NDC 50383-738

Azelastine Hydrochloride

Azelastine Hydrochloride

Azelastine Hydrochloride is a Nasal Spray, Metered in the Human Prescription Drug category. It is labeled and distributed by Hi-tech Pharmacal Co., Inc.. The primary component is Azelastine Hydrochloride.

Product ID50383-738_45af3755-125f-436b-9123-95afe9480771
NDC50383-738
Product TypeHuman Prescription Drug
Proprietary NameAzelastine Hydrochloride
Generic NameAzelastine Hydrochloride
Dosage FormSpray, Metered
Route of AdministrationNASAL
Marketing Start Date2019-05-18
Marketing CategoryANDA / ANDA
Application NumberANDA207610
Labeler NameHi-Tech Pharmacal Co., Inc.
Substance NameAZELASTINE HYDROCHLORIDE
Active Ingredient Strength1 mg/mL
Pharm ClassesHistamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 50383-738-30

1 BOTTLE in 1 CARTON (50383-738-30) > 30 mL in 1 BOTTLE
Marketing Start Date2019-05-18
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 50383-738-30 [50383073830]

Azelastine Hydrochloride SPRAY, METERED
Marketing CategoryANDA
Application NumberANDA207610
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-05-18

Drug Details

Active Ingredients

IngredientStrength
AZELASTINE HYDROCHLORIDE1 mg/mL

OpenFDA Data

SPL SET ID:45af3755-125f-436b-9123-95afe9480771
Manufacturer
UNII

Pharmacological Class

  • Histamine H1 Receptor Antagonists [MoA]
  • Histamine-1 Receptor Antagonist [EPC]
  • Histamine H1 Receptor Antagonists [MoA]
  • Histamine-1 Receptor Antagonist [EPC]

NDC Crossover Matching brand name "Azelastine Hydrochloride" or generic name "Azelastine Hydrochloride"

NDCBrand NameGeneric Name
0054-0293Azelastine HydrochlorideAzelastine Hydrochloride
0832-0290Azelastine HydrochlorideAzelastine Hydrochloride
17478-718Azelastine HydrochlorideAzelastine Hydrochloride
42291-094Azelastine HydrochlorideAzelastine
42291-153AZELASTINE HYDROCHLORIDEAZELASTINE HYDROCHLORIDE
47335-779Azelastine HydrochlorideAzelastine Hydrochloride
47335-938Azelastine HydrochlorideAzelastine Hydrochloride
50090-2330Azelastine Hydrochlorideazelastine hydrochloride
50090-2538Azelastine HydrochlorideAzelastine Hydrochloride
50090-3833Azelastine HydrochlorideAzelastine
50383-738Azelastine HydrochlorideAzelastine Hydrochloride
50383-942Azelastine HydrochlorideAzelastine Hydrochloride
51525-0234AZELASTINE HYDROCHLORIDEazelastine hydrochloride
51525-0294Azelastine HydrochlorideAzelastine Hydrochloride
51991-814AZELASTINE HYDROCHLORIDEAZELASTINE HYDROCHLORIDE
53002-1279Azelastine Hydrochlorideazelastine hydrochloride
53002-2279Azelastine HydrochlorideAzelastine Hydrochloride
59651-214AZELASTINE HYDROCHLORIDEAZELASTINE HYDROCHLORIDE
68071-4359Azelastine HydrochlorideAzelastine Hydrochloride
68382-415AZELASTINE HYDROCHLORIDEAZELASTINE HYDROCHLORIDE
70771-1313AZELASTINE HYDROCHLORIDEAZELASTINE HYDROCHLORIDE
76519-1222AZELASTINE HYDROCHLORIDEAZELASTINE HYDROCHLORIDE
60505-0578AZELASTINE HYDROCHLORIDEAZELASTINE HYDROCHLORIDE
60505-0848Azelastine HydrochlorideAzelastine Hydrochloride
60505-0833Azelastine HydrochlorideAzelastine Hydrochloride
61314-308Azelastine HydrochlorideAzelastine Hydrochloride
65162-706Azelastine HydrochlorideAzelastine Hydrochloride
65162-676Azelastine HydrochlorideAzelastine Hydrochloride
70069-091Azelastine HydrochlorideAzelastine Hydrochloride
68083-287Azelastine HydrochlorideAzelastine Hydrochloride
71205-449Azelastine HydrochlorideAzelastine Hydrochloride
0037-0241Astelinazelastine hydrochloride
0037-0242AsteproAzelastine Hydrochloride
0037-0243AsteproAzelastine Hydrochloride
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