NDC Code(s) : 76204-200-25, 76204-200-30, 76204-200-60, 76204-200-01
Packager : Ritedose Pharmaceuticals, LLC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Albuterol SulfateAlbuterol Sulfate SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:76204-200
Route of Administration RESPIRATORY (INHALATION) DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALBUTEROL SULFATE(UNII: 021SEF3731)
(ALBUTEROL - UNII:QF8SVZ843E) 		ALBUTEROL2.5 mg in 3 mL
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:76204-200-251 in 1 CARTON 12/05/2011
125 in 1 POUCH
13 mL in 1 AMPULE Type 0: Not a Combination Product
2NDC:76204-200-301 in 1 CARTON 12/05/2011
230 in 1 POUCH
23 mL in 1 AMPULE Type 0: Not a Combination Product
3NDC:76204-200-602 in 1 CARTON 12/05/2011
330 in 1 POUCH
33 mL in 1 AMPULE Type 0: Not a Combination Product
4NDC:76204-200-0130 in 1 CARTON 12/05/2011
41 in 1 POUCH
43 mL in 1 AMPULE Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077839 12/05/2011

LABELER - Ritedose Pharmaceuticals, LLC(968062294)

Establishment
Name Address ID/FEI Business Operations
The Ritedose Corporation 837769546 label(76204-200), manufacture(76204-200), pack(76204-200), analysis(76204-200)

PRINCIPAL DISPLAY PANEL

NDC 76204-200-25

Albuterol Sulfate
Inhalation Solution, 0.083%*

2.5 mg / 3 mL*

*Potency expressed as albuterol, equivalent to 3 mg albuterol sulfate.

Each mL contains 1 mg albuterol sulfate, equivalent to 0.83 mg albuterol
in an aqueous solution containing sodium chloride and sulfuric acid
to adjust pH between 3 and 5. Contains no preservatives.
Please consult your physician before use. Do not exceed recommended dosage.
Usual Dosage: See package insert. Protect from light.
Store between 2° and 25°C (36° and 77°F). Discard if solution becomes discolored.
(Note: Albuterol Sulfate Inhalation Solution is a clear, colorless to light yellow solution.)

Rx Only

25 x 3 mL Sterile Unit-Dose Vials

RITEDOSE PHARMACEUTICALS

25 ct brick carton

PRINCIPAL DISPLAY PANEL

NDC 76204-200-30

Albuterol Sulfate
Inhalation Solution, 0.083%*

2.5 mg / 3 mL*

*Potency expressed as albuterol, equivalent to 3 mg albuterol sulfate.

Each mL contains 1 mg albuterol sulfate, equivalent to 0.83 mg albuterol
in an aqueous solution containing sodium chloride and sulfuric acid
to adjust pH between 3 and 5. Contains no preservatives.
Please consult your physician before use. Do not exceed recommended dosage.
Usual Dosage: See package insert. Protect from light.
Store between 2° and 25°C (36° and 77°F). Discard if solution becomes discolored.
(Note: Albuterol Sulfate Inhalation Solution is a clear, colorless to light yellow solution.)

Rx Only

30 x 3 mL Sterile Unit-Dose Vials

30 ct brick carton

PRINCIPAL DISPLAY PANEL

NDC 76204-200-60

Albuterol Sulfate
Inhalation Solution, 0.083%*

2.5 mg / 3 mL*

*Potency expressed as albuterol, equivalent to 3 mg albuterol sulfate.

Each mL contains 1 mg albuterol sulfate, equivalent to 0.83 mg albuterol
in an aqueous solution containing sodium chloride and sulfuric acid
to adjust pH between 3 and 5. Contains no preservatives.
Please consult your physician before use. Do not exceed recommended dosage.
Usual Dosage: See package insert. Protect from light.
Store between 2° and 25°C (36° and 77°F). Discard if solution becomes discolored.
(Note: Albuterol Sulfate Inhalation Solution is a clear, colorless to light yellow solution.)

Rx Only

60 x 3 mL Sterile Unit-Dose Vials

60 ct brick carton

PRINCIPAL DISPLAY PANEL

NDC 76204-200-25

Albuterol Sulfate
Inhalation Solution, 0.083%*

2.5 mg / 3 mL*

*Potency expressed as albuterol, equivalent to 3 mg albuterol sulfate.

Each mL contains 1 mg albuterol sulfate, equivalent to 0.83 mg albuterol
in an aqueous solution containing sodium chloride and sulfuric acid
to adjust pH between 3 and 5. Contains no preservatives.
Please consult your physician before use. Do not exceed recommended dosage.
Usual Dosage: See package insert. Protect from light.
Store between 2° and 25°C (36° and 77°F). Discard if solution becomes discolored.
(Note: Albuterol Sulfate Inhalation Solution is a clear, colorless to light yellow solution.)

Rx Only

25 x 3 mL Sterile Unit-Dose Vials

25 ct brick sideload carton

PRINCIPAL DISPLAY PANEL

NDC 76204-200-01

Albuterol Sulfate
Inhalation Solution, 0.083%*

2.5 mg / 3 mL*

*Potency expressed as albuterol, equivalent to 3 mg albuterol sulfate.

Each mL contains 1 mg albuterol sulfate, equivalent to 0.83 mg albuterol
in an aqueous solution containing sodium chloride and sulfuric acid
to adjust pH between 3 and 5. Contains no preservatives.
Please consult your physician before use. Do not exceed recommended dosage.
Usual Dosage: See package insert. Protect from light.
Store between 2° and 25°C (36° and 77°F). Discard if solution becomes discolored.
(Note: Albuterol Sulfate Inhalation Solution is a clear, colorless to light yellow solution.)

Rx Only

30 x 3 mL Sterile Unit-Dose Vials

30 ct singles carton