ae95-d910-f03d-7e06b11dd243	Product name	5	20260202
653485de-0601-41e4-82db-7a60bb223e27	Product name	1	20251024
cf050ccd-1144-f76a-e00d-e5698d8597d4	Product name	6	20250625
59361619-24d9-b610-eca6-5a7f25ed5e03	Product name	5	20240909
23fb3cda-2b50-f3d3-ebde-f542350bd77b	Product name	4	20240828
b82b4008-22fd-05f5-6cc6-c0a6e81c65b8	Product name	2	20240805
081b54f0-4545-48b6-b854-03e1401f09ea	Product name	1	20230112
a62a50ac-1535-4461-9768-8ae703e2e9fb	Product name	1	20210525
91c62db0-0295-c81c-d10a-0856c259edd6	Product name	2	20200428
d32bc2b8-0bb7-2216-87aa-24639646e202	Product name	3	20190619
aead65a2-216e-4ff8-a178-44aab77c24ed	Product name	1	20180531
c5cd4727-ac49-4409-82b1-5bd8006c3ec7	Product name	1	20171122
d206bb34-ea65-399d-70d9-834f22dc2c18	Product name	3	20170724
5e18e798-5614-cf5c-0185-38b1cb77a093	Product name	2	20160822
60c52429-fcef-eb54-2387-43bc9e4f296b	Product name	1	20140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508
bc07ef78-e82d-0c19-31f4-31f263780582	Product name	1	20140508

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
54643-9031-0	ML - Milliliter	54643-9031	024cc817-3523-4b06-8971-2795463fedee	1	2017-07-07

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
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	2024-06-30	2026-10-31	No	No	Current