NDC 50382-002

Saline Enema

Saline Enema

Saline Enema is a Rectal Enema in the Human Otc Drug category. It is labeled and distributed by Galentic Pharma (india) Priva Te Ltd.. The primary component is Sodium Phosphate, Dibasic; Sodium Phosphate, Monobasic.

• Product ID: 50382-002_43a17fc1-50a5-4be9-85d2-b0d7ed36be2b
• NDC: 50382-002
• Product Type: Human Otc Drug
• Proprietary Name: Saline Enema
• Generic Name: Saline Enema
• Dosage Form: Enema
• Route of Administration: RECTAL
• Marketing Start Date: 2013-08-01
• Marketing Category: OTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
• Application Number: part334
• Labeler Name: Galentic Pharma (India) Priva Te Ltd.
• 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 50382-002-01

118 mL in 1 BOTTLE (50382-002-01)

• Marketing Start Date: 2013-08-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 50382-002-01 [50382000201]

Saline Enema ENEMA

• Marketing Category: OTC monograph not final
• Application Number: part334
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2013-08-01
• Inactivation Date: 2019-11-27

Drug Details

Active Ingredients

Ingredient	Strength
SODIUM PHOSPHATE, DIBASIC	7 g/118mL

OpenFDA Data

• SPL SET ID: 619f934e-ac71-4447-a17b-1a30d1073b36
• Manufacturer:
  • Galentic Pharma (India) Priva Te Ltd.
• UNII:
  • 3980JIH2SW
  • GR686LBA74
• RxNorm Concept Unique ID - RxCUI:
  • 283100

NDC Crossover Matching brand name "Saline Enema" or generic name "Saline Enema"

NDC	Brand Name	Generic Name
50382-002	Saline Enema	SALINE ENEMA
61767-002	Saline enema	SALINE ENEMA
67777-402	Saline Enema	Sodium Phosphate Monobasic, Sodium Phosphate Dibasic