Cyanocobalamin

Product NDC
71288-303
11-digit product format
712880303
Labeler code
71288
Product ID
71288-303_65f0f72b-691f-4cbb-a5d7-7579a133f457
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cyanocobalamin
Dosage form
INJECTION
Route
INTRAMUSCULAR; SUBCUTANEOUS
Labeler
Meitheal Pharmaceuticals Inc.
Application
ANDA214390
Marketing category
ANDA
Marketing start
2020-09-24
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
71288-303-01Cyanocobalamin1 mL in 1 VIAL, MULTI-DOSEINJECTION11
71288-303-02Cyanocobalamin25 in 1 CARTONINJECTION251
71288-303-91Cyanocobalamin1 mL in 1 VIAL, MULTI-DOSEINJECTION11
71288-303-92Cyanocobalamin25 in 1 CARTONINJECTION251

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71288-303-01ML - Milliliter71288-30393bb602e-8f2c-4224-b092-73a5b1c5e67512022-10-06
71288-303-02ML - Milliliter71288-303781330bf-6559-4a3c-ba2a-f7fa54cb06dc12022-10-06
71288-303-91ML - Milliliter71288-303120fa682-0441-45a4-b22c-1b140b23d3d112024-09-09
71288-303-92ML - Milliliter71288-303b00a1d75-7fda-447e-b43d-2ffd23158f6a12024-09-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71288-303CYANOCOBALAMIN INJECTION [MEITHEAL PHARMACEUTICALS INC.]1Current NDC, Legacy NDC, 2 package rows20240606_c6436212-9246-4e29-8540-9af992b667eb.zip
71288-303CYANOCOBALAMIN INJECTION [MEITHEAL PHARMACEUTICALS INC.]1Current NDC, Legacy NDC, 2 package rows20220517_ccf5b124-083d-4465-a666-c1bc6e84d630.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309594cyanocobalamin 1000 MCG/ML Injectable SolutionPSNc6436212-9246-4e29-8540-9af992b667eb1
309594cyanocobalamin 1000 MCG/ML Injectable SolutionPSNccf5b124-083d-4465-a666-c1bc6e84d6301
309594vitamin B12 1 MG/ML Injectable SolutionSCDc6436212-9246-4e29-8540-9af992b667eb1
309594vitamin B12 1 MG/ML Injectable SolutionSCDccf5b124-083d-4465-a666-c1bc6e84d6301
309594cyanocobalamin 1 MG/ML Injectable SolutionSYc6436212-9246-4e29-8540-9af992b667eb1
309594cyanocobalamin 1 MG/ML Injectable SolutionSYccf5b124-083d-4465-a666-c1bc6e84d6301
309594cyanocobalamin 1000 MCG/ML Injectable SolutionSYc6436212-9246-4e29-8540-9af992b667eb1
309594cyanocobalamin 1000 MCG/ML Injectable SolutionSYccf5b124-083d-4465-a666-c1bc6e84d6301

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71288-303-01712880303011 mL in 1 VIAL, MULTI-DOSE1 mlHistorical
71288-303-027128803030225 VIAL, MULTI-DOSE in 1 CARTON (71288-303-02) / 1 mL in 1 VIAL, MULTI-DOSE (71288-303-01) 2020-09-240000-00-00NoNoCurrent
71288-303-91712880303911 mL in 1 VIAL, MULTI-DOSE1 mlHistorical
71288-303-927128803039225 VIAL, MULTI-DOSE in 1 CARTON (71288-303-92) / 1 mL in 1 VIAL, MULTI-DOSE (71288-303-91) 2020-09-24NoNoHistorical