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Albuterol

ALBUTEROL TABLETS, USP Rx only

Approved
Approval ID

3f81d53d-c8b2-46f2-b6c4-dfcc18b5ae00

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Nov 19, 2019

Manufacturers
FDA

Virtus Pharmaceuticals LLC

DUNS: 079659493

Products 2

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Albuterol

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code69543-291
Application NumberANDA211397
Product Classification
M
Marketing Category
C73584
G
Generic Name
Albuterol
Product Specifications
Route of AdministrationORAL
Effective DateNovember 19, 2019
FDA Product Classification

INGREDIENTS (5)

ALBUTEROL SULFATEActive
Quantity: 4 mg in 1 1
Code: 021SEF3731
Classification: ACTIM
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT

Albuterol

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code69543-290
Application NumberANDA211397
Product Classification
M
Marketing Category
C73584
G
Generic Name
Albuterol
Product Specifications
Route of AdministrationORAL
Effective DateNovember 19, 2019
FDA Product Classification

INGREDIENTS (5)

MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
ALBUTEROL SULFATEActive
Quantity: 2 mg in 1 1
Code: 021SEF3731
Classification: ACTIM
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT

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Albuterol - FDA Drug Approval Details