NDC 53113-104

Gadavyt Enema

Dibasic Sodium Phosphate, Monobasic Sodium Phosphate

Gadavyt Enema is a Rectal Liquid in the Human Otc Drug category. It is labeled and distributed by Gadal Laboratories Inc. The primary component is Sodium Phosphate, Dibasic; Sodium Phosphate, Monobasic.

• Product ID: 53113-104_b41d79c8-cdd2-410e-9921-3ca86f040b8f
• NDC: 53113-104
• Product Type: Human Otc Drug
• Proprietary Name: Gadavyt Enema
• Generic Name: Dibasic Sodium Phosphate, Monobasic Sodium Phosphate
• Dosage Form: Liquid
• Route of Administration: RECTAL
• Marketing Start Date: 2012-10-01
• Marketing Category: OTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
• Application Number: part334
• Labeler Name: Gadal Laboratories Inc
• Substance Name: SODIUM PHOSPHATE, DIBASIC; SODIUM PHOSPHATE, MONOBASIC
• Active Ingredient Strength: 7 g/118mL; g/118mL
• NDC Exclude Flag: E
• Listing Certified Through: 2017-12-31

Packaging

NDC 53113-104-45

133 mL in 1 BOTTLE, WITH APPLICATOR (53113-104-45)

• Marketing Start Date: 2012-10-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 53113-104-45 [53113010445]

Gadavyt Enema LIQUID

• Marketing Category: OTC monograph not final
• Application Number: part334
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2012-10-01
• Inactivation Date: 2019-11-27

Drug Details

Active Ingredients

Ingredient	Strength
SODIUM PHOSPHATE, DIBASIC	7 g/118mL

OpenFDA Data

• SPL SET ID: 8d47021a-c973-4a25-acc3-98e3001ec8db
• Manufacturer:
  • Gadal Laboratories Inc
• UNII:
  • 3980JIH2SW
  • GR686LBA74
• RxNorm Concept Unique ID - RxCUI:
  • 283100

NDC Crossover Matching brand name "Gadavyt Enema" or generic name "Dibasic Sodium Phosphate, Monobasic Sodium Phosphate"

NDC	Brand Name	Generic Name
53113-104	Gadavyt Enema	dibasic sodium phosphate, monobasic sodium phosphate
53113-105	Gadavyt Enema	dibasic sodium phosphate, monobasic sodium phosphate
0363-0126	Oral Saline Laxative	dibasic sodium phosphate, monobasic sodium phosphate
0363-0127	Oral Saline Laxative	dibasic sodium phosphate, monobasic sodium phosphate
30142-111	Oral Saline Laxative	dibasic sodium phosphate, monobasic sodium phosphate
41163-111	Oral Saline Laxative	dibasic sodium phosphate, monobasic sodium phosphate
49348-110	Oral Saline Laxative	dibasic sodium phosphate, monobasic sodium phosphate
49348-111	Oral Saline Laxative	dibasic sodium phosphate, monobasic sodium phosphate
49738-111	Oral Saline Laxative	dibasic sodium phosphate, monobasic sodium phosphate
59779-111	Oral Saline Laxative	dibasic sodium phosphate, monobasic sodium phosphate
36800-002	topcare enema	Dibasic sodium phosphate, Monobasic sodium phosphate
11673-002	up and up ready to use enema	Dibasic sodium phosphate, Monobasic sodium phosphate