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Nitro-Time

Package insert / prescribing information
Generic name: nitroglycerin
Dosage form: extended-release capsules
Drug classes: Antianginal agents, Vasodilators

Medically reviewed by Drugs.com. Last updated on Sep 21, 2022.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. Read further information about unapproved drugs.

HOW SUPPLIED:

2.5 mg Nitroglycerin Extended-Release (Pink and Clear Capsules imprinted TCL-1221) in bottles of 60's & 100's

How is Nitro-Time Supplied

6.5 mg Nitroglycerin Extended-Release Capsules Blue/Yellow imprinted TCL1222 in bottles of 60's and 100's

HOW SUPPLIED

9.0 mg Nitroglycerin Extended Release Capsules Green/Yellow imprinted TCL1223 in bottles of 60's and 100's

NITROGLYCERIN 2.5 MG 100 COUNT LABEL

NITROGLYCERIN 6.5 MG 100 COUNT

NITROGLYCERIN 9.0 MG 100 COUNT

Nitro-Time
nitroglycerin capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49483-221
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
NITROGLYCERIN (NITROGLYCERIN) NITROGLYCERIN 2.5 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN
D&C RED NO. 28
D&C YELLOW NO. 10
ETHYLCELLULOSES
FD&C BLUE NO. 1
FD&C BLUE NO. 2
FD&C RED NO. 40
GELATIN
FERROSOFERRIC OXIDE
LACTOSE MONOHYDRATE
PROPYLENE GLYCOL
SHELLAC
SUCROSE
TALC
WHITE WAX
Product Characteristics
Color pink (pink) , white (clear) Score no score
Shape CAPSULE (CAPSULE) Size 7mm
Flavor Imprint Code TCL;1221
Contains
Packaging
# Item Code Package Description
1 NDC:49483-221-06 60 CAPSULE in 1 BOTTLE, PLASTIC
2 NDC:49483-221-10 100 CAPSULE in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 06/19/2014
Nitro-Time
nitroglycerin capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49483-222
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
NITROGLYCERIN (NITROGLYCERIN) NITROGLYCERIN 6.5 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN
D&C RED NO. 33
D&C YELLOW NO. 10
ETHYLCELLULOSES
FD&C BLUE NO. 1
FD&C YELLOW NO. 6
GELATIN
LACTOSE MONOHYDRATE
PROPYLENE GLYCOL
SHELLAC
DIMETHICONE
SILICON DIOXIDE
SUCROSE
TALC
TITANIUM DIOXIDE
WHITE WAX
Product Characteristics
Color blue (BLUE) , yellow (YELLOW) Score no score
Shape CAPSULE (CAPSULE) Size 8mm
Flavor Imprint Code TCL;1222
Contains
Packaging
# Item Code Package Description
1 NDC:49483-222-06 60 CAPSULE in 1 BOTTLE, PLASTIC
2 NDC:49483-222-10 100 CAPSULE in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 06/19/2014
Nitro-Time
nitroglycerin capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49483-223
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
NITROGLYCERIN (NITROGLYCERIN) NITROGLYCERIN 9 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN
D&C YELLOW NO. 10
ETHYLCELLULOSES
FD&C BLUE NO. 1
FD&C BLUE NO. 2
FD&C GREEN NO. 3
FD&C RED NO. 40
FD&C YELLOW NO. 6
GELATIN
FERROSOFERRIC OXIDE
LACTOSE MONOHYDRATE
PROPYLENE GLYCOL
SHELLAC
SUCROSE
TALC
TITANIUM DIOXIDE
WHITE WAX
Product Characteristics
Color green (GREEN) , yellow (YELLOW) Score no score
Shape CAPSULE (CAPSULE) Size 9mm
Flavor Imprint Code TCL;1223
Contains
Packaging
# Item Code Package Description
1 NDC:49483-223-06 60 CAPSULE in 1 BOTTLE, PLASTIC
2 NDC:49483-223-10 100 CAPSULE in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 06/19/2014
Labeler - TIME CAP LABORATORIES, INC (037052099)
Establishment
Name Address ID/FEI Operations
TIME CAP LABORATORIES, INC 037052099 manufacture(49483-221, 49483-222, 49483-223)
TIME CAP LABORATORIES, INC

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