Cyanocobalamin

Product NDC
0517-0130
11-digit product format
005170130
Labeler code
0517
Product ID
0517-0130_28421ba1-7e37-429c-9c66-62cc36f5847c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
cyanocobalamin
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR; SUBCUTANEOUS
Labeler
American Regent, Inc.
Application
ANDA080737
Marketing category
ANDA
Marketing start
2003-05-29
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
0517-0130-01Cyanocobalamin1 in 1 BOXINJECTION, SOLUTION112
0517-0130-01Cyanocobalamin30 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION3012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0517-0130-01ML - Milliliter0517-013086eb5f38-6f72-489e-94ed-58fdb6bc85b612019-08-06
0517-0130-05ML - Milliliter0517-0130a0336369-2b53-46f6-a047-3d2860111f8712012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CYANOCOBALAMINACTIVE INGREDIENTP6YC3EG204CYANOCOBALAMIN INJECTION, SOLUTION [AMERICAN REGENT, INC.]5
CYANOCOBALAMINACTIVE MOIETYP6YC3EG204CYANOCOBALAMIN INJECTION, SOLUTION [AMERICAN REGENT, INC.]5
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHCYANOCOBALAMIN INJECTION, SOLUTION [AMERICAN REGENT, INC.]5
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XCYANOCOBALAMIN INJECTION, SOLUTION [AMERICAN REGENT, INC.]5
WATERINACTIVE INGREDIENT059QF0KO0RCYANOCOBALAMIN INJECTION, SOLUTION [AMERICAN REGENT, INC.]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0517-0130CYANOCOBALAMIN INJECTION, SOLUTION [AMERICAN REGENT, INC.]12Current NDC, Legacy NDC, 2 package rows20231101_2fb653d6-e2b2-4969-831b-c0dc37b9c0cc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309594cyanocobalamin 1000 MCG/ML Injectable SolutionPSN2fb653d6-e2b2-4969-831b-c0dc37b9c0cc12
309594vitamin B12 1 MG/ML Injectable SolutionSCD2fb653d6-e2b2-4969-831b-c0dc37b9c0cc12
309594cyanocobalamin 1 MG/ML Injectable SolutionSY2fb653d6-e2b2-4969-831b-c0dc37b9c0cc12
309594cyanocobalamin 1000 MCG/ML Injectable SolutionSY2fb653d6-e2b2-4969-831b-c0dc37b9c0cc12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0517-0130-01005170130011 VIAL, MULTI-DOSE in 1 BOX (0517-0130-01) / 30 mL in 1 VIAL, MULTI-DOSE2003-05-290000-00-00NoNoCurrent