FDA.reportPublic FDA data

CYANOCOBALAMIN

Product NDC
70069-171
11-digit product format
700690171
Labeler code
70069
Product ID
70069-171_510f352d-5de9-48cb-9c96-71b08f089995
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CYANOCOBALAMIN
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR; SUBCUTANEOUS
Labeler
Somerset Therapeutics, LLC
Application
ANDA209429
Marketing category
ANDA
Marketing start
2018-12-18
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
70069-171-05CYANOCOBALAMIN5 in 1 CARTONINJECTION, SOLUTION59
70069-171-05CYANOCOBALAMIN30 mL in 1 VIALINJECTION, SOLUTION309
70069-171-10CYANOCOBALAMIN10 in 1 CARTONINJECTION, SOLUTION109
70069-171-10CYANOCOBALAMIN30 mL in 1 VIALINJECTION, SOLUTION309

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70069-171-01ML - Milliliter70069-1716e16c2c6-4fc2-4722-8aa0-96693700b25b12019-03-12
70069-171-10ML - Milliliter70069-171ece85041-2431-41bc-9c4e-9b81e5a91efb12019-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70069-171CYANOCOBALAMIN INJECTION, SOLUTION [SOMERSET THERAPEUTICS, LLC]8Current NDC, Legacy NDC, 4 package rows20231219_617e44f8-df80-4764-85b9-be0fb6da8db3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309594cyanocobalamin 1000 MCG/ML Injectable SolutionPSN617e44f8-df80-4764-85b9-be0fb6da8db39
309594vitamin B12 1 MG/ML Injectable SolutionSCD617e44f8-df80-4764-85b9-be0fb6da8db39
309594cyanocobalamin 1 MG/ML Injectable SolutionSY617e44f8-df80-4764-85b9-be0fb6da8db39
309594cyanocobalamin 1000 MCG/ML Injectable SolutionSY617e44f8-df80-4764-85b9-be0fb6da8db39
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 formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70069-171-05700690171055 VIAL in 1 CARTON (70069-171-05) / 30 mL in 1 VIAL5 vial2018-12-180000-00-00NoNoCurrent
70069-171-107006901711010 VIAL in 1 CARTON (70069-171-10) / 30 mL in 1 VIAL10 vial2018-12-180000-00-00NoNoCurrent