FDA.reportPublic FDA data

CYANOCOBALAMIN

Product NDC
51662-1647
11-digit product format
516621647
Labeler code
51662
Product ID
51662-1647_15c4de10-c05a-8c2f-e063-6394a90a03a3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CYANOCOBALAMIN
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR; SUBCUTANEOUS
Labeler
HF Acquisition Co LLC, DBA HealthFirst
Application
ANDA080737
Marketing category
ANDA
Marketing start
1990-09-30
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
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
d206bb34-ea65-399d-70d9-834f22dc2c18Product name320170724
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51662-1647-2CYANOCOBALAMIN1 in 1 POUCHINJECTION, SOLUTION11
51662-1647-2CYANOCOBALAMIN1 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION11
51662-1647-3CYANOCOBALAMIN25 in 1 CASEINJECTION, SOLUTION251

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51662-1647CYANOCOBALAMIN INJECTION, SOLUTION [HF ACQUISITION CO LLC, DBA HEALTHFIRST]1Current NDC, 3 package rows20240412_15c4de10-c059-8c2f-e063-6394a90a03a3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309594cyanocobalamin 1000 MCG/ML Injectable SolutionPSN15c4de10-c059-8c2f-e063-6394a90a03a31
309594vitamin B12 1 MG/ML Injectable SolutionSCD15c4de10-c059-8c2f-e063-6394a90a03a31
309594cyanocobalamin 1 MG/ML Injectable SolutionSY15c4de10-c059-8c2f-e063-6394a90a03a31
309594cyanocobalamin 1000 MCG/ML Injectable SolutionSY15c4de10-c059-8c2f-e063-6394a90a03a31

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
51662-1647-2516621647021 in 1 POUCHHistorical
51662-1647-35166216470325 POUCH in 1 CASE (51662-1647-3) / 1 VIAL, MULTI-DOSE in 1 POUCH (51662-1647-2) / 1 mL in 1 VIAL, MULTI-DOSE25 pouch1990-09-30NoNoCurrent