NITROGLYCERIN- nitroglycerin capsule 
PD-Rx Pharmaceuticals, Inc.

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.

----------

NITROGLYCERIN 2.5 MG, 6.5 MG and 9.0 MG

HOW SUPPLIED:

2.5 mg Nitroglycerin Extended-Release (Pink and Clear Capsules imprinted TCL-1221) in bottles of 60's NDC 43063-916-60

HOW SUPPLIED

6.5 mg Nitroglycerin Extended-Release Capsules Blue/Yellow imprinted TCL1222 in bottles of 60's NDC 43063-918-60

HOW SUPPLIED

9.0 mg Nitroglycerin Extended Release Capsules Green/Yellow imprinted TCL1223 in bottles of 60's NDC 43063-919-60

NITROGLYCERIN 2.5 MG LABEL

43063916 Label

NITROGLYCERIN 6.5 MG Label

43063918 Label

NITROGLYCERIN 9.0 MG Label

43063919 Label

NITROGLYCERIN 
nitroglycerin capsule
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:43063-916(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 Code TCL;1221
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43063-916-6060 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/13/201803/11/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other06/19/201403/11/2021
NITROGLYCERIN 
nitroglycerin capsule
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:43063-918(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 Code TCL;1222
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43063-918-6060 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/13/201803/11/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other06/19/201403/11/2021
NITROGLYCERIN 
nitroglycerin capsule
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:43063-919(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 Code TCL;1223
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43063-919-6060 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/13/201803/11/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other06/19/201403/11/2021
Labeler - PD-Rx Pharmaceuticals, Inc. (156893695)
Registrant - PD-Rx Pharmaceuticals, Inc. (156893695)
Establishment
NameAddressID/FEIBusiness Operations
PD-Rx Pharmaceuticals, Inc.156893695repack(43063-918, 43063-916, 43063-919)

Revised: 3/2021
Document Id: bd474299-34e2-334b-e053-2995a90a55de
Set id: bbd659a4-b3cb-4da5-ae92-4d0761028c6c
Version: 8
Effective Time: 20210311
 
PD-Rx Pharmaceuticals, Inc.