NDC 35781-0194

TRANZGEL

Echinacea Angustifolia, Echinacea Purpurea, Aconitum Napellus, Arnica Montana, Calendula Officianalis, Hamamelis Virginiana, Belladonna, Bellis Perennis, Chamomillia, Millefolium, Hypericum Perforatum

TRANZGEL is a Transdermal Gel in the Human Prescription Drug category. It is labeled and distributed by Gensco Laboratories, Llc. The primary component is Echinacea Angustifolia; Echinacea Purpurea; Aconitum Napellus; Arnica Montana; Calendula Officinalis Flowering Top; Hamamelis Virginiana Root Bark/stem Bark; Atropa Belladonna; Bellis Perennis; Chamomile; Achillea Millefolium; Hypericum Oil; Comfrey Root; Colchicine.

• Product ID: 35781-0194_9135b37f-d8f4-44ae-a7b3-677a1c83ee84
• NDC: 35781-0194
• Product Type: Human Prescription Drug
• Proprietary Name: TRANZGEL
• Generic Name: Echinacea Angustifolia, Echinacea Purpurea, Aconitum Napellus, Arnica Montana, Calendula Officianalis, Hamamelis Virginiana, Belladonna, Bellis Perennis, Chamomillia, Millefolium, Hypericum Perforatum
• Dosage Form: Gel
• Route of Administration: TRANSDERMAL
• Marketing Start Date: 2010-07-01
• Marketing Category: UNAPPROVED HOMEOPATHIC / UNAPPROVED HOMEOPATHIC
• Labeler Name: Gensco Laboratories, LLC
• Substance Name: ECHINACEA ANGUSTIFOLIA; ECHINACEA PURPUREA; ACONITUM NAPELLUS; ARNICA MONTANA; CALENDULA OFFICINALIS FLOWERING TOP; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; ATROPA BELLADONNA; BELLIS PERENNIS; CHAMOMILE; ACHILLEA MILLEFOLIUM; HYPERICUM OIL; COMFREY ROOT; COLCHICINE
• Active Ingredient Strength: 1 [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL; [hp_X]/50mL
• Pharm Classes: Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Interactions [MoA]
• NDC Exclude Flag: E
• Listing Certified Through: 2018-12-31

Packaging

NDC 35781-0194-5

1 BOTTLE, DISPENSING in 1 CARTON (35781-0194-5) > 50 mL in 1 BOTTLE, DISPENSING

• Marketing Start Date: 2010-07-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 35781-0194-5 [35781019405]

TRANZGEL GEL

• Marketing Category: unapproved homeopathic
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2010-07-01
• Inactivation Date: 2020-01-31

Drug Details

Active Ingredients

Ingredient	Strength
ECHINACEA ANGUSTIFOLIA	1 [hp_X]/50mL

OpenFDA Data

• SPL SET ID: abc4b131-4d35-46a4-9a8e-9bd4c7a0f4b0
• Manufacturer:
  • Gensco Laboratories, LLC
• UNII:
  • QI7G114Y98
  • M9VVZ08EKQ
  • OZU2FC70HY
  • O80TY208ZW
  • FGL3685T2X
  • WQZ3G9PF0H
  • 2HU33I03UY
  • 18E7415PXQ
  • SML2Y3J35T
  • 2FXJ6SW4PK
  • T7S323PKJS
  • VB06AV5US8
  • U0NQ8555JD

Pharmacological Class

• Cytochrome P450 3A4 Inhibitors [MoA]
• P-Glycoprotein Interactions [MoA]

NDC Crossover Matching brand name "TRANZGEL" or generic name "Echinacea Angustifolia, Echinacea Purpurea, Aconitum Napellus, Arnica Montana, Calendula Officianalis, Hamamelis Virginiana, Belladonna, Bellis Perennis, Chamomillia, Millefolium, Hypericum Perforatum"

NDC	Brand Name	Generic Name
35781-0194	TRANZGEL	ECHINACEA ANGUSTIFOLIA, ECHINACEA PURPUREA, ACONITUM NAPELLUS, ARNICA MONTANA, CALENDULA OFFICIANALIS, HAMAMELIS VIRGINIANA, BELLADONNA, BELLIS PERENNIS, CHAMOMILLIA, MILLEFOLIUM, HYPERICUM PERFORATUM
50436-9071	TRANZGEL	ECHINACEA ANGUSTIFOLIA, ECHINACEA PURPUREA, ACONITUM NAPELLUS, ARNICA MONTANA, CALENDULA OFFICIANALIS, HAMAMELIS VIRGINIANA, BELLADONNA, BELLIS PERENNIS, CHAMOMILLIA, MILLEFOLIUM, HYPERICUM PERFORATUM, SYMPHYTUM OFFICINALE, COLCHICINUM