Your browser does not support JavaScript! NITRO-TIME (NITROGLYCERIN) CAPSULE [TIME CAP LABORATORIES, INC]
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NITRO-TIME (nitroglycerin) capsule
[TIME CAP LABORATORIES, INC]


Category DEA Schedule Marketing Status
HUMAN PRESCRIPTION DRUG LABEL unapproved drug other
NOTE:THIS DRUG HAS NOT BEEN FOUND BY FDA TO BE SAFE AND EFFECTIVE, AND THIS LABELING HAS NOT BEEN APPROVED BY FDA. For further information about unapproved drugs, click here.
Drug Label Sections

HOW SUPPLIED:

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

PACKAGE LABEL

25LABEL

HOW SUPPLIED

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

PACKAGE LABEL

65LABEL

HOW SUPPLIED

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

PACKAGE LABEL

90LABEL

NITRO-TIME 
nitroglycerin capsule
Product Information
Product TypeHUMAN PRESCRIPTION DRUG LABELItem Code (Source)NDC:49483-221
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NITROGLYCERIN (NITROGLYCERIN) NITROGLYCERIN2.5 mg
Inactive Ingredients
Ingredient NameStrength
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
Colorpink (pink) , white (clear) Scoreno score
Shapecapsule (CAPSULE) Size7mm
FlavorImprint Code TCL;1221
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49483-221-0660 in 1 BOTTLE, PLASTIC
2NDC:49483-221-10100 in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other06/19/2014
NITRO-TIME 
nitroglycerin capsule
Product Information
Product TypeHUMAN PRESCRIPTION DRUG LABELItem Code (Source)NDC:49483-222
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NITROGLYCERIN (NITROGLYCERIN) NITROGLYCERIN6.5 mg
Inactive Ingredients
Ingredient NameStrength
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
Colorblue (BLUE) , yellow (YELLOW) Scoreno score
Shapecapsule (CAPSULE) Size8mm
FlavorImprint Code TCL;1222
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49483-222-0660 in 1 BOTTLE, PLASTIC
2NDC:49483-222-10100 in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other06/19/2014
NITRO-TIME 
nitroglycerin capsule
Product Information
Product TypeHUMAN PRESCRIPTION DRUG LABELItem Code (Source)NDC:49483-223
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NITROGLYCERIN (NITROGLYCERIN) NITROGLYCERIN9.0 mg
Inactive Ingredients
Ingredient NameStrength
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
Colorgreen (GREEN) , yellow (YELLOW) Scoreno score
Shapecapsule (CAPSULE) Size9mm
FlavorImprint Code TCL;1223
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49483-223-0660 in 1 BOTTLE, PLASTIC
2NDC:49483-223-10100 in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other06/19/2014
Labeler - TIME CAP LABORATORIES, INC (037052099)
Establishment
NameAddressID/FEIBusiness Operations
TIME CAP LABORATORIES, INC037052099manufacture(49483-221, 49483-222, 49483-223)

Revised: 6/2014
 
TIME CAP LABORATORIES, INC

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