FDA.reportPublic FDA data

Children Astepro Allergy

Product NDC
0280-0066
11-digit product format
002800066
Labeler code
0280
Product ID
0280-0066_45263d0f-63fd-7187-e063-6394a90a06c0
Type
HUMAN OTC DRUG
Nonproprietary name
Azelastine HCl
Dosage form
SPRAY, METERED
Route
NASAL
Labeler
Bayer HealthCare LLC.
Application
NDA213872
Marketing category
NDA
Marketing start
2022-06-27
Substance
AZELASTINE HYDROCHLORIDE
Active strength
205.5 ug/1
Pharmacologic classes
Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Children Astepro Allergy
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AZELASTINE HYDROCHLORIDE205.5 ug/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0L591QR10I
Rxcui1797883, 1797884

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 Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0280-0066-01Children Astepro Allergy1 in 1 CARTONSPRAY, METERED17
0280-0066-01Children Astepro Allergy60 in 1 BOTTLESPRAY, METERED607
0280-0066-02Children Astepro Allergy1 in 1 CARTONSPRAY, METERED17
0280-0066-02Children Astepro Allergy120 in 1 BOTTLESPRAY, METERED1207
0280-0066-03Children Astepro Allergy1 in 1 CARTONSPRAY, METERED17
0280-0066-03Children Astepro Allergy22 in 1 BOTTLESPRAY, METERED227

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0280-0066-01ML - Milliliter0280-006664923aae-770a-4e2e-9686-8ac20798e56c12022-09-12
0280-0066-02ML - Milliliter0280-00669e7d587c-58f7-4da0-9579-ecb5a8cd55bc12022-09-12
0280-0066-03ML - Milliliter0280-0066f4bd3aa8-6472-4b52-9505-12accc2793f512023-10-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0280-0066CHILDREN ASTEPRO ALLERGY (AZELASTINE HCL) SPRAY, METERED [BAYER HEALTHCARE LLC.]6Current NDC, Legacy NDC, 6 package rows20241208_e26f9f67-4098-6d2e-e053-2995a90a8598.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1797884Astepro 205.5 MCG/ACTUAT Metered Dose Nasal SprayPSNe26f9f67-4098-6d2e-e053-2995a90a85987
1797883azelastine HCl 205.5 MCG/ACTUAT Metered Dose Nasal SprayPSNe26f9f67-4098-6d2e-e053-2995a90a85987
1797884azelastine hydrochloride 0.206 MG/ACTUAT Metered Dose Nasal Spray [Astepro]SBDe26f9f67-4098-6d2e-e053-2995a90a85987
1797883azelastine hydrochloride 0.206 MG/ACTUAT Metered Dose Nasal SpraySCDe26f9f67-4098-6d2e-e053-2995a90a85987
1797884Astepro 0.206 MG/ACTUAT Metered Dose Nasal SpraySYe26f9f67-4098-6d2e-e053-2995a90a85987
1797884Astepro 205.5 MCG/ACTUAT Metered Dose Nasal SpraySYe26f9f67-4098-6d2e-e053-2995a90a85987
1797883azelastine HCl 205.5 MCG/ACTUAT Metered Dose Nasal SpraySYe26f9f67-4098-6d2e-e053-2995a90a85987

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0280-0066-010028000660160 CARTON in 1 BOTTLE (0280-0066-01) / 1 SPRAY, METERED in 1 CARTON60 carton2022-06-300000-00-00YesNoCurrent
0280-0066-0200280006602120 CARTON in 1 BOTTLE (0280-0066-02) / 1 SPRAY, METERED in 1 CARTON120 carton2022-06-300000-00-00NoNoCurrent
0280-0066-030028000660322 CARTON in 1 BOTTLE (0280-0066-03) / 1 SPRAY, METERED in 1 CARTON22 carton2022-06-300000-00-00NoNoCurrent