cyanocobalamin

Product NDC
45802-491
11-digit product format
458020491
Labeler code
45802
Product ID
45802-491_4cf650d9-6d6c-4112-88f2-cd2e94f1f416
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
cyanocobalamin
Dosage form
SPRAY
Route
NASAL
Labeler
Padagis Israel Pharmaceuticals Ltd
Application
ANDA212458
Marketing category
ANDA
Marketing start
2023-12-28
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
45802-491-84cyanocobalamin1 in 1 BOTTLE, UNIT-DOSESPRAY14
45802-491-84cyanocobalamin4 in 1 CARTONSPRAY44

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45802-491CYANOCOBALAMIN SPRAY [PADAGIS ISRAEL PHARMACEUTICALS LTD]4Current NDC, 2 package rows20240106_971e5f30-55c2-4193-9dd8-b43a1862b92a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
861113cyanocobalamin 500 MCG/ACTUAT Nasal SprayPSN971e5f30-55c2-4193-9dd8-b43a1862b92a4
861113vitamin B12 0.5 MG/ACTUAT Nasal SpraySCD971e5f30-55c2-4193-9dd8-b43a1862b92a4
861113cyanocobalamin 500 MCG/ACTUAT Nasal SpraySY971e5f30-55c2-4193-9dd8-b43a1862b92a4
861113vitamin B 12 500 MCG/ACTUAT Nasal SpraySY971e5f30-55c2-4193-9dd8-b43a1862b92a4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
45802-491-84458020491844 BOTTLE, UNIT-DOSE in 1 CARTON (45802-491-84) / 1 SPRAY in 1 BOTTLE, UNIT-DOSE2023-12-28NoNoCurrent