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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

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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)

Frequently asked questions

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