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FDA Drug information

Albuterol

Read time: 1 mins
Marketing start date: 18 Apr 2025

Summary of product characteristics


Effective Time

20241125

Version

4

Spl Product Data Elements

Albuterol Albuterol ALBUTEROL SULFATE ALBUTEROL LACTOSE MONOHYDRATE MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE POVIDONE K30 SILICON DIOXIDE SODIUM STARCH GLYCOLATE TYPE A POTATO STARCH, CORN white to off-white ROUND 10;61 Albuterol Albuterol ALBUTEROL SULFATE ALBUTEROL LACTOSE MONOHYDRATE MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE POVIDONE K30 SILICON DIOXIDE SODIUM STARCH GLYCOLATE TYPE A POTATO STARCH, CORN WHITE TO OFF-WHITE ROUND 10;62

Application Number

ANDA208884

Brand Name

Albuterol

Generic Name

Albuterol

Product Ndc

70771-1512

Product Type

HUMAN PRESCRIPTION DRUG

Route

ORAL

Package Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 70771-1511-1 in bottle of 100 tablets Albuterol tablets USP, 2 mg Rx only 100 Tablets NDC 70771-1512-1 in bottle of 100 tablets Albuterol tablets USP, 4 mg Rx only 100 Tablets label label

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