Cyanocobalamin

Product NDC
43386-237
11-digit product format
433860237
Labeler code
43386
Product ID
43386-237_bb7b94e1-b5cd-486f-9e34-38fc9595547a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cyanocobalamin
Dosage form
SPRAY, METERED
Route
NASAL
Labeler
Lupin Pharmaceuticals,Inc.
Application
ANDA210629
Marketing category
ANDA
Marketing start
2024-01-29
Substance
CYANOCOBALAMIN
Active strength
500 ug/1
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
CYANOCOBALAMIN500 ug/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiP6YC3EG204
Rxcui861113

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
43386-237-60Cyanocobalamin1 in 1 BLISTER PACKSPRAY, METERED14
43386-237-70Cyanocobalamin4 in 1 CARTONSPRAY, METERED44

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43386-237-60EA - Each43386-237df1af753-f9cd-4028-b980-47c378dc47a212024-02-14
43386-237-70EA - Each43386-2372608b657-44c4-4ce1-b67f-0ea31eb8a4dd12024-02-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43386-237CYANOCOBALAMIN SPRAY, METERED [LUPIN PHARMACEUTICALS,INC.]4Current NDC, 2 package rows20240202_efb7dc02-f0c9-4537-9e23-b641c428068c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
861113cyanocobalamin 500 MCG/ACTUAT Nasal SprayPSNefb7dc02-f0c9-4537-9e23-b641c428068c4
861113vitamin B12 0.5 MG/ACTUAT Nasal SpraySCDefb7dc02-f0c9-4537-9e23-b641c428068c4
861113cyanocobalamin 500 MCG/ACTUAT Nasal SpraySYefb7dc02-f0c9-4537-9e23-b641c428068c4
861113vitamin B 12 500 MCG/ACTUAT Nasal SpraySYefb7dc02-f0c9-4537-9e23-b641c428068c4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
43386-237-60433860237601 CARTON in 1 BLISTER PACK (43386-237-60) / 4 SPRAY, METERED in 1 CARTON (43386-237-70) 1 carton2024-01-29NoNoHistorical
43386-237-70433860237704 in 1 CARTONHistorical