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NDC 49483-0223-10 NITRO-TIME 9 mg/1 Details

NITRO-TIME 9 mg/1

NITRO-TIME is a ORAL CAPSULE in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by TIME CAP LABORATORIES, INC. The primary component is NITROGLYCERIN.

MedlinePlus Drug Summary

Nitroglycerin sublingual tablets are used to treat episodes of angina (chest pain) in people who have coronary artery disease (narrowing of the blood vessels that supply blood to the heart). It is also used just before activities that may cause episodes of angina in order to prevent the angina from occurring. Nitroglycerin is in a class of medications called vasodilators. It works by relaxing the blood vessels so the heart does not need to work as hard and therefore does not need as much oxygen.

Related Packages: 49483-0223-10
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Nitroglycerin Sublingual

Product Information

NDC	49483-0223
Product ID	49483-223_77d1e7a4-7b10-2f06-e053-2991aa0a2527
Associated GPIs	32100030000220
GCN Sequence Number	000457
GCN Sequence Number Description	nitroglycerin CAPSULE ER 9 MG ORAL
HIC3	A7B
HIC3 Description	VASODILATORS,CORONARY
GCN	01684
HICL Sequence Number	000159
HICL Sequence Number Description	NITROGLYCERIN
Brand/Generic	Generic
Proprietary Name	NITRO-TIME
Proprietary Name Suffix	n/a
Non-Proprietary Name	NITROGLYCERIN
Product Type	HUMAN PRESCRIPTION DRUG
Dosage Form	CAPSULE
Route	ORAL
Active Ingredient Strength	9
Active Ingredient Units	mg/1
Substance Name	NITROGLYCERIN
Labeler Name	TIME CAP LABORATORIES, INC
Pharmaceutical Class	Nitrate Vasodilator [EPC], Nitrates [CS], Vasodilation [PE]
DEA Schedule	n/a
Marketing Category	UNAPPROVED DRUG OTHER
Application Number	n/a
Listing Certified Through	2024-12-31

Package

Package Images

NDC 49483-0223-10 (49483022310)

Pricing Information	N/A
NDC Package Code	49483-223-10
Billing NDC	49483022310
Package	100 CAPSULE in 1 BOTTLE, PLASTIC (49483-223-10)
Marketing Start Date	2018-10-09
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 3c11c1c2-8e62-4f63-8293-2f8b8d845f7e Details

HOW SUPPLIED:

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

HOW 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

INGREDIENTS AND APPEARANCE

NITRO-TIME

nitroglycerin capsule

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:49483-221
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
NITROGLYCERIN (UNII: G59M7S0WS3) (NITROGLYCERIN - UNII:G59M7S0WS3)	NITROGLYCERIN	2.5 mg

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved drug other		06/19/2014

NITRO-TIME

nitroglycerin capsule

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:49483-222
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
NITROGLYCERIN (UNII: G59M7S0WS3) (NITROGLYCERIN - UNII:G59M7S0WS3)	NITROGLYCERIN	6.5 mg

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved drug other		06/19/2014

NITRO-TIME

nitroglycerin capsule

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:49483-223
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
NITROGLYCERIN (UNII: G59M7S0WS3) (NITROGLYCERIN - UNII:G59M7S0WS3)	NITROGLYCERIN	9 mg

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved drug other		06/19/2014

Labeler - TIME CAP LABORATORIES, INC (037052099)

Name	Address	ID/FEI	Business Operations
Establishment
TIME CAP LABORATORIES, INC		037052099	manufacture(49483-221, 49483-222, 49483-223)

Revised: 10/2018

Document Id: 77d1e7a4-7b10-2f06-e053-2991aa0a2527

Set id: 3c11c1c2-8e62-4f63-8293-2f8b8d845f7e

Version: 4

Effective Time: 20181009

Search by Drug Name or NDC

NDC 49483-0223-10 NITRO-TIME 9 mg/1 Details

NITRO-TIME 9 mg/1

MedlinePlus Drug Summary

Product Information

Package

Package Images

NDC 49483-0223-10 (49483022310)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL 3c11c1c2-8e62-4f63-8293-2f8b8d845f7e Details

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

INGREDIENTS AND APPEARANCE

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