Azelastine Hydrochloride

Product NDC
60505-0848
11-digit product format
605050848
Labeler code
60505
Product ID
60505-0848_7ee50fc2-11aa-d8f7-5ccd-52edefe1cb54
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Azelastine Hydrochloride
Dosage form
SPRAY, METERED
Route
NASAL
Labeler
Apotex Corp.
Application
ANDA201846
Marketing category
ANDA
Marketing start
2014-07-07
Marketing end
0000-00-00
Substance
AZELASTINE HYDROCHLORIDE
Active strength
206 ug/1
Pharmacologic classes
Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f4fb2f5a-dadb-40e3-a4b1-a2a58f5d9a33Product name320260126
85ee67c3-6973-4172-9ada-b124d28b42f8Product name520210528
6397aa5d-11e2-42ce-b46f-ac49599ccf00Product name520201006
033d5d5b-187f-1f40-1e5a-11d732813f92Product name420200626

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60505-0848-5ML - Milliliter60505-084805b2054c-74de-4ca9-9153-382e944560d312014-08-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1797883azelastine HCl 205.5 MCG/ACTUAT Metered Dose Nasal SprayPSNc9239ce9-f77f-0db4-e053-2995a90aa4ec1
1797883azelastine hydrochloride 0.206 MG/ACTUAT Metered Dose Nasal SpraySCDc9239ce9-f77f-0db4-e053-2995a90aa4ec1
1797883azelastine HCl 205.5 MCG/ACTUAT Metered Dose Nasal SpraySYc9239ce9-f77f-0db4-e053-2995a90aa4ec1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
60505-0848-5605050848051 BOTTLE, SPRAY in 1 CARTON (60505-0848-5) > 200 SPRAY, METERED in 1 BOTTLE, SPRAY2014-07-070000-00-00NoNoCurrent