Pediatric Infuvite Multiple Vitamins

Product NDC: 54643-9023
Requested package NDC: 54643-9023-1
11-digit product format: 546439023
Labeler code: 54643
Product ID: 54643-9023_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: INJECTION, SOLUTION
Route: INTRAVENOUS
Labeler: Sandoz Inc
Application: NDA021265
Marketing category: NDA
Marketing start: 2016-12-23
Marketing end: 2026-10-31
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; 80; 20; 400; 1; 5; 140; 17; .2; 1; 1.4; 1.2; 2300 [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], Photoabsorption [MoA], Photoenhancer [EPC], Photosensitizing 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
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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 2 · 80 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
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…`
2021-12-28 21:50 UTC	2021-12	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	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	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	`782e0a99824c…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
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…`

Additional Listing Data#

Finished product: Yes
Brand name base: Pediatric Infuvite Multiple Vitamins

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ASCORBIC ACID	7 [iU]/5mL
VITAMIN A PALMITATE	80 mg/5mL
CHOLECALCIFEROL	20 ug/5mL
THIAMINE HYDROCHLORIDE	400 [iU]/5mL
RIBOFLAVIN 5'-PHOSPHATE SODIUM	1 ug/5mL
PYRIDOXINE HYDROCHLORIDE	5 mg/5mL
NIACINAMIDE	140 ug/5mL
DEXPANTHENOL	17 mg/5mL
.ALPHA.-TOCOPHEROL ACETATE	.2 mg/5mL
PHYTONADIONE	1 mg/5mL
FOLIC ACID	1.4 mg/5mL
BIOTIN	1.2 mg/5mL
CYANOCOBALAMIN	2300 [iU]/5mL

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
54643-9023-1	Pediatric Infuvite Multiple Vitamins	10 in 1 CARTON	INJECTION, SOLUTION	10		7
54643-9023-1	Pediatric Infuvite Multiple Vitamins	5 mL in 1 VIAL	INJECTION, SOLUTION	5		7

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
54643-9023-1	ML - Milliliter	54643-9023	fbc145cb-29d9-4890-9387-e8d4fd5f877f	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 · 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 ndc (package): 54643-9023-1 ndc (product): 54643-9023 ndc11 (package): 54643902301
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

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
54643-9023-1	54643902301	10 VIAL in 1 CARTON (54643-9023-1) / 5 mL in 1 VIAL	10 vial	2016-12-23	2026-10-31	No	No	Current