FDA.reportPublic FDA data

Cyanocobalamin

Product NDC
68001-640
11-digit product format
680010640
Labeler code
68001
Product ID
68001-640_44f5a26b-5965-9a7b-e063-6294a90a682a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cyanocobalamin
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR; SUBCUTANEOUS
Labeler
BluePoint Laboratories
Application
ANDA217839
Marketing category
ANDA
Marketing start
2025-04-07
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
68001-640-59Cyanocobalamin1 mL in 1 VIALINJECTION, SOLUTION13
68001-640-60Cyanocobalamin25 in 1 CARTONINJECTION, SOLUTION253

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68001-640-59ML - Milliliter68001-64088e507df-73b0-461a-8189-78897495f61112025-03-04
68001-640-60ML - Milliliter68001-64048af21d0-37e3-49d6-b286-77b131b38cff12025-03-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68001-640CYANOCOBALAMIN INJECTION, SOLUTION [BLUEPOINT LABORATORIES]2Current NDC, 2 package rows20250523_5c603ad0-9023-44cc-955c-3988d5dcf0d3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309594cyanocobalamin 1000 MCG/ML Injectable SolutionPSN5c603ad0-9023-44cc-955c-3988d5dcf0d33
309594vitamin B12 1 MG/ML Injectable SolutionSCD5c603ad0-9023-44cc-955c-3988d5dcf0d33
309594cyanocobalamin 1 MG/ML Injectable SolutionSY5c603ad0-9023-44cc-955c-3988d5dcf0d33
309594cyanocobalamin 1000 MCG/ML Injectable SolutionSY5c603ad0-9023-44cc-955c-3988d5dcf0d33

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68001-640-59680010640591 mL in 1 VIAL1 mlHistorical
68001-640-606800106406025 VIAL in 1 CARTON (68001-640-60) / 1 mL in 1 VIAL (68001-640-59) 25 vial2025-04-07NoNoHistorical