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Albuterol Sulfate

ALBUTEROL TABLETS USP

Approved
Approval ID

b0f73459-baeb-42a7-be48-2c3647d9b205

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Oct 4, 2022

Manufacturers
FDA

American Health Packaging

DUNS: 929561009

Products 2

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

Albuterol Sulfate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code68084-949
Application NumberANDA072637
Product Classification
M
Marketing Category
C73584
G
Generic Name
Albuterol Sulfate
Product Specifications
Route of AdministrationORAL
Effective DateOctober 4, 2022
FDA Product Classification

INGREDIENTS (5)

MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
ALBUTEROL SULFATEActive
Quantity: 2 mg in 1 1
Code: 021SEF3731
Classification: ACTIM

albuterol sulfate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code68084-952
Application NumberANDA072637
Product Classification
M
Marketing Category
C73584
G
Generic Name
albuterol sulfate
Product Specifications
Route of AdministrationORAL
Effective DateOctober 4, 2022
FDA Product Classification

INGREDIENTS (5)

ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
ALBUTEROL SULFATEActive
Quantity: 4 mg in 1 1
Code: 021SEF3731
Classification: ACTIM

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Albuterol Sulfate - FDA Drug Approval Details