NDC 61919-542

GAVILAX

Gavilax

GAVILAX is a Oral Powder, For Solution in the Human Prescription Drug category. It is labeled and distributed by Directrx. The primary component is Polyethylene Glycol 3350.

• Product ID: 61919-542_267d6042-f4cc-4d5c-e054-00144ff8d46c
• NDC: 61919-542
• Product Type: Human Prescription Drug
• Proprietary Name: GAVILAX
• Generic Name: Gavilax
• Dosage Form: Powder, For Solution
• Route of Administration: ORAL
• Marketing Start Date: 2015-01-01
• Marketing Category: ANDA / ANDA
• Application Number: ANDA091077
• Labeler Name: DirectRX
• Substance Name: POLYETHYLENE GLYCOL 3350
• Active Ingredient Strength: 17 g/17g
• Pharm Classes: Osmotic Activity [MoA],Osmotic Laxative [EPC],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]
• NDC Exclude Flag: E
• Listing Certified Through: 2017-12-31

Packaging

NDC 61919-542-51

510 g in 1 BOTTLE (61919-542-51)

• Marketing Start Date: 2015-01-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 61919-542-51 [61919054251]

GAVILAX POWDER, FOR SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA091077
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: GM
• Marketing Start Date: 2015-01-01

Drug Details

Active Ingredients

Ingredient	Strength
POLYETHYLENE GLYCOL 3350	17 g/17g

OpenFDA Data

• SPL SET ID: 267de1ce-baa2-5a0b-e054-00144ff8d46c
• Manufacturer:
  • DirectRX
• UNII:
  • G2M7P15E5P
• RxNorm Concept Unique ID - RxCUI:
  • 876193

Pharmacological Class

• Osmotic Activity [MoA]
• Osmotic Laxative [EPC]
• Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]

NDC Crossover Matching brand name "GAVILAX" or generic name "Gavilax"

NDC	Brand Name	Generic Name
17856-0312	GAVILAX	Polyethylene Glycol 3350
43386-312	GAVILAX	Polyethylene Glycol 3350
50090-5310	GAVILAX	Polyethylene Glycol 3350
61919-542	GAVILAX	GAVILAX
63187-368	GAVILAX	Polyethylene Glycol 3350
68788-7508	GAVILAX	Polyethylene Glycol 3350
68788-9849	GAVILAX	Polyethylene Glycol 3350