Home NDC 60505-6190 Multiple Vitamins (Pediatric) Single Dose Vial
Product NDC 60505-6190
11-digit product format 605056190
Labeler code 60505
Product ID 60505-6190_3fbb6b6d-1476-8547-6896-fd474c59d8bd
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 Apotex Corp.
Application ANDA210671
Marketing category ANDA
Marketing start 2026-06-24
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 A210671-001 MULTIPLE VITAMINS INJECTION 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 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 A210671-001 AP
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 1 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration A210671-001 CGT 2026-12-21
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 2026-09-14 22:38:34 2026-08 A210671-001 MULTIPLE VITAMINS INJECTION 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 2026-04-21 84e616aacf4f…2026-08-18 06:07:40 2026-07 A210671-001 MULTIPLE VITAMINS INJECTION 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 2026-04-21 caaa826d4ba7…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A210671-001 MULTIPLE VITAMINS INJECTION 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 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 A210671-001 AP 1 84e616aacf4f…2026-08-18 06:07:40 2026-07 A210671-001 AP 1 caaa826d4ba7…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A210671-001 AP 1 a50c72e98297…
Observed Orange Book exclusivity history# Captured, Edition, Application-product table Captured Edition Application-product Exclusivity code Expiration Source SHA-256 2026-09-14 22:38:34 2026-08 A210671-001 CGT 2026-12-21 84e616aacf4f…2026-08-18 06:07:40 2026-07 A210671-001 CGT 2026-12-21 caaa826d4ba7…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A210671-001 CGT 2026-12-21 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) Single Dose Vial
Listing expiration 2027-12-31 Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
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) Single Dose Vial 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 Apotex Corp. 490083f3-f56f-c884-bc7d-21eeffb20168 2026-06-24 Warnings, Adverse reactions Exact identifier application applno (ANDA): 210671 application number: ANDA210671 ndc (product): 60505-6190
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 60505-6190-0 60505619000 1 KIT in 1 CARTON (60505-6190-0) * 4 mL in 1 VIAL (60505-6297-1) * 1 mL in 1 VIAL (60505-6298-2) 1 kit 2026-06-24 No No Current