NDC 0378-4122

Albuterol Sulfate

Albuterol Sulfate

Albuterol Sulfate is a Oral Tablet, Film Coated, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Mylan Pharmaceuticals Inc.. The primary component is Albuterol Sulfate.

• Product ID: 0378-4122_d9cf9a6d-6f4d-466d-bea2-c006d33085f8
• NDC: 0378-4122
• Product Type: Human Prescription Drug
• Proprietary Name: Albuterol Sulfate
• Generic Name: Albuterol Sulfate
• Dosage Form: Tablet, Film Coated, Extended Release
• Route of Administration: ORAL
• Marketing Start Date: 2007-01-30
• Marketing Category: ANDA / ANDA
• Application Number: ANDA078092
• Labeler Name: Mylan Pharmaceuticals Inc.
• Substance Name: ALBUTEROL SULFATE
• Active Ingredient Strength: 4 mg/1
• Pharm Classes: Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 0378-4122-01

100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-4122-01)

• Marketing Start Date: 2007-01-30
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0378-4122-01 [00378412201]

Albuterol Sulfate TABLET, FILM COATED, EXTENDED RELEASE

• Marketing Category: ANDA
• Application Number: ANDA078092
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2007-01-30

NDC 0378-4122-05 [00378412205]

Albuterol Sulfate TABLET, FILM COATED, EXTENDED RELEASE

• Marketing Category: ANDA
• Application Number: ANDA078092
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2007-01-30
• Marketing End Date: 2015-02-02

Drug Details

Active Ingredients

Ingredient	Strength
ALBUTEROL SULFATE	4 mg/1

OpenFDA Data

• SPL SET ID: 99d6ba1a-1599-48a3-8dbd-a8b06af20fe1
• Manufacturer:
  • Mylan Pharmaceuticals Inc.
• UNII:
  • 021SEF3731
• RxNorm Concept Unique ID - RxCUI:
  • 359144
  • 359145

Pharmacological Class

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

NDC Crossover Matching brand name "Albuterol Sulfate" or generic name "Albuterol Sulfate"

NDC	Brand Name	Generic Name
0054-0742	Albuterol Sulfate	Albuterol Sulfate
0093-3174	Albuterol Sulfate	Albuterol Sulfate
0254-1007	Albuterol Sulfate	Albuterol Sulfate
0378-4122	Albuterol Sulfate	albuterol sulfate
0378-4124	Albuterol Sulfate	albuterol sulfate
0378-6991	Albuterol Sulfate	albuterol sulfate
0378-6992	Albuterol Sulfate	albuterol sulfate
0378-7057	Albuterol Sulfate	Albuterol Sulfate
0378-7058	Albuterol Sulfate	Albuterol Sulfate
0378-8270	Albuterol Sulfate	Albuterol Sulfate
68071-4048	Albuterol Sulfate	Albuterol Sulfate
68071-4199	Albuterol Sulfate	Albuterol Sulfate
68071-4226	Albuterol Sulfate	Albuterol Sulfate
68071-4543	Albuterol Sulfate	Albuterol Sulfate
68071-4754	Albuterol Sulfate	Albuterol Sulfate
68084-949	albuterol sulfate	albuterol sulfate
68084-952	albuterol sulfate	albuterol sulfate
68151-0661	Albuterol Sulfate	Albuterol Sulfate
68258-8001	Albuterol Sulfate	Albuterol Sulfate
0472-0825	Albuterol Sulfate	Albuterol Sulfate
0487-9904	Albuterol Sulfate	Albuterol Sulfate
0487-9501	Albuterol Sulfate	Albuterol Sulfate
0487-9901	Albuterol Sulfate	Albuterol Sulfate
0487-0301	Albuterol Sulfate	Albuterol Sulfate
68788-0177	albuterol sulfate	albuterol sulfate
68788-0255	albuterol sulfate	albuterol sulfate
68788-0825	Albuterol Sulfate	Albuterol Sulfate
68788-0134	Albuterol Sulfate	Albuterol Sulfate
68788-7390	Albuterol Sulfate	Albuterol Sulfate
68788-9298	Albuterol Sulfate	Albuterol Sulfate
68788-9782	Albuterol Sulfate	Albuterol Sulfate
0591-3467	Albuterol Sulfate	Albuterol Sulfate
0591-3468	Albuterol Sulfate	Albuterol Sulfate
70518-1095	Albuterol Sulfate	Albuterol Sulfate
0591-3797	Albuterol Sulfate	Albuterol Sulfate
71872-7054	Albuterol Sulfate	Albuterol Sulfate
76204-200	Albuterol Sulfate	Albuterol Sulfate
0781-7155	Albuterol Sulfate	Albuterol Sulfate
17856-0740	Albuterol Sulfate	Albuterol Sulfate
21695-245	Albuterol Sulfate	Albuterol Sulfate
21695-350	Albuterol Sulfate	Albuterol Sulfate
21695-332	Albuterol Sulfate	Albuterol Sulfate
24208-347	Albuterol Sulfate	Albuterol Sulfate
33261-789	Albuterol Sulfate	Albuterol Sulfate
50090-0516	Albuterol Sulfate	Albuterol Sulfate
50383-740	Albuterol Sulfate	Albuterol Sulfate
50383-741	Albuterol Sulfate	Albuterol Sulfate
51662-1267	ALBUTEROL SULFATE	ALBUTEROL SULFATE
51662-1202	ALBUTEROL SULFATE	ALBUTEROL SULFATE
53489-177	albuterol sulfate	albuterol sulfate