FDA.reportPublic FDA data

Multiple Vitamins (Adult) Single Dose

Product NDC
60505-6172
Requested package NDC
60505-6172-0
11-digit product format
605056172
Labeler code
60505
Product ID
60505-6172_3e2cf3a3-1fc3-3a73-1d7e-c4a1ee3ea2f5
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
ANDA210273
Marketing category
ANDA
Marketing start
2026-06-04
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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A210273-001MULTIPLE VITAMINS INJECTION ADULTALPHA-TOCOPHEROL ACETATE; ASCORBIC ACID; BIOTIN; CHOLECALCIFEROL; CYANOCOBALAMIN; DEXPANTHENOL; FOLIC ACID; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN 5'-PHOSPHATE SODIUM; THIAMINE HYDROCHLORIDE; VITAMIN A PALMITATE; VITAMIN K2 IU/ML;40MG/ML;12MCG/ML;40 IU/ML;1MCG/ML;3MG/ML;120MCG/ML;8MG/ML;1.2MG/ML;0.72MG/ML;1.2MG/ML;660 IU/ML;0.03MG/MLSOLUTION / INTRAVENOUSAP2026-04-09

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A210273-001AP

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A210273-001MULTIPLE VITAMINS INJECTION ADULT2 IU/ML;40MG/ML;12MCG/ML;40 IU/ML;1MCG/ML;3MG/ML;120MCG/ML;8MG/ML;1.2MG/ML;0.72MG/ML;1.2MG/ML;660 IU/ML;0.03MG/MLSOLUTION / INTRAVENOUSAP2026-04-0984e616aacf4f…
2026-08-18 06:07:402026-07A210273-001MULTIPLE VITAMINS INJECTION ADULT2 IU/ML;40MG/ML;12MCG/ML;40 IU/ML;1MCG/ML;3MG/ML;120MCG/ML;8MG/ML;1.2MG/ML;0.72MG/ML;1.2MG/ML;660 IU/ML;0.03MG/MLSOLUTION / INTRAVENOUSAP2026-04-09caaa826d4ba7…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A210273-001MULTIPLE VITAMINS INJECTION ADULT2 IU/ML;40MG/ML;12MCG/ML;40 IU/ML;1MCG/ML;3MG/ML;120MCG/ML;8MG/ML;1.2MG/ML;0.72MG/ML;1.2MG/ML;660 IU/ML;0.03MG/MLSOLUTION / INTRAVENOUSAP2026-04-09a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A210273-001AP184e616aacf4f…
2026-08-18 06:07:402026-07A210273-001AP1caaa826d4ba7…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A210273-001AP1a50c72e98297…

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 (Adult) Single Dose
Listing expiration
2027-12-31

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
83d65db4-7771-063d-909a-5aa29b945ee1Available 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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Multiple Vitamins (Adult) Single DoseASCORBIC ACID, VITAMIN A PALMITATE, CHOLECALCIFEROL, THIAMINE HYDROCHLORIDE, RIBOFLAVIN 5-PHOSPHATE SODIUM, PYRIDOXINE HYDROCHLORIDE, NIACINAMIDE, DEXPANTHENOL, ALPHA-TOCOPHEROL ACETATE, VITAMIN K1, FOLIC ACID, BIOTIN, CYANOCOBALAMINApotex Corp83d65db4-7771-063d-909a-5aa29b945ee12026-06-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210273
application number: ANDA210273
ndc (package): 60505-6172-0
ndc (product): 60505-6172
ndc11 (package): 60505617200

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
60505-6172-0605056172001 KIT in 1 CARTON (60505-6172-0) * 5 mL in 1 VIAL (60505-6299-1) * 5 mL in 1 VIAL (60505-6300-2) 1 kit2026-06-04NoNoCurrent