Pediatric Infuvite Multiple Vitamins

Product NDC: 54643-7886
11-digit product format: 546437886
Labeler code: 54643
Product ID: 54643-7886_a2d6735d-ba42-4c15-9dc9-90e18f15e443
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: NDA021265
Marketing category: NDA
Marketing start: 2001-02-21
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: 7 [iU]/5mL; mg/5mL; ug/5mL; [iU]/5mL; ug/5mL; mg/5mL; ug/5mL; mg/5mL; mg/5mL; mg/5mL; mg/5mL; mg/5mL; [iU]/5mL
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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	54643-7886		D	Discontinued by firm		2026-08-17
excluded package	package	54643-7886	54643-7886-1	D	Discontinued by firm		2026-08-17

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 · 4 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	54643-7886-1	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	54643-7886-1	`f5e01cc5f278…`	`a2eaf40c39c3…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N021265-001	INFUVITE PEDIATRIC	ASCORBIC ACID; BIOTIN; CHOLECALCIFEROL; CYANOCOBALAMIN; DEXPANTHENOL; FOLIC ACID; NIACINAMIDE; PYRIDOXINE; RIBOFLAVIN; THIAMINE; TOCOPHEROL ACETATE; VITAMIN A; VITAMIN K	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	AP	RLD, RS	2001-02-21
N021265-002	INFUVITE PEDIATRIC (PHARMACY BULK PACKAGE)	ASCORBIC ACID; BIOTIN; CHOLECALCIFEROL; CYANOCOBALAMIN; DEXPANTHENOL; FOLIC ACID; NIACINAMIDE; PYRIDOXINE; RIBOFLAVIN; THIAMINE; TOCOPHEROL ACETATE; VITAMIN A; VITAMIN K	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	AP	RLD, RS	2004-01-29

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
N021265-001	AP
N021265-002	AP

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.

Product history page 1 of 3 · 82 observed 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
2026-08-18 06:07:40	2026-07	N021265-001	INFUVITE PEDIATRIC	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	AP	RLD, RS	2001-02-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021265-002	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	AP	RLD, RS	2004-01-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021265-001	INFUVITE PEDIATRIC	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	2001-02-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021265-002	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	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021265-001	INFUVITE PEDIATRIC	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	2001-02-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021265-002	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	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021265-001	INFUVITE PEDIATRIC	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	2001-02-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021265-002	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	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021265-001	INFUVITE PEDIATRIC	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	2001-02-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021265-002	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	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021265-001	INFUVITE PEDIATRIC	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	2001-02-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021265-002	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	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021265-001	INFUVITE PEDIATRIC	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	2001-02-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021265-002	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	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021265-001	INFUVITE PEDIATRIC	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	2001-02-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021265-002	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	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021265-001	INFUVITE PEDIATRIC	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	2001-02-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021265-002	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	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021265-001	INFUVITE PEDIATRIC	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	2001-02-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021265-002	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	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021265-001	INFUVITE PEDIATRIC	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	2001-02-21	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021265-002	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	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021265-001	INFUVITE PEDIATRIC	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	2001-02-21	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021265-002	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	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021265-001	INFUVITE PEDIATRIC	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	2001-02-21	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021265-002	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	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021265-001	INFUVITE PEDIATRIC	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	2001-02-21	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021265-002	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	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021265-001	INFUVITE PEDIATRIC	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	2001-02-21	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N021265-002	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	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021265-001	INFUVITE PEDIATRIC	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	2001-02-21	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021265-002	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	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021265-001	INFUVITE PEDIATRIC	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	2001-02-21	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021265-002	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	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021265-001	INFUVITE PEDIATRIC	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	2001-02-21	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021265-002	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	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021265-001	INFUVITE PEDIATRIC	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	2001-02-21	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021265-002	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	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021265-001	INFUVITE PEDIATRIC	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	2001-02-21	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021265-002	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	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	N021265-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021265-002	AP	1	`caaa826d4ba7…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N021265-001	AP	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N021265-002	AP	1	`a50c72e98297…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
54643-7886-1	ML - Milliliter	54643-7886	191776df-3663-4a48-8a27-47916ec7e4b0	1	2017-07-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
54643-7886	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) KIT 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) INJECTION, SOLUTION [SANDOZ INC]	6	Legacy NDC	20221129_02064c66-3f2d-4502-a96d-800a4d128593.zip

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 · 2 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): 021265 application number: NDA021265
Infuvite Pediatric	MULTIPLE VITAMINS INJECTION	Sandoz Inc	6d06546e-8b0a-4490-82d9-397bd902a044	2024-11-20	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021265 application number: NDA021265

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
9E8X80D2L0	.ALPHA.-TOCOPHEROL ACETATE	7695-91-2	.ALPHA.-TOCOPHEROL ACETATE
PQ6CK8PD0R	ASCORBIC ACID	50-81-7	ASCORBIC ACID
6SO6U10H04	BIOTIN	58-85-5	BIOTIN
1C6V77QF41	CHOLECALCIFEROL	67-97-0	CHOLECALCIFEROL
P6YC3EG204	CYANOCOBALAMIN	68-19-9	CYANOCOBALAMIN
1O6C93RI7Z	DEXPANTHENOL	81-13-0	DEXPANTHENOL
935E97BOY8	FOLIC ACID	59-30-3	FOLIC ACID
25X51I8RD4	NIACINAMIDE	98-92-0	NIACINAMIDE
A034SE7857	PHYTONADIONE		PHYTONADIONE
68Y4CF58BV	PYRIDOXINE HYDROCHLORIDE	58-56-0	PYRIDOXINE HYDROCHLORIDE
20RD1DZH99	RIBOFLAVIN 5'-PHOSPHATE SODIUM	6184-17-4	RIBOFLAVIN 5'-PHOSPHATE SODIUM
M572600E5P	THIAMINE HYDROCHLORIDE	67-03-8	THIAMINE HYDROCHLORIDE
1D1K0N0VVC	VITAMIN A PALMITATE	79-81-2	VITAMIN A PALMITATE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
54643-7886-1	54643788601	10 VIAL in 1 CARTON (54643-7886-1) > 5 mL in 1 VIAL	10 vial	2016-12-23	0000-00-00	No	No	Current