cyanocobalamin

Product NDC
76420-075
11-digit product format
764200075
Labeler code
76420
Product ID
76420-075_ead2d6e4-62f5-3b3c-e053-2a95a90a4ccd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
cyanocobalamin
Dosage form
INJECTION
Route
INTRAMUSCULAR; SUBCUTANEOUS
Labeler
Asclemed USA, Inc.
Application
ANDA206503
Marketing category
ANDA
Marketing start
2015-12-11
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
76420-075-25cyanocobalamin25 in 1 CARTONINJECTION252
76420-075-25cyanocobalamin1 mL in 1 VIALINJECTION12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
76420-075-25ML - Milliliter76420-07524071165-6b54-4fdf-8709-ae2711e20f7b12023-03-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76420-075CYANOCOBALAMIN INJECTION [ASCLEMED USA, INC.]2Current NDC, Legacy NDC, 2 package rows20221013_d589cc00-a896-4a6b-b93c-a049c8af6973.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309594cyanocobalamin 1000 MCG/ML Injectable SolutionPSNd589cc00-a896-4a6b-b93c-a049c8af69732
309594vitamin B12 1 MG/ML Injectable SolutionSCDd589cc00-a896-4a6b-b93c-a049c8af69732
309594cyanocobalamin 1 MG/ML Injectable SolutionSYd589cc00-a896-4a6b-b93c-a049c8af69732
309594cyanocobalamin 1000 MCG/ML Injectable SolutionSYd589cc00-a896-4a6b-b93c-a049c8af69732

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
76420-075-257642000752525 VIAL in 1 CARTON (76420-075-25) / 1 mL in 1 VIAL25 vial2020-01-040000-00-00NoNoCurrent