FDA.reportPublic FDA data

Nascobal

Product NDC
49884-270
11-digit product format
498840270
Labeler code
49884
Product ID
49884-270_bd8722ab-7ac0-4e01-8244-36e8d83eca8d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
cyanocobalamin
Dosage form
SPRAY
Route
NASAL
Labeler
ENDO USA, Inc.
Application
NDA021642
Marketing category
NDA
Marketing start
2009-08-13
Marketing end
2026-12-31
Substance
CYANOCOBALAMIN
Active strength
500 ug/1
Pharmacologic classes
Vitamin B 12 [CS], Vitamin B12 [EPC]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Nascobal

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CYANOCOBALAMIN500 ug/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiP6YC3EG204
Rxcui861113, 861115

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b82b4008-22fd-05f5-6cc6-c0a6e81c65b8Product name220240805
d206bb34-ea65-399d-70d9-834f22dc2c18Product name320170724
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
49884-270-862025-02-01C16284748780-19d75b9d0-8602-f424-e053-dadaa90a57ce0a6178f6-48af-4a1d-9b35-c3c2663d0b10
49884-270-522022-10-03C16284748780-1e4f33bdf-b341-d8a0-e053-dadaa90a6e4eThese highlights do not include all the information needed to use NASCOBAL ® NASAL SPRAY safely and effectively. See full prescribing information for NASCOBAL ® NASAL SPRAY. NASCOBAL (cyanocobalamin nasal spray) Initial U.S. Approval: 1942
49884-270-822022-10-03C16284748780-1e4f33bdf-b341-d8a0-e053-dadaa90a6e4eThese highlights do not include all the information needed to use NASCOBAL ® NASAL SPRAY safely and effectively. See full prescribing information for NASCOBAL ® NASAL SPRAY. NASCOBAL (cyanocobalamin nasal spray) Initial U.S. Approval: 1942
49884-270-522022-07-29C16284748780-1e4f33bdf-b341-d8a0-e053-dadaa90a6e4eThese highlights do not include all the information needed to use NASCOBAL ® NASAL SPRAY safely and effectively. See full prescribing information for NASCOBAL ® NASAL SPRAY. NASCOBAL (cyanocobalamin nasal spray) Initial U.S. Approval: 1942
49884-270-822022-07-29C16284748780-1e4f33bdf-b341-d8a0-e053-dadaa90a6e4eThese highlights do not include all the information needed to use NASCOBAL ® NASAL SPRAY safely and effectively. See full prescribing information for NASCOBAL ® NASAL SPRAY. NASCOBAL (cyanocobalamin nasal spray) Initial U.S. Approval: 1942
49884-270-862020-01-31C16284748780-19d75b9d0-8602-f424-e053-dadaa90a57ce0a6178f6-48af-4a1d-9b35-c3c2663d0b10

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49884-270-52Nascobal1 in 1 CARTONSPRAY115
49884-270-82Nascobal4 in 1 CARTONSPRAY415

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49884-270-52EA - Each49884-2702d14da94-063d-4abe-a45c-1e149f1b8aa812014-08-01
49884-270-82EA - Each49884-270f28256b9-1569-47e4-bf88-14fc8aac531312014-09-03
49884-270-86ML - Milliliter49884-270c09ee6ea-6bb8-4a93-966f-ec8427555e0a12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CYANOCOBALAMINACTIVE INGREDIENTP6YC3EG204NASCOBAL (CYANOCOBALAMIN) SPRAY [PAR PHARMACEUTICAL , INC]3
CYANOCOBALAMINACTIVE MOIETYP6YC3EG204NASCOBAL (CYANOCOBALAMIN) SPRAY [PAR PHARMACEUTICAL , INC]3
BENZALKONIUM CHLORIDEINACTIVE INGREDIENTF5UM2KM3W7NASCOBAL (CYANOCOBALAMIN) SPRAY [PAR PHARMACEUTICAL , INC]3
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPNASCOBAL (CYANOCOBALAMIN) SPRAY [PAR PHARMACEUTICAL , INC]3
GLYCERININACTIVE INGREDIENTPDC6A3C0OXNASCOBAL (CYANOCOBALAMIN) SPRAY [PAR PHARMACEUTICAL , INC]3
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRNASCOBAL (CYANOCOBALAMIN) SPRAY [PAR PHARMACEUTICAL , INC]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49884-270NASCOBAL (CYANOCOBALAMIN) SPRAY [ENDO USA, INC.]14Current NDC, Legacy NDC, 2 package rows20240712_697e0e52-c01b-4b53-9994-f79c46eb6b4f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
861113cyanocobalamin 500 MCG/ACTUAT Nasal SprayPSN697e0e52-c01b-4b53-9994-f79c46eb6b4f15
861115NASCOBAL 500 MCG/ACTUAT Nasal SprayPSN697e0e52-c01b-4b53-9994-f79c46eb6b4f15
861115vitamin B12 0.5 MG/ACTUAT Nasal Spray [Nascobal]SBD697e0e52-c01b-4b53-9994-f79c46eb6b4f15
861113vitamin B12 0.5 MG/ACTUAT Nasal SpraySCD697e0e52-c01b-4b53-9994-f79c46eb6b4f15
861115cyanocobalamin 500 MCG per 0.1 ML Nasal Spray [Nascobal]SY697e0e52-c01b-4b53-9994-f79c46eb6b4f15
861113cyanocobalamin 500 MCG/ACTUAT Nasal SpraySY697e0e52-c01b-4b53-9994-f79c46eb6b4f15
861115Nascobal 0.5 MG/ACTUAT Nasal SpraySY697e0e52-c01b-4b53-9994-f79c46eb6b4f15
861115Nascobal 500 MCG/ACTUAT Nasal SpraySY697e0e52-c01b-4b53-9994-f79c46eb6b4f15
861113vitamin B 12 500 MCG/ACTUAT Nasal SpraySY697e0e52-c01b-4b53-9994-f79c46eb6b4f15

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49884-270-52498840270521 in 1 CARTONHistorical
49884-270-82498840270824 SPRAY in 1 CARTON (49884-270-82) 4 spray2009-08-132026-12-31NoNoCurrent