FDA.reportPublic FDA data

cyanocobalamin

Product NDC
70069-172
11-digit product format
700690172
Labeler code
70069
Product ID
70069-172_a10756d3-74a9-4adf-9d2a-0bbac8ad941b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
cyanocobalamin
Dosage form
INJECTION
Route
INTRAMUSCULAR; SUBCUTANEOUS
Labeler
Somerset Therapeutics, LLC
Application
ANDA206503
Marketing category
ANDA
Marketing start
2017-06-27
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
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70069-172-01cyanocobalamin10 mL in 1 VIALINJECTION1010
70069-172-10cyanocobalamin10 in 1 CARTONINJECTION1010
70069-172-25cyanocobalamin25 in 1 CARTONINJECTION2510

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70069-172-01ML - Milliliter70069-1723bf7f3d7-b01c-4aac-b279-faa8f785debd12017-08-11
70069-172-10ML - Milliliter70069-172d900c330-a83d-4209-ac2f-24eaa2969b5f12017-08-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70069-172CYANOCOBALAMIN INJECTION [SOMERSET THERAPEUTICS, LLC]9Current NDC, Legacy NDC, 3 package rows20231221_41ac0dc1-0a71-4c69-8e25-ba838f5f16a3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309594cyanocobalamin 1000 MCG/ML Injectable SolutionPSN41ac0dc1-0a71-4c69-8e25-ba838f5f16a310
309594vitamin B12 1 MG/ML Injectable SolutionSCD41ac0dc1-0a71-4c69-8e25-ba838f5f16a310
309594cyanocobalamin 1 MG/ML Injectable SolutionSY41ac0dc1-0a71-4c69-8e25-ba838f5f16a310
309594cyanocobalamin 1000 MCG/ML Injectable SolutionSY41ac0dc1-0a71-4c69-8e25-ba838f5f16a310

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70069-172-017006901720110 mL in 1 VIAL10 mlHistorical
70069-172-107006901721010 VIAL in 1 CARTON (70069-172-10) / 10 mL in 1 VIAL (70069-172-01) 10 vial2017-06-270000-00-00NoNoCurrent
70069-172-257006901722525 VIAL in 1 CARTON (70069-172-25) / 10 mL in 1 VIAL (70069-172-01) 25 vial2017-06-270000-00-00NoNoCurrent