CYANOCOBALAMIN

Product NDC
0404-9783
11-digit product format
004049783
Labeler code
0404
Product ID
0404-9783_61808d2f-4f20-4d93-9d91-f6e147cb603a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CYANOCOBALAMIN
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR; SUBCUTANEOUS
Labeler
Henry Schein, Inc.
Application
ANDA209429
Marketing category
ANDA
Marketing start
2025-05-08
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
0404-9783-30CYANOCOBALAMIN30 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION302
0404-9783-30CYANOCOBALAMIN1 in 1 BAGINJECTION, SOLUTION12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0404-9783CYANOCOBALAMIN INJECTION, SOLUTION [HENRY SCHEIN, INC.]1Current NDC, 2 package rows20250524_ff32f34b-89b3-4617-ad42-2e8bcb88627e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309594cyanocobalamin 1000 MCG/ML Injectable SolutionPSNff32f34b-89b3-4617-ad42-2e8bcb88627e2
309594vitamin B12 1 MG/ML Injectable SolutionSCDff32f34b-89b3-4617-ad42-2e8bcb88627e2
309594cyanocobalamin 1 MG/ML Injectable SolutionSYff32f34b-89b3-4617-ad42-2e8bcb88627e2
309594cyanocobalamin 1000 MCG/ML Injectable SolutionSYff32f34b-89b3-4617-ad42-2e8bcb88627e2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
0404-9783-30004049783301 VIAL, MULTI-DOSE in 1 BAG (0404-9783-30) / 30 mL in 1 VIAL, MULTI-DOSE2025-05-08NoNoCurrent