DailyMed - ALBUTEROL tablet

NDC Code(s): 70771-1511-1, 70771-1512-1, 70771-1512-5
Packager: Zydus Lifesciences Limited

Category: HUMAN PRESCRIPTION DRUG LABEL
DEA Schedule: None
Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated November 25, 2024

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SPL UNCLASSIFIED SECTION

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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

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

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INGREDIENTS AND APPEARANCE

Product Information

ALBUTEROL albuterol tablet

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:70771-1511
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALBUTEROL SULFATE (UNII: 021SEF3731) (ALBUTEROL - UNII:QF8SVZ843E)	ALBUTEROL	2 mg

Ingredient Name	Strength
Inactive Ingredients
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POVIDONE K30 (UNII: U725QWY32X)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
STARCH, CORN (UNII: O8232NY3SJ)

Product Characteristics
Color	WHITE (white to off-white)	Score	2 pieces
Shape	ROUND (ROUND)	Size	6mm
Flavor		Imprint Code	10;61
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:70771-1511-1	100 in 1 BOTTLE; Type 0: Not a Combination Product	10/23/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA208884	10/23/2020

ALBUTEROL albuterol tablet

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:70771-1512
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALBUTEROL SULFATE (UNII: 021SEF3731) (ALBUTEROL - UNII:QF8SVZ843E)	ALBUTEROL	4 mg

Ingredient Name	Strength
Inactive Ingredients
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POVIDONE K30 (UNII: U725QWY32X)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
STARCH, CORN (UNII: O8232NY3SJ)

Product Characteristics
Color	WHITE (WHITE TO OFF-WHITE)	Score	2 pieces
Shape	ROUND (ROUND)	Size	9mm
Flavor		Imprint Code	10;62
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:70771-1512-1	100 in 1 BOTTLE; Type 0: Not a Combination Product	10/23/2020
2	NDC:70771-1512-5	500 in 1 BOTTLE; Type 0: Not a Combination Product	10/23/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA208884	10/23/2020

Labeler - Zydus Lifesciences Limited (918596198)

Name	Address	ID/FEI	Business Operations
Establishment
Zydus Lifesciences Limited		863362789	ANALYSIS(70771-1511, 70771-1512) , MANUFACTURE(70771-1511, 70771-1512)

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Published Date (What is this?)	Version	Files
Nov 27, 2024	4 (current)	download
Jul 3, 2024	3	download
Jul 28, 2022	2	download
Oct 27, 2020	1	download

	RxCUI	RxNorm NAME	RxTTY
1	197316	albuterol 2 MG Oral Tablet	PSN
2	197316	albuterol 2 MG Oral Tablet	SCD
3	197316	albuterol 2 MG (as albuterol sulfate 2.4 MG) Oral Tablet	SY
4	197318	albuterol 4 MG Oral Tablet	PSN
5	197318	albuterol 4 MG Oral Tablet	SCD
6	197318	albuterol 4 MG (as albuterol sulfate 4.8 MG) Oral Tablet	SY

Label: ALBUTEROL tablet

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	NDC
1	70771-1511-1
2	70771-1512-1
3	70771-1512-5

Label: ALBUTEROL tablet

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ALBUTEROL tablet

Number of versions: 4

ALBUTEROL tablet

ALBUTEROL tablet

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ALBUTEROL tablet

If this SPL contains inactivated NDCs listed by the FDA initiated compliance action, they will be specified as such.