FDA.reportPublic FDA data

Cyanocobalamin

Product NDC
70756-637
11-digit product format
707560637
Labeler code
70756
Product ID
70756-637_088857ed-e065-4c6e-aa7e-b2bfc072c130
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cyanocobalamin
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR; SUBCUTANEOUS
Labeler
Lifestar Pharma LLC
Application
ANDA217839
Marketing category
ANDA
Marketing start
2026-05-01
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
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
48747306-602a-42cc-957b-5b0c69158eeeProduct name120180604
d206bb34-ea65-399d-70d9-834f22dc2c18Product name320170724
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70756-637-05Cyanocobalamin30 mL in 1 VIALINJECTION, SOLUTION306
70756-637-05Cyanocobalamin5 in 1 CARTONINJECTION, SOLUTION56
70756-637-10Cyanocobalamin30 mL in 1 VIALINJECTION, SOLUTION306
70756-637-10Cyanocobalamin10 in 1 CARTONINJECTION, SOLUTION106
70756-637-88Cyanocobalamin1 in 1 CARTONINJECTION, SOLUTION16
70756-637-88Cyanocobalamin30 mL in 1 VIALINJECTION, SOLUTION306

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309594cyanocobalamin 1000 MCG/ML Injectable SolutionPSNb1e35c97-2157-454e-967f-53a4300827de6
309594vitamin B12 1 MG/ML Injectable SolutionSCDb1e35c97-2157-454e-967f-53a4300827de6
309594cyanocobalamin 1 MG/ML Injectable SolutionSYb1e35c97-2157-454e-967f-53a4300827de6
309594cyanocobalamin 1000 MCG/ML Injectable SolutionSYb1e35c97-2157-454e-967f-53a4300827de6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70756-637-05707560637055 VIAL in 1 CARTON (70756-637-05) / 30 mL in 1 VIAL5 vial2026-05-01NoNoHistorical
70756-637-107075606371010 VIAL in 1 CARTON (70756-637-10) / 30 mL in 1 VIAL10 vial2026-05-01NoNoHistorical
70756-637-88707560637881 VIAL in 1 CARTON (70756-637-88) / 30 mL in 1 VIAL1 vial2026-05-01NoNoHistorical