Label: NITRO-TIME- nitroglycerin capsule
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NDC Code(s):
49483-221-06,
49483-221-10,
49483-222-06,
49483-222-10, view more49483-223-06, 49483-223-10
- Packager: TIME CAP LABORATORIES, INC
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
DISCLAIMER: 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 Information
Updated October 9, 2018
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- HOW SUPPLIED:
- HOW SUPPLIED
- HOW SUPPLIED
- NITROGLYCERIN 2.5 MG 100 COUNT LABEL
- NITROGLYCERIN 6.5 MG 100 COUNT
- NITROGLYCERIN 9.0 MG 100 COUNT
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INGREDIENTS AND APPEARANCE
NITRO-TIME
nitroglycerin capsuleProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49483-221 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength NITROGLYCERIN (UNII: G59M7S0WS3) (NITROGLYCERIN - UNII:G59M7S0WS3) NITROGLYCERIN 2.5 mg Inactive Ingredients Ingredient Name Strength 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 Color pink (pink) , white (clear) Score no score Shape CAPSULE (CAPSULE) Size 7mm Flavor Imprint Code TCL;1221 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49483-221-06 60 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 10/09/2018 2 NDC:49483-221-10 100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 10/09/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 06/19/2014 NITRO-TIME
nitroglycerin capsuleProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49483-222 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength NITROGLYCERIN (UNII: G59M7S0WS3) (NITROGLYCERIN - UNII:G59M7S0WS3) NITROGLYCERIN 6.5 mg Inactive Ingredients Ingredient Name Strength 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 Color blue (BLUE) , yellow (YELLOW) Score no score Shape CAPSULE (CAPSULE) Size 8mm Flavor Imprint Code TCL;1222 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49483-222-06 60 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 10/09/2018 2 NDC:49483-222-10 100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 10/09/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 06/19/2014 NITRO-TIME
nitroglycerin capsuleProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49483-223 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength NITROGLYCERIN (UNII: G59M7S0WS3) (NITROGLYCERIN - UNII:G59M7S0WS3) NITROGLYCERIN 9 mg Inactive Ingredients Ingredient Name Strength 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 Color green (GREEN) , yellow (YELLOW) Score no score Shape CAPSULE (CAPSULE) Size 9mm Flavor Imprint Code TCL;1223 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49483-223-06 60 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 10/09/2018 2 NDC:49483-223-10 100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 10/09/2018 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 Business Operations TIME CAP LABORATORIES, INC 037052099 manufacture(49483-221, 49483-222, 49483-223)