Nitrostat (Page 4 of 4)

PRINCIPAL DISPLAY PANEL — 0.3 mg Tablet Bottle Label

ALWAYS DISPENSE WITH
PATIENT PACKAGE INSERT

Pfizer

NDC 0071-0417-24

Nitrostat ®
(Nitroglycerin Sublingual
Tablets, USP)

0.3 mg/tablet

100 Sublingual TabletsRx only

PRINCIPAL DISPLAY PANEL -- 0.3 mg Tablet Bottle Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 0.3 mg Tablet Bottle Carton

ALWAYS DISPENSE WITH
PATIENT PACKAGE INSERT

Pfizer
NDC 0071-0417-24

Nitrostat®
(Nitroglycerin Sublingual
Tablets, USP)

0.3 mg/tablet

tablets

100 Sublingual Tablets Rx only

GTIN: 00300710417243

PRINCIPAL DISPLAY PANEL -- 0.3 mg Tablet Bottle Carton
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 0.4 mg Tablet Bottle Label

ALWAYS DISPENSE WITH
PATIENT PACKAGE INSERT

Pfizer

NDC 0071-0418-13

Nitrostat ®
(Nitroglycerin Sublingual
Tablets, USP)

0.4 mg / tablet

25 Sublingual TabletsRx only

PRINCIPAL DISPLAY PANEL -- 0.4 mg Tablet Bottle Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 0.4 mg Tablet Bottle Carton

ALWAYS DISPENSE WITH
PATIENT PACKAGE INSERT

Pfizer
NDC 0071-0418-13

Nitrostat®
(Nitroglycerin Sublingual
Tablets, USP)

0.4 mg / tablet

4 Bottles × 25 Sublingual Tablets Rx only

PRINCIPAL DISPLAY PANEL -- 0.4 mg Tablet Bottle Carton
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 0.6 mg Tablet Bottle Label

ALWAYS DISPENSE WITH
PATIENT PACKAGE INSERT

Pfizer

NDC 0071-0419-24

Nitrostat ®
(Nitroglycerin Sublingual
Tablets, USP)

0.6 mg/tablet

100 Sublingual TabletsRx only

PRINCIPAL DISPLAY PANEL -- 0.6 mg Tablet Bottle Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 0.6 mg Tablet Bottle Carton

ALWAYS DISPENSE WITH
PATIENT PACKAGE INSERT

Pfizer
NDC 0071-0419-24

Nitrostat®
(Nitroglycerin Sublingual
Tablets, USP)

0.6 mg/tablet

tablets

100 Sublingual Tablets Rx only

GTIN: 00300710419247

PRINCIPAL DISPLAY PANEL -- 0.6 mg Tablet Bottle Carton
(click image for full-size original)
NITROSTAT nitroglycerin tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0071-0417
Route of Administration SUBLINGUAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
NITROGLYCERIN (NITROGLYCERIN) NITROGLYCERIN 0.3 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE
GLYCERYL MONOSTEARATE
CALCIUM STEARATE
SILICON DIOXIDE
STARCH, CORN
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 4mm
Flavor Imprint Code N;3
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0071-0417-24 1 BOTTLE in 1 CARTON contains a BOTTLE
1 100 TABLET in 1 BOTTLE This package is contained within the CARTON (0071-0417-24)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021134 05/01/2000
NITROSTAT nitroglycerin tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0071-0418
Route of Administration SUBLINGUAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
NITROGLYCERIN (NITROGLYCERIN) NITROGLYCERIN 0.4 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE
GLYCERYL MONOSTEARATE
CALCIUM STEARATE
SILICON DIOXIDE
STARCH, CORN
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 4mm
Flavor Imprint Code N;4
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0071-0418-24 1 BOTTLE in 1 CARTON contains a BOTTLE
1 100 TABLET in 1 BOTTLE This package is contained within the CARTON (0071-0418-24)
2 NDC:0071-0418-13 4 BOTTLE in 1 CARTON contains a BOTTLE
2 25 TABLET in 1 BOTTLE This package is contained within the CARTON (0071-0418-13)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021134 05/01/2000 02/28/2025
NITROSTAT nitroglycerin tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0071-0419
Route of Administration SUBLINGUAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
NITROGLYCERIN (NITROGLYCERIN) NITROGLYCERIN 0.6 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE
GLYCERYL MONOSTEARATE
CALCIUM STEARATE
SILICON DIOXIDE
STARCH, CORN
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 4mm
Flavor Imprint Code N;6
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0071-0419-24 1 BOTTLE in 1 CARTON contains a BOTTLE
1 100 TABLET in 1 BOTTLE This package is contained within the CARTON (0071-0419-24)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021134 05/01/2000 04/30/2025
Labeler — Parke-Davis Div of Pfizer Inc (829076962)

Revised: 02/2018 Parke-Davis Div of Pfizer Inc

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