FDA.reportPublic FDA data

Astepro Allergy

Product NDC
0280-0065
11-digit product format
002800065
Labeler code
0280
Product ID
0280-0065_452641af-4731-7fc3-e063-6394a90abceb
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
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
0280-0065-01Astepro Allergy1 in 1 CARTONSPRAY, METERED18
0280-0065-01Astepro Allergy60 in 1 BOTTLESPRAY, METERED608
0280-0065-02Astepro Allergy120 in 1 BOTTLESPRAY, METERED1208
0280-0065-02Astepro Allergy1 in 1 CARTONSPRAY, METERED18
0280-0065-03Astepro Allergy120 in 1 BOTTLESPRAY, METERED1208
0280-0065-03Astepro Allergy3 in 1 PACKAGESPRAY, METERED38
0280-0065-04Astepro Allergy200 in 1 BOTTLESPRAY, METERED2008
0280-0065-04Astepro Allergy1 in 1 CARTONSPRAY, METERED18
0280-0065-05Astepro Allergy1 in 1 CARTONSPRAY, METERED18
0280-0065-05Astepro Allergy22 in 1 BOTTLESPRAY, METERED228
0280-0065-09Astepro Allergy120 in 1 BOTTLESPRAY, METERED1208
0280-0065-09Astepro Allergy2 in 1 CARTONSPRAY, METERED28
0280-0065-10Astepro Allergy22 in 1 BOTTLESPRAY, METERED228
0280-0065-10Astepro Allergy1 in 1 CARTONSPRAY, METERED18

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0280-0065-01ML - Milliliter0280-0065d1fa0743-44f4-4b1f-84c0-212ce3a5f68912022-09-12
0280-0065-02ML - Milliliter0280-00657c626f3b-25e0-440d-a801-e62e6241e14212022-09-12
0280-0065-03ML - Milliliter0280-0065e7aff9a4-a389-4e26-a8ff-f06f0297f54f12025-05-14
0280-0065-04ML - Milliliter0280-006544e37908-2d50-4b03-ae9d-00862398d1d112023-10-16
0280-0065-10ML - Milliliter0280-0065de492209-5d43-4bd9-bc0f-19c96931d46912023-10-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0280-0065ASTEPRO ALLERGY (AZELASTINE HCL) SPRAY, METERED [BAYER HEALTHCARE LLC.]7Current NDC, Legacy NDC, 14 package rows20241208_e0640846-19a6-7f79-e053-2995a90a8176.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1797884Astepro 205.5 MCG/ACTUAT Metered Dose Nasal SprayPSNe0640846-19a6-7f79-e053-2995a90a81768
1797883azelastine HCl 205.5 MCG/ACTUAT Metered Dose Nasal SprayPSNe0640846-19a6-7f79-e053-2995a90a81768
1797884azelastine hydrochloride 0.206 MG/ACTUAT Metered Dose Nasal Spray [Astepro]SBDe0640846-19a6-7f79-e053-2995a90a81768
1797883azelastine hydrochloride 0.206 MG/ACTUAT Metered Dose Nasal SpraySCDe0640846-19a6-7f79-e053-2995a90a81768
1797884Astepro 0.206 MG/ACTUAT Metered Dose Nasal SpraySYe0640846-19a6-7f79-e053-2995a90a81768
1797884Astepro 205.5 MCG/ACTUAT Metered Dose Nasal SpraySYe0640846-19a6-7f79-e053-2995a90a81768
1797883azelastine HCl 205.5 MCG/ACTUAT Metered Dose Nasal SpraySYe0640846-19a6-7f79-e053-2995a90a81768

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0280-0065-010028000650160 CARTON in 1 BOTTLE (0280-0065-01) / 1 SPRAY, METERED in 1 CARTON60 carton2022-07-050000-00-00YesNoCurrent
0280-0065-0200280006502120 CARTON in 1 BOTTLE (0280-0065-02) / 1 SPRAY, METERED in 1 CARTON120 carton2022-07-050000-00-00NoNoCurrent
0280-0065-0300280006503120 PACKAGE in 1 BOTTLE (0280-0065-03) / 3 SPRAY, METERED in 1 PACKAGE120 package2022-07-050000-00-00NoNoCurrent
0280-0065-0400280006504200 CARTON in 1 BOTTLE (0280-0065-04) / 1 SPRAY, METERED in 1 CARTON200 carton2022-07-050000-00-00NoNoCurrent
0280-0065-050028000650522 CARTON in 1 BOTTLE (0280-0065-05) / 1 SPRAY, METERED in 1 CARTON22 carton2023-01-24YesNoHistorical
0280-0065-0900280006509120 CARTON in 1 BOTTLE (0280-0065-09) / 2 SPRAY, METERED in 1 CARTON120 carton2022-07-050000-00-00NoNoCurrent
0280-0065-100028000651022 CARTON in 1 BOTTLE (0280-0065-10) / 1 SPRAY, METERED in 1 CARTON22 carton2022-07-050000-00-00NoNoCurrent