NDC 70518-0086

UROCIT-K

Potassium Citrate

UROCIT-K is a Oral Tablet, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Remedyrepack Inc.. The primary component is Potassium Citrate.

• Product ID: 70518-0086_8038189d-9276-2656-e053-2991aa0a7fc5
• NDC: 70518-0086
• Product Type: Human Prescription Drug
• Proprietary Name: UROCIT-K
• Generic Name: Potassium Citrate
• Dosage Form: Tablet, Extended Release
• Route of Administration: ORAL
• Marketing Start Date: 2016-12-27
• Marketing Category: NDA / NDA
• Application Number: NDA019071
• Labeler Name: REMEDYREPACK INC.
• Substance Name: POTASSIUM CITRATE
• Active Ingredient Strength: 10 meq/1
• Pharm Classes: Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 70518-0086-0

30 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (70518-0086-0)

• Marketing Start Date: 2016-12-27
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 70518-0086-0 [70518008600]

UROCIT-K TABLET, EXTENDED RELEASE

• Marketing Category: NDA
• Application Number: NDA019071
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2016-12-27
• Marketing End Date: 2018-01-19

Drug Details

Active Ingredients

Ingredient	Strength
POTASSIUM CITRATE	10 meq/1

OpenFDA Data

• SPL SET ID: 7485b87a-5621-4744-9b64-757730f7f449
• Manufacturer:
  • REMEDYREPACK INC.
• UNII:
  • EE90ONI6FF
• RxNorm Concept Unique ID - RxCUI:
  • 199381
  • 603281

Pharmacological Class

• Acidifying Activity [MoA]
• Calculi Dissolution Agent [EPC]
• Anti-coagulant [EPC]
• Decreased Coagulation Factor Activity [PE]
• Calcium Chelating Activity [MoA]

NDC Crossover Matching brand name "UROCIT-K" or generic name "Potassium Citrate"

NDC	Brand Name	Generic Name
0178-0600	UROCIT-K	potassium citrate
0178-0610	UROCIT-K	potassium citrate
0178-0615	UROCIT-K	potassium citrate
70518-0086	UROCIT-K	UROCIT-K
0245-0070	Potassium Citrate	potassium citrate
0245-0071	Potassium Citrate	potassium citrate