Cyanocobalamin

Product NDC
25021-502
11-digit product format
250210502
Labeler code
25021
Product ID
25021-502_b1dd7657-05bd-4062-89f1-9e11f0042f3e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cyanocobalamin
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR; SUBCUTANEOUS
Labeler
Sagent Pharmaceuticals
Application
ANDA215107
Marketing category
ANDA
Marketing start
2023-03-15
Substance
CYANOCOBALAMIN
Active strength
1000 ug/mL
Pharmacologic classes
Vitamin B 12 [CS], Vitamin B12 [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Cyanocobalamin
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CYANOCOBALAMIN1000 ug/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiP6YC3EG204
Rxcui309594

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b82b4008-22fd-05f5-6cc6-c0a6e81c65b8Product name220240805
d206bb34-ea65-399d-70d9-834f22dc2c18Product name320170724

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
25021-502-01Cyanocobalamin1 mL in 1 VIALINJECTION, SOLUTION14
25021-502-01Cyanocobalamin25 in 1 CARTONINJECTION, SOLUTION254

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
25021-502-01ML - Milliliter25021-502af977045-90c1-43c2-a271-2516db22808f12023-05-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
25021-502CYANOCOBALAMIN INJECTION, SOLUTION [SAGENT PHARMACEUTICALS]4Current NDC, 2 package rows20230315_7e10c47d-1036-47c1-a0ed-6929636366c2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309594cyanocobalamin 1000 MCG/ML Injectable SolutionPSN7e10c47d-1036-47c1-a0ed-6929636366c24
309594vitamin B12 1 MG/ML Injectable SolutionSCD7e10c47d-1036-47c1-a0ed-6929636366c24
309594cyanocobalamin 1 MG/ML Injectable SolutionSY7e10c47d-1036-47c1-a0ed-6929636366c24
309594cyanocobalamin 1000 MCG/ML Injectable SolutionSY7e10c47d-1036-47c1-a0ed-6929636366c24

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
25021-502-012502105020125 VIAL in 1 CARTON (25021-502-01) / 1 mL in 1 VIAL25 vial2023-03-15NoNoHistorical