MODEL 2004FAA MODEL 3-EEMK MODEL 3-EEMK-1 MODEL AA-8565 MODEL AA-8565-LATAM MODEL AWFAREMK MODEL CHAUTAUQUAEMK MODEL EMK1000-10 MODEL FAREMK MODEL PMONTFAREMK MODEL SWEEMK MODEL SWEEMK-1 MODEL QXEMK MODEL G4FAREMK MODEL AA-8565 (EXCLUDING MIAMI AIR)- kit

Model 2004FAA Model 3-EEMK Model 3-EEMK-1 Model AA-8565 Model AA-8565-LATAM Model AWFAREMK Model CHAUTAUQUAEMK Model emk1000-10 Model FAREMK Model PMONTFAREMK Model SWEEMK Model SWEEMK-1 Model QXEMK Model G4FAREMK Model AA-8565 (excluding Miami Air) by

Drug Labeling and Warnings

Model 2004FAA Model 3-EEMK Model 3-EEMK-1 Model AA-8565 Model AA-8565-LATAM Model AWFAREMK Model CHAUTAUQUAEMK Model emk1000-10 Model FAREMK Model PMONTFAREMK Model SWEEMK Model SWEEMK-1 Model QXEMK Model G4FAREMK Model AA-8565 (excluding Miami Air) by is a Other medication manufactured, distributed, or labeled by Aerospace Accessory Service, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Aerospace Accessory Service

Aerospace Accessory Service

P/N:

S/N:

EXP:

Prep. By: 

INGREDIENTS AND APPEARANCE

MODEL 2004FAA MODEL 3-EEMK MODEL 3-EEMK-1 MODEL AA-8565 MODEL AA-8565-LATAM MODEL AWFAREMK MODEL CHAUTAUQUAEMK MODEL EMK1000-10 MODEL FAREMK MODEL PMONTFAREMK MODEL SWEEMK MODEL SWEEMK-1 MODEL QXEMK MODEL G4FAREMK MODEL AA-8565 (EXCLUDING MIAMI AIR) 
emergency response safety kit kit

Product Information
Product Type	MEDICAL DEVICE	Item Code (Source)	NHRIC:27860-001

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NHRIC:27860-001-13	1 in 1 PACKAGE; Type 1: Convenience Kit of Co-Package

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1		1
Part 2		1
Part 3		1
Part 4		1
Part 5		1
Part 6		1
Part 7		1
Part 8		1
Part 9		1
Part 10		1
Part 11		1
Part 12		1
Part 13		1
Part 14		1
Part 15		1
Part 16		1
Part 17		1
Part 18		1
Part 19		1
Part 20		1
Part 21		1
Part 22		1
Part 23		1
Part 24		1
Part 25		1
Part 26		1
Part 27		1

Part 1 of 27

SODIUM CHLORIDE 
sodium chloride injection, solution

Product Information
Item Code (Source)	NDC: 0338-0049
Route of Administration	INTRAVENOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698, SODIUM CATION - UNII:LYR4M0NH37)	SODIUM CHLORIDE	9 g  in 1000 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA016677	12/09/1970

Part 2 of 27

SODIUM CHLORIDE 
sodium chloride injection, solution

Product Information
Item Code (Source)	NDC: 0264-7800
Route of Administration	INTRAVENOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698, SODIUM CATION - UNII:LYR4M0NH37)	SODIUM CHLORIDE	0.9 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA019635	03/09/1988

Part 3 of 27

ATROPINE SULFATE 
atropine sulfate injection, solution

Product Information
Item Code (Source)	NDC: 0409-4910
Route of Administration	INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS, ENDOTRACHEAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ATROPINE SULFATE (UNII: 03J5ZE7KA5) (ATROPINE - UNII:7C0697DR9I)	ATROPINE SULFATE	0.1 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
SULFURIC ACID (UNII: O40UQP6WCF)
WATER (UNII: 059QF0KO0R)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA021146	01/19/2006

Part 4 of 27

ATROPINE SULFATE 
atropine sulfate injection

Product Information
Item Code (Source)	NDC: 76329-3339
Route of Administration	PARENTERAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Atropine Sulfate (UNII: 03J5ZE7KA5) (ATROPINE - UNII:7C0697DR9I)	Atropine Sulfate	0.1 mg  in 1 mL

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		06/01/2000

Part 5 of 27

EPINEPHRINE 
epinephrine injection

Product Information
Item Code (Source)	NDC: 76329-3316
Route of Administration	INTRAVENOUS, INTRACARDIAC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Epinephrine (UNII: YKH834O4BH) (EPINEPHRINE - UNII:YKH834O4BH)	Epinephrine	0.1 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Sodium Bisulfite (UNII: TZX5469Z6I)
Sodium Chloride (UNII: 451W47IQ8X)
Hydrochloric Acid (UNII: QTT17582CB)
Sodium Citrate (UNII: 1Q73Q2JULR)
Citric Acid Monohydrate (UNII: 2968PHW8QP)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		12/01/1976

Part 6 of 27

EPINEPHRINE 
epinephrine injection, solution

Product Information
Item Code (Source)	NDC: 0409-4933
Route of Administration	INTRAVENOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Epinephrine (UNII: YKH834O4BH) (EPINEPHRINE - UNII:YKH834O4BH)	Epinephrine	0.1 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Sodium Chloride (UNII: 451W47IQ8X)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA209359	03/10/2021

Part 7 of 27

EPINEPHRINE 
epinephrine injection, solution

Product Information
Item Code (Source)	NDC: 0409-4921
Route of Administration	INTRAVENOUS, INTRACARDIAC, ENDOTRACHEAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
EPINEPHRINE (UNII: YKH834O4BH) (EPINEPHRINE - UNII:YKH834O4BH)	EPINEPHRINE	0.1 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		09/14/2005	01/01/2017

Part 8 of 27

LIDOCAINE HYDROCHLORIDE 
lidocaine hydrochloride injection, solution

Product Information
Item Code (Source)	NDC: 0409-1323
Route of Administration	INTRAVENOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE ANHYDROUS	20 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
SODIUM HYDROXIDE (UNII: 55X04QC32I)
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM CHLORIDE (UNII: 451W47IQ8X)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA040302	12/09/2005

Part 9 of 27

LIDOCAINE 
lidocaine hydrochloride injection, solution

Product Information
Item Code (Source)	NDC: 63323-208
Route of Administration	INTRAVENOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE ANHYDROUS	20 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
SODIUM CHLORIDE (UNII: 451W47IQ8X)
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA017584	09/05/2000

Part 10 of 27

LIDOCAINE HYDROCHLORIDE 
lidocaine hydrochloride injection

Product Information
Item Code (Source)	NDC: 76329-3390
Route of Administration	INTRAVENOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE ANHYDROUS	20 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA083173	06/01/2001

Part 11 of 27

DEXTROSE MONOHYDRATE 
dextrose monohydrate injection

Product Information
Item Code (Source)	NDC: 76329-3301
Route of Administration	PARENTERAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTROSE MONOHYDRATE (UNII: LX22YL083G) (ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK)	DEXTROSE MONOHYDRATE	500 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		06/01/2000

Part 12 of 27

DEXTROSE 
dextrose monohydrate injection, solution

Product Information
Item Code (Source)	NDC: 0409-6648
Route of Administration	INTRAVENOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTROSE MONOHYDRATE (UNII: LX22YL083G) (ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK)	DEXTROSE MONOHYDRATE	25 g  in 50 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
HYDROCHLORIC ACID (UNII: QTT17582CB)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA019445	12/02/2005

Part 13 of 27

NITROGLYCERIN 
nitroglycerin tablet

Product Information
Item Code (Source)	NDC: 68462-639
Route of Administration	SUBLINGUAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
NITROGLYCERIN (UNII: G59M7S0WS3) (NITROGLYCERIN - UNII:G59M7S0WS3)	NITROGLYCERIN	0.4 mg

Inactive Ingredients
Ingredient Name	Strength
CALCIUM STEARATE (UNII: 776XM7047L)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)

Product Characteristics
Color	white (white to off white)	Score	no score
Shape	ROUND (Flat faced)	Size	4mm
Flavor		Imprint Code	2;C
Contains

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA206391	08/19/2017

Part 14 of 27

DIPHENHYDRAMINE HYDROCHLORIDE 
diphenhydramine hydrochloride injection

Product Information
Item Code (Source)	NDC: 0641-0376
Route of Administration	INTRAMUSCULAR, INTRAVENOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	50 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
BENZETHONIUM CHLORIDE (UNII: PH41D05744)
WATER (UNII: 059QF0KO0R)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
HYDROCHLORIC ACID (UNII: QTT17582CB)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA080817	11/27/1972

Part 15 of 27

EPINEPHRINE 
epinephrine injection, solution, concentrate

Product Information
Item Code (Source)	NDC: 54288-103
Route of Administration	INTRAVENOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Epinephrine (UNII: YKH834O4BH) (EPINEPHRINE - UNII:YKH834O4BH)	Epinephrine	1 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Sodium Chloride (UNII: 451W47IQ8X)
Hydrochloric Acid (UNII: QTT17582CB)
Water (UNII: 059QF0KO0R)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA205029	08/08/2014

Part 16 of 27

EASY CARE FIRST AID DIPHENHYDRAMINE 
diphenhydramine hydrochloride tablet, film coated

Product Information
Item Code (Source)	NDC: 4422-0017
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	25 mg

Inactive Ingredients
Ingredient Name	Strength
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
D&C RED NO. 27 (UNII: 2LRS185U6K)
HYPROMELLOSES (UNII: 3NXW29V3WO)
LACTOSE (UNII: J2B2A4N98G)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	pink (pink)	Score	no score
Shape	OVAL (OVAL)	Size	11mm
Flavor		Imprint Code	048;D
Contains

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	01/01/2012

Part 17 of 27

ALCOHOL PREP 
isopropyl alcohol swab

Product Information
Item Code (Source)	NDC: 67777-121
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302)	ISOPROPYL ALCOHOL	0.7 mL  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	07/01/2010

Part 18 of 27

MOORE MEDICAL NON ASPIRIN 
acetaminophen tablet, film coated

Product Information
Item Code (Source)	NDC: 55670-467
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	325 mg

Inactive Ingredients
Ingredient Name	Strength
HYPROMELLOSES (UNII: 3NXW29V3WO)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
STARCH, CORN (UNII: O8232NY3SJ)
STEARIC ACID (UNII: 4ELV7Z65AP)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	white (white)	Score	no score
Shape	ROUND (ROUND)	Size	10mm
Flavor		Imprint Code	AZ;234
Contains

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part343	12/30/2008

Part 19 of 27

ASPIRIN 
aspirin tablet, film coated

Product Information
Item Code (Source)	NDC: 55670-131
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E)	ASPIRIN	325 mg

Inactive Ingredients
Ingredient Name	Strength
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
HYPROMELLOSES (UNII: 3NXW29V3WO)
MINERAL OIL (UNII: T5L8T28FGP)
STARCH, CORN (UNII: O8232NY3SJ)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	white (white)	Score	no score
Shape	ROUND (ROUND)	Size	10mm
Flavor		Imprint Code	TCL;011
Contains

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part343	12/30/2008	08/31/2022

Part 20 of 27

MOOREBRAND ASPIRIN 
aspirin tablet, film coated

Product Information
Item Code (Source)	NDC: 55670-616(NDC:50844-957)
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E)	ASPIRIN	325 mg

Inactive Ingredients
Ingredient Name	Strength
STARCH, CORN (UNII: O8232NY3SJ)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)

Product Characteristics
Color	white	Score	no score
Shape	ROUND	Size	10mm
Flavor		Imprint Code	Aspirin;44;157
Contains

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part343	10/05/2020

Part 21 of 27

VENTOLIN  HFA
albuterol sulfate aerosol, metered

Product Information
Item Code (Source)	NDC: 0173-0682
Route of Administration	RESPIRATORY (INHALATION)

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALBUTEROL SULFATE (UNII: 021SEF3731) (ALBUTEROL - UNII:QF8SVZ843E)	ALBUTEROL	90 ug

Inactive Ingredients
Ingredient Name	Strength
NORFLURANE (UNII: DH9E53K1Y8)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA020983	06/09/2006

Part 22 of 27

ALBUTEROL SULFATE  HFA
albuterol sulfate aerosol, metered

Product Information
Item Code (Source)	NDC: 66993-019
Route of Administration	RESPIRATORY (INHALATION)

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALBUTEROL SULFATE (UNII: 021SEF3731) (ALBUTEROL - UNII:QF8SVZ843E)	ALBUTEROL	90 ug

Inactive Ingredients
Ingredient Name	Strength
NORFLURANE (UNII: DH9E53K1Y8)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA authorized generic	NDA020983	01/15/2019

Part 23 of 27

ALBUTEROL SULFATE 
albuterol sulfate aerosol, metered

Product Information
Item Code (Source)	NDC: 45802-088
Route of Administration	RESPIRATORY (INHALATION)

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALBUTEROL SULFATE (UNII: 021SEF3731) (ALBUTEROL - UNII:QF8SVZ843E)	ALBUTEROL	90 ug

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)
NORFLURANE (UNII: DH9E53K1Y8)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA203760	02/26/2020

Part 24 of 27

ALBUTEROL SULFATE  HFA
albuterol sulfate aerosol, metered

Product Information
Item Code (Source)	NDC: 0093-3174
Route of Administration	RESPIRATORY (INHALATION)

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALBUTEROL SULFATE (UNII: 021SEF3731) (ALBUTEROL - UNII:QF8SVZ843E)	ALBUTEROL	90 ug

Inactive Ingredients
Ingredient Name	Strength
NORFLURANE (UNII: DH9E53K1Y8)
ALCOHOL (UNII: 3K9958V90M)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA021457	01/16/2019

Part 25 of 27

ALBUTEROL SULFATE 
albuterol sulfate inhalant

Product Information
Item Code (Source)	NDC: 69097-142
Route of Administration	RESPIRATORY (INHALATION)

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALBUTEROL SULFATE (UNII: 021SEF3731) (ALBUTEROL - UNII:QF8SVZ843E)	ALBUTEROL	108 ug

Inactive Ingredients
Ingredient Name	Strength
OLEIC ACID (UNII: 2UMI9U37CP)
NORFLURANE (UNII: DH9E53K1Y8)
ALCOHOL (UNII: 3K9958V90M)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA209959	04/08/2020

Part 26 of 27

ALBUTEROL SULFATE 
albuterol sulfate aerosol, metered

Product Information
Item Code (Source)	NDC: 0254-1007
Route of Administration	RESPIRATORY (INHALATION)

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALBUTEROL SULFATE (UNII: 021SEF3731) (ALBUTEROL - UNII:QF8SVZ843E)	ALBUTEROL	108 ug

Inactive Ingredients
Ingredient Name	Strength
OLEIC ACID (UNII: 2UMI9U37CP)
NORFLURANE (UNII: DH9E53K1Y8)
ALCOHOL (UNII: 3K9958V90M)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA authorized generic	NDA020503	04/03/2019

Part 27 of 27

PROAIR  HFA
albuterol sulfate aerosol, metered

Product Information
Item Code (Source)	NDC: 59310-579
Route of Administration	RESPIRATORY (INHALATION)

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALBUTEROL SULFATE (UNII: 021SEF3731) (ALBUTEROL - UNII:QF8SVZ843E)	ALBUTEROL	90 ug

Inactive Ingredients
Ingredient Name	Strength
NORFLURANE (UNII: DH9E53K1Y8)
ALCOHOL (UNII: 3K9958V90M)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA021457	12/03/2012

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
exempt device	ABC	01/01/2015

Labeler - Aerospace Accessory Service, Inc (859100547)

Registrant - Aerospace Accessory Service, Inc (859100547)

Establishment
Name	Address	ID/FEI	Business Operations
Aerospace Accessory Service, Inc		859100547	manufacture, repack