CYANOCOBALAMIN

Product NDC
51662-1394
11-digit product format
516621394
Labeler code
51662
Product ID
51662-1394_10322444-6e5a-3ab9-e063-6294a90a7b2b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CYANOCOBALAMIN
Dosage form
INJECTION
Route
INTRAMUSCULAR; SUBCUTANEOUS
Labeler
HF Acquisition Co LLC, DBA HealthFirst
Application
ANDA080515
Marketing category
ANDA
Marketing start
2019-10-18
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
51662-1394-1CYANOCOBALAMIN30 mL in 1 VIAL, MULTI-DOSEINJECTION305
51662-1394-2CYANOCOBALAMIN1 mL in 1 POUCHINJECTION15
51662-1394-3CYANOCOBALAMIN10 in 1 CASEINJECTION105

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51662-1394CYANOCOBALAMIN INJECTION [HF ACQUISITION CO LLC, DBA HEALTHFIRST]5Current NDC, Legacy NDC, 3 package rows20240131_953aa8c6-31ce-0c3b-e053-2a95a90ab35f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309594cyanocobalamin 1000 MCG/ML Injectable SolutionPSN953aa8c6-31ce-0c3b-e053-2a95a90ab35f5
309594vitamin B12 1 MG/ML Injectable SolutionSCD953aa8c6-31ce-0c3b-e053-2a95a90ab35f5
309594cyanocobalamin 1 MG/ML Injectable SolutionSY953aa8c6-31ce-0c3b-e053-2a95a90ab35f5
309594cyanocobalamin 1000 MCG/ML Injectable SolutionSY953aa8c6-31ce-0c3b-e053-2a95a90ab35f5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51662-1394-15166213940130 mL in 1 VIAL, MULTI-DOSE (51662-1394-1) 30 ml2019-10-180000-00-00NoNoCurrent
51662-1394-2516621394021 mL in 1 POUCH1 mlHistorical
51662-1394-35166213940310 POUCH in 1 CASE (51662-1394-3) / 1 mL in 1 POUCH (51662-1394-2) 10 pouch2021-01-120000-00-00NoNoCurrent