NDC 68788-6777

Levalbuterol

Levalbuterol

Levalbuterol is a Respiratory (inhalation) Solution in the Human Prescription Drug category. It is labeled and distributed by Preferred Pharmaceuticals, Inc.. The primary component is Levalbuterol Hydrochloride.

• Product ID: 68788-6777_6ff571b0-cca5-4aef-bf29-95d2231e81d2
• NDC: 68788-6777
• Product Type: Human Prescription Drug
• Proprietary Name: Levalbuterol
• Generic Name: Levalbuterol
• Dosage Form: Solution
• Route of Administration: RESPIRATORY (INHALATION)
• Marketing Start Date: 2016-10-24
• Marketing Category: ANDA / ANDA
• Application Number: ANDA090297
• Labeler Name: Preferred Pharmaceuticals, Inc.
• Substance Name: LEVALBUTEROL HYDROCHLORIDE
• Active Ingredient Strength: 1 mg/3mL
• Pharm Classes: Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 68788-6777-2

6 POUCH in 1 CARTON (68788-6777-2) > 4 VIAL, SINGLE-DOSE in 1 POUCH > 3 mL in 1 VIAL, SINGLE-DOSE

• Marketing Start Date: 2016-10-24
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 68788-6777-2 [68788677702]

Levalbuterol SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA090297
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2016-10-24

Drug Details

Active Ingredients

Ingredient	Strength
LEVALBUTEROL HYDROCHLORIDE	.63 mg/3mL

OpenFDA Data

• SPL SET ID: 65d1d052-bf17-4fbe-94d0-3fba98c7163a
• Manufacturer:
  • Preferred Pharmaceuticals, Inc.
• UNII:
  • WDQ1526QJM
• RxNorm Concept Unique ID - RxCUI:
  • 311286

Pharmacological Class

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

NDC Crossover Matching brand name "Levalbuterol" or generic name "Levalbuterol"

NDC	Brand Name	Generic Name
0093-4145	Levalbuterol	Levalbuterol
0093-4146	Levalbuterol	Levalbuterol
0093-4147	Levalbuterol	Levalbuterol
0093-4148	Levalbuterol	Levalbuterol
0115-9930	Levalbuterol	Levalbuterol Hydrochloride
0115-9931	Levalbuterol	Levalbuterol Hydrochloride
0115-9932	Levalbuterol	Levalbuterol Hydrochloride
0378-6993	Levalbuterol	levalbuterol
0378-9680	Levalbuterol	levalbuterol
0378-9681	Levalbuterol	levalbuterol
0378-9682	Levalbuterol	levalbuterol
0378-9690	Levalbuterol	Levalbuterol
0378-9691	Levalbuterol	Levalbuterol
0378-9692	Levalbuterol	Levalbuterol
35573-443	Levalbuterol	Levalbuterol Hydrochloride
35573-444	Levalbuterol	Levalbuterol Hydrochloride
35573-445	Levalbuterol	Levalbuterol Hydrochloride
63187-953	Levalbuterol	Levalbuterol
65862-942	LEVALBUTEROL	LEVALBUTEROL
65862-943	Levalbuterol	Levalbuterol
65862-944	Levalbuterol	Levalbuterol
65862-945	Levalbuterol	Levalbuterol
68788-6777	Levalbuterol	Levalbuterol
76204-900	Levalbuterol	Levalbuterol
76204-800	Levalbuterol	Levalbuterol
76204-700	Levalbuterol	Levalbuterol
68071-5027	Levalbuterol	Levalbuterol
68071-2340	Levalbuterol	Levalbuterol