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Nitro-Time: Package Insert / Prescribing Info

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

Medically reviewed by Drugs.com. Last updated on Mar 3, 2025.

How is Nitro-Time 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 is Nitro-Time 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

2.5 MG 100 COUNT

NITROGLYCERIN 6.5 MG 100 COUNT

6.5MG 100 COUNT

NITROGLYCERIN 9.0 MG 100 COUNT

9.0 MG 100 COUNT

NITRO-TIME
nitroglycerin capsule
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:49483-221
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NITROGLYCERIN (UNII: G59M7S0WS3) (NITROGLYCERIN - UNII:G59M7S0WS3) NITROGLYCERIN2.5 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN (UNII: O8232NY3SJ)
D&C RED NO. 28 (UNII: 767IP0Y5NH)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
ETHYLCELLULOSES (UNII: 7Z8S9VYZ4B)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GELATIN (UNII: 2G86QN327L)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SHELLAC (UNII: 46N107B71O)
SUCROSE (UNII: C151H8M554)
TALC (UNII: 7SEV7J4R1U)
WHITE WAX (UNII: 7G1J5DA97F)
Product Characteristics
Colorpink (pink) , white (clear) Scoreno score
ShapeCAPSULE (CAPSULE) Size7mm
FlavorImprint CodeTCL;1221
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49483-221-0660 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/09/2018
2NDC:49483-221-10100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/09/2018
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 DRUGItem Code (Source)NDC:49483-222
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NITROGLYCERIN (UNII: G59M7S0WS3) (NITROGLYCERIN - UNII:G59M7S0WS3) NITROGLYCERIN6.5 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN (UNII: O8232NY3SJ)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
ETHYLCELLULOSES (UNII: 7Z8S9VYZ4B)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
GELATIN (UNII: 2G86QN327L)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SHELLAC (UNII: 46N107B71O)
DIMETHICONE (UNII: 92RU3N3Y1O)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SUCROSE (UNII: C151H8M554)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
WHITE WAX (UNII: 7G1J5DA97F)
Product Characteristics
Colorblue (BLUE) , yellow (YELLOW) Scoreno score
ShapeCAPSULE (CAPSULE) Size8mm
FlavorImprint CodeTCL;1222
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49483-222-0660 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/09/2018
2NDC:49483-222-10100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/09/2018
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 DRUGItem Code (Source)NDC:49483-223
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NITROGLYCERIN (UNII: G59M7S0WS3) (NITROGLYCERIN - UNII:G59M7S0WS3) NITROGLYCERIN9 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN (UNII: O8232NY3SJ)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
ETHYLCELLULOSES (UNII: 7Z8S9VYZ4B)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
GELATIN (UNII: 2G86QN327L)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SHELLAC (UNII: 46N107B71O)
SUCROSE (UNII: C151H8M554)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
WHITE WAX (UNII: 7G1J5DA97F)
Product Characteristics
Colorgreen (GREEN) , yellow (YELLOW) Scoreno score
ShapeCAPSULE (CAPSULE) Size9mm
FlavorImprint CodeTCL;1223
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49483-223-0660 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/09/2018
2NDC:49483-223-10100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/09/2018
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)

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