Multiple Vitamins (Pediatric) Pharmacy Bulk Package

Product NDC: 60505-6171
Requested package NDC: 60505-6171-0
11-digit product format: 605056171
Labeler code: 60505
Product ID: 60505-6171_9fb418a2-c16d-0000-01b8-c8fd7ad95b60
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Asorbic 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
Route: INTRAVENOUS
Labeler: Apotex Corp
Application: ANDA210456
Marketing category: ANDA
Marketing start: 2026-07-01
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A210456-001	MULTIPLE VITAMINS INJECTION 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		2026-04-21

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A210456-001	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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A210456-001	MULTIPLE VITAMINS INJECTION 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	2026-04-21	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A210456-001	MULTIPLE VITAMINS INJECTION 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	2026-04-21	`caaa826d4ba7…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A210456-001	MULTIPLE VITAMINS INJECTION 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	2026-04-21	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A210456-001	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A210456-001	AP	1	`caaa826d4ba7…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A210456-001	AP	1	`a50c72e98297…`

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: Multiple Vitamins (Pediatric) Pharmacy Bulk Package
Listing expiration: 2027-12-31

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
d9b6eb9a-4218-5c94-6e35-7cbbf0fba494	Available on FDA.report

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
Multiple Vitamins (Pediatric) Pharmacy Bulk Package	ASORBIC ACID, VITAMIN A PALMITATE, CHOLECALCIFEROL, THIAMINE HYDROCHLORIDE, RIBOFLAVIN-5 PHOSPHATE SODIUM, PYRIDOXINE HYDROCHLORIDE, NIACINAMIDE, DEXPANTHENOL, ALPHA-TOCOPHEROL ACETATE, VITAMIN K1, FOLIC ACID, BIOTIN, CYANOCOBALAMIN	Apotex Corp	d9b6eb9a-4218-5c94-6e35-7cbbf0fba494	2026-07-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210456 application number: ANDA210456 ndc (package): 60505-6171-0 ndc (product): 60505-6171 ndc11 (package): 60505617100

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
60505-6171-0	60505617100	1 KIT in 1 CARTON (60505-6171-0) * 40 mL in 1 VIAL (60505-6295-1) * 10 mL in 1 VIAL (60505-6296-2)	1 kit	2026-07-01	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Multiple Vitamins (Pediatric) Pharmacy Bulk Package	Apotex Corp \| Apotex Inc.	2026-07-02	HUMAN PRESCRIPTION DRUG LABEL	2