Cyanocobalamin

Product NDC
55150-364
11-digit product format
551500364
Labeler code
55150
Product ID
55150-364_a0566c8d-7cb0-4ee7-8599-f2e8dc8992c7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cyanocobalamin
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR
Labeler
AuroMedics Pharma LLC
Application
ANDA213874
Marketing category
ANDA
Marketing start
2020-12-08
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
55150-364-01Cyanocobalamin1 in 1 CARTONINJECTION, SOLUTION13
55150-364-01Cyanocobalamin1 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION13
55150-364-10Cyanocobalamin1 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION13
55150-364-10Cyanocobalamin10 in 1 CARTONINJECTION, SOLUTION103
55150-364-25Cyanocobalamin1 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION13
55150-364-25Cyanocobalamin25 in 1 CARTONINJECTION, SOLUTION253

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55150-364-25ML - Milliliter55150-364af758ec8-c636-4436-b8b8-3a93b7e33aee12021-06-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55150-364CYANOCOBALAMIN INJECTION, SOLUTION [AUROMEDICS PHARMA LLC]3Current NDC, Legacy NDC, 6 package rows20220819_db84d0ea-5c15-47f5-bbe2-8d455e75695e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309594cyanocobalamin 1000 MCG/ML Injectable SolutionPSNdb84d0ea-5c15-47f5-bbe2-8d455e75695e3
309594vitamin B12 1 MG/ML Injectable SolutionSCDdb84d0ea-5c15-47f5-bbe2-8d455e75695e3
309594cyanocobalamin 1 MG/ML Injectable SolutionSYdb84d0ea-5c15-47f5-bbe2-8d455e75695e3
309594cyanocobalamin 1000 MCG/ML Injectable SolutionSYdb84d0ea-5c15-47f5-bbe2-8d455e75695e3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
55150-364-01551500364011 VIAL, MULTI-DOSE in 1 CARTON (55150-364-01) / 1 mL in 1 VIAL, MULTI-DOSE2020-12-080000-00-00NoNoCurrent
55150-364-105515003641010 VIAL, MULTI-DOSE in 1 CARTON (55150-364-10) / 1 mL in 1 VIAL, MULTI-DOSE2020-12-080000-00-00NoNoCurrent
55150-364-255515003642525 VIAL, MULTI-DOSE in 1 CARTON (55150-364-25) / 1 mL in 1 VIAL, MULTI-DOSE2020-12-080000-00-00NoNoCurrent