NDC 70518-1220

Amlodipine, Valsartan and Hydrochlorothiazide

Amlodipine, Valsartan And Hydrochlorothiazide

Amlodipine, Valsartan and Hydrochlorothiazide is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Remedyrepack Inc.. The primary component is Amlodipine Besylate; Valsartan; Hydrochlorothiazide.

• Product ID: 70518-1220_6cbe11bc-9ae1-2d34-e053-2a91aa0ab4ce
• NDC: 70518-1220
• Product Type: Human Prescription Drug
• Proprietary Name: Amlodipine, Valsartan and Hydrochlorothiazide
• Generic Name: Amlodipine, Valsartan And Hydrochlorothiazide
• Dosage Form: Tablet
• Route of Administration: ORAL
• Marketing Start Date: 2018-05-21
• Marketing Category: ANDA / ANDA
• Application Number: ANDA201593
• Labeler Name: REMEDYREPACK INC.
• Substance Name: AMLODIPINE BESYLATE; VALSARTAN; HYDROCHLOROTHIAZIDE
• Active Ingredient Strength: 10 mg/1; mg/1; mg/1
• Pharm Classes: Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS],Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [CS]
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 70518-1220-0

90 TABLET in 1 BOTTLE, PLASTIC (70518-1220-0)

• Marketing Start Date: 2018-05-21
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 70518-1220-0 [70518122000]

Amlodipine, Valsartan and Hydrochlorothiazide TABLET

• Marketing Category: ANDA
• Application Number: ANDA201593
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2018-05-21
• Marketing End Date: 2020-03-27

Drug Details

Active Ingredients

Ingredient	Strength
AMLODIPINE BESYLATE	10 mg/1

OpenFDA Data

• SPL SET ID: c469ee49-3698-4063-8663-1d307fa9cced
• Manufacturer:
  • REMEDYREPACK INC.
• UNII:
  • 864V2Q084H
  • 0J48LPH2TH
  • 80M03YXJ7I
• RxNorm Concept Unique ID - RxCUI:
  • 848135

Pharmacological Class

• Calcium Channel Antagonists [MoA]
• Dihydropyridine Calcium Channel Blocker [EPC]
• Dihydropyridines [CS]
• Angiotensin 2 Receptor Antagonists [MoA]
• Angiotensin 2 Receptor Blocker [EPC]
• Increased Diuresis [PE]
• Thiazide Diuretic [EPC]
• Thiazides [CS]

NDC Crossover Matching brand name "Amlodipine, Valsartan and Hydrochlorothiazide" or generic name "Amlodipine, Valsartan And Hydrochlorothiazide"

NDC	Brand Name	Generic Name
13668-325	Amlodipine, Valsartan and Hydrochlorothiazide	Amlodipine, Valsartan and Hydrochlorothiazide
13668-326	Amlodipine, Valsartan and Hydrochlorothiazide	Amlodipine, Valsartan and Hydrochlorothiazide
13668-327	Amlodipine, Valsartan and Hydrochlorothiazide	Amlodipine, Valsartan and Hydrochlorothiazide
13668-328	Amlodipine, Valsartan and Hydrochlorothiazide	Amlodipine, Valsartan and Hydrochlorothiazide
13668-329	Amlodipine, Valsartan and Hydrochlorothiazide	Amlodipine, Valsartan and Hydrochlorothiazide
57297-771	Amlodipine, Valsartan and Hydrochlorothiazide	Amlodipine, Valsartan and Hydrochlorothiazide
57297-772	Amlodipine, Valsartan and Hydrochlorothiazide	Amlodipine, Valsartan and Hydrochlorothiazide
57297-773	Amlodipine, Valsartan and Hydrochlorothiazide	Amlodipine, Valsartan and Hydrochlorothiazide
57297-774	Amlodipine, Valsartan and Hydrochlorothiazide	Amlodipine, Valsartan and Hydrochlorothiazide
57297-775	Amlodipine, Valsartan and Hydrochlorothiazide	Amlodipine, Valsartan and Hydrochlorothiazide
65862-834	Amlodipine, Valsartan and Hydrochlorothiazide	Amlodipine, Valsartan and Hydrochlorothiazide
65862-835	Amlodipine, Valsartan and Hydrochlorothiazide	Amlodipine, Valsartan and Hydrochlorothiazide
65862-836	Amlodipine, Valsartan and Hydrochlorothiazide	Amlodipine, Valsartan and Hydrochlorothiazide
65862-837	Amlodipine, Valsartan and Hydrochlorothiazide	Amlodipine, Valsartan and Hydrochlorothiazide
65862-838	Amlodipine, Valsartan and Hydrochlorothiazide	Amlodipine, Valsartan and Hydrochlorothiazide
68180-771	Amlodipine, Valsartan and Hydrochlorothiazide	Amlodipine, Valsartan and Hydrochlorothiazide
68180-772	Amlodipine, Valsartan and Hydrochlorothiazide	Amlodipine, Valsartan and Hydrochlorothiazide
68180-773	Amlodipine, Valsartan and Hydrochlorothiazide	Amlodipine, Valsartan and Hydrochlorothiazide
68180-775	Amlodipine, Valsartan and Hydrochlorothiazide	Amlodipine, Valsartan and Hydrochlorothiazide
68180-774	Amlodipine, Valsartan and Hydrochlorothiazide	Amlodipine, Valsartan and Hydrochlorothiazide
70518-1220	Amlodipine, Valsartan and Hydrochlorothiazide	Amlodipine, Valsartan and Hydrochlorothiazide