Cyanocobalamin

Product NDC
68001-542
11-digit product format
680010542
Labeler code
68001
Product ID
68001-542_fab6a2d8-d9a0-2f8f-e053-6394a90a22bc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cyanocobalamin
Dosage form
INJECTION, SOLUTION
Route
SUBCUTANEOUS
Labeler
BluePoint Laboratories
Application
ANDA080737
Marketing category
ANDA
Marketing start
2022-06-24
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
68001-542-59Cyanocobalamin1 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION12
68001-542-60Cyanocobalamin25 in 1 TRAYINJECTION, SOLUTION252

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68001-542-59ML - Milliliter68001-54290ed8af4-f26f-4c6a-8c76-74fd5396701f12022-09-12
68001-542-60ML - Milliliter68001-542c324638e-82c4-4d3c-9792-04abf916d2a812022-09-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68001-542CYANOCOBALAMIN INJECTION, SOLUTION [BLUEPOINT LABORATORIES]2Current NDC, Legacy NDC, 2 package rows20230506_cdd4fd12-e214-43a6-b560-d56fc0d87190.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309594cyanocobalamin 1000 MCG/ML Injectable SolutionPSNcdd4fd12-e214-43a6-b560-d56fc0d871902
309594vitamin B12 1 MG/ML Injectable SolutionSCDcdd4fd12-e214-43a6-b560-d56fc0d871902
309594cyanocobalamin 1 MG/ML Injectable SolutionSYcdd4fd12-e214-43a6-b560-d56fc0d871902
309594cyanocobalamin 1000 MCG/ML Injectable SolutionSYcdd4fd12-e214-43a6-b560-d56fc0d871902

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68001-542-59680010542591 mL in 1 VIAL, MULTI-DOSE1 mlHistorical
68001-542-606800105426025 VIAL, MULTI-DOSE in 1 TRAY (68001-542-60) / 1 mL in 1 VIAL, MULTI-DOSE (68001-542-59) 2022-06-240000-00-00NoNoCurrent