Cyanocobalamin

Product NDC
0143-9619
11-digit product format
001439619
Labeler code
0143
Product ID
0143-9619_58925d4c-edff-43c6-9c9b-07102e84e41f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
cyanocobalamin
Dosage form
INJECTION
Route
INTRAMUSCULAR; SUBCUTANEOUS
Labeler
Hikma Pharmaceuticals USA Inc.
Application
ANDA080515
Marketing category
ANDA
Marketing start
1971-10-20
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
0143-9619-01Cyanocobalamin30 mL in 1 VIAL, MULTI-DOSEINJECTION3010
0143-9619-10Cyanocobalamin10 in 1 BOXINJECTION1010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0143-9619-01ML - Milliliter0143-96198a984ce6-eb50-48dd-8447-5fb9e532be2c12016-05-16
0143-9619-10ML - Milliliter0143-96190b9d66fc-3997-40f5-b953-9d017f983f7212016-05-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0143-9619CYANOCOBALAMIN INJECTION [HIKMA PHARMACEUTICALS USA INC.]9Current NDC, Legacy NDC, 2 package rows20240424_a66eb3c4-3e1d-4d49-b963-4fa2334cc9b6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309594cyanocobalamin 1000 MCG/ML Injectable SolutionPSNa66eb3c4-3e1d-4d49-b963-4fa2334cc9b610
309594vitamin B12 1 MG/ML Injectable SolutionSCDa66eb3c4-3e1d-4d49-b963-4fa2334cc9b610
309594cyanocobalamin 1 MG/ML Injectable SolutionSYa66eb3c4-3e1d-4d49-b963-4fa2334cc9b610
309594cyanocobalamin 1000 MCG/ML Injectable SolutionSYa66eb3c4-3e1d-4d49-b963-4fa2334cc9b610
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
0143-9619-010014396190130 mL in 1 VIAL, MULTI-DOSE (0143-9619-01) 30 ml1971-10-20NoNoHistorical
0143-9619-100014396191010 VIAL, MULTI-DOSE in 1 BOX (0143-9619-10) / 30 mL in 1 VIAL, MULTI-DOSE (0143-9619-01) 1971-10-200000-00-00NoNoCurrent