NDC 43598-412

levalbuterol inhalation

Levalbuterol Inhalation 0.31mg/3ml

levalbuterol inhalation is a Respiratory (inhalation) Solution in the Human Prescription Drug category. It is labeled and distributed by Dr. Reddy. The primary component is Levalbuterol.

• Product ID: 43598-412_13c2f13e-32da-66f4-294e-a89c3f50a206
• NDC: 43598-412
• Product Type: Human Prescription Drug
• Proprietary Name: levalbuterol inhalation
• Generic Name: Levalbuterol Inhalation 0.31mg/3ml
• Dosage Form: Solution
• Route of Administration: RESPIRATORY (INHALATION)
• Marketing Start Date: 2014-09-16
• Marketing Category: ANDA / ANDA
• Application Number: ANDA078171
• Labeler Name: Dr. Reddy
• Substance Name: LEVALBUTEROL
• Active Ingredient Strength: 0 mg/3mL
• Pharm Classes: Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 43598-412-25

5 POUCH in 1 CARTON (43598-412-25) > 5 VIAL in 1 POUCH (43598-412-05) > 3 mL in 1 VIAL

• Marketing Start Date: 2014-09-16
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 43598-412-25 [43598041225]

levalbuterol inhalation SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA078171
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2014-09-16

NDC 43598-412-05 [43598041205]

levalbuterol inhalation SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA078171
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2014-09-16

Drug Details

Active Ingredients

Ingredient	Strength
LEVALBUTEROL	.31 mg/3mL

OpenFDA Data

• SPL SET ID: 163dfa7c-aad3-4290-9fe9-d9592b0ba317
• Manufacturer:
  • Dr. Reddys Laboratories, Inc.
• UNII:
  • EDN2NBH5SS
• RxNorm Concept Unique ID - RxCUI:
  • 311286
  • 349590
  • 242754
• UPC Code:
  • 0343598410258

Pharmacological Class

• Adrenergic beta2-Agonists [MoA]
• beta2-Adrenergic Agonist [EPC]

Medicade Reported Pricing

43598041225 LEVALBUTEROL 0.31 MG/3 ML SOL

Pricing Unit: ML | Drug Type:

43598041205 LEVALBUTEROL 0.31 MG/3 ML SOL

Pricing Unit: ML | Drug Type:

NDC Crossover Matching brand name "levalbuterol inhalation" or generic name "Levalbuterol Inhalation 0.31mg/3ml"

NDC	Brand Name	Generic Name
43598-409	levalbuterol inhalation	levalbuterol inhalation 1.25mg/3mL
43598-410	levalbuterol inhalation	levalbuterol inhalation 0.63mg/3mL
43598-412	levalbuterol inhalation	levalbuterol inhalation 0.31mg/3mL