Cyanocobalamin

Product NDC
71288-302
11-digit product format
712880302
Labeler code
71288
Product ID
71288-302_b2ee60e7-c10a-45e1-81e8-28d6838161eb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cyanocobalamin
Dosage form
INJECTION
Route
INTRAMUSCULAR; SUBCUTANEOUS
Labeler
Meitheal Pharmaceuticals Inc.
Application
ANDA214316
Marketing category
ANDA
Marketing start
2024-11-15
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
71288-302-30Cyanocobalamin30 mL in 1 VIAL, MULTI-DOSEINJECTION303
71288-302-30Cyanocobalamin1 in 1 CARTONINJECTION13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71288-302CYANOCOBALAMIN INJECTION [MEITHEAL PHARMACEUTICALS INC.]3Current NDC, 2 package rows20241127_9c37fd25-2143-410c-8d89-d39aa5c7b453.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309594cyanocobalamin 1000 MCG/ML Injectable SolutionPSN9c37fd25-2143-410c-8d89-d39aa5c7b4533
309594vitamin B12 1 MG/ML Injectable SolutionSCD9c37fd25-2143-410c-8d89-d39aa5c7b4533
309594cyanocobalamin 1 MG/ML Injectable SolutionSY9c37fd25-2143-410c-8d89-d39aa5c7b4533
309594cyanocobalamin 1000 MCG/ML Injectable SolutionSY9c37fd25-2143-410c-8d89-d39aa5c7b4533

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71288-302-30712880302301 VIAL, MULTI-DOSE in 1 CARTON (71288-302-30) / 30 mL in 1 VIAL, MULTI-DOSE2024-11-15NoNoCurrent