cyanocobalamin

Product NDC
85766-029
11-digit product format
857660029
Labeler code
85766
Product ID
85766-029_4a16b021-f8d6-e66e-e063-6294a90a4683
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
cyanocobalamin
Dosage form
INJECTION
Route
INTRAMUSCULAR; SUBCUTANEOUS
Labeler
Sportpharm LLC
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
cyanocobalamin
Listing expiration
2027-12-31

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
85766-029-01cyanocobalamin1 mL in 1 VIALINJECTION12
85766-029-25cyanocobalamin25 in 1 CARTONINJECTION252

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309594cyanocobalamin 1000 MCG/ML Injectable SolutionPSN647842f4-b211-4f52-8b73-975fae7670232
309594vitamin B12 1 MG/ML Injectable SolutionSCD647842f4-b211-4f52-8b73-975fae7670232
309594cyanocobalamin 1 MG/ML Injectable SolutionSY647842f4-b211-4f52-8b73-975fae7670232
309594cyanocobalamin 1000 MCG/ML Injectable SolutionSY647842f4-b211-4f52-8b73-975fae7670232

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85766-029-01857660029011 mL in 1 VIAL1 mlHistorical
85766-029-258576600292525 VIAL in 1 CARTON (85766-029-25) / 1 mL in 1 VIAL (85766-029-01) 25 vial2025-08-07NoNoHistorical