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NDC 68180-0354-02 RANOLAZINE 500 mg/1 Details

RANOLAZINE 500 mg/1

RANOLAZINE is a ORAL TABLET, FILM COATED, EXTENDED RELEASE in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Lupin Pharmaceuticals, Inc.. The primary component is RANOLAZINE.

MedlinePlus Drug Summary

Ranolazine is used alone or with other medications to treat chronic angina (ongoing chest pain or pressure that is felt when the heart does not get enough oxygen). Ranolazine is in a class of medications called anti-anginals. The exact way that ranolazine works is not known at this time.

Related Packages: 68180-0354-02
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Ranolazine

Product Information

NDC	68180-0354
Product ID	68180-354_e5f38101-deda-4a41-8c51-76edce7df3e8
Associated GPIs	32200040007420
GCN Sequence Number	060333
GCN Sequence Number Description	ranolazine TAB ER 12H 500 MG ORAL
HIC3	A2C
HIC3 Description	ANTIANGINAL, ANTI-ISCHEMIC AGENTS,NON-HEMODYNAMIC
GCN	26459
HICL Sequence Number	033446
HICL Sequence Number Description	RANOLAZINE
Brand/Generic	Generic
Proprietary Name	RANOLAZINE
Proprietary Name Suffix	n/a
Non-Proprietary Name	RANOLAZINE
Product Type	HUMAN PRESCRIPTION DRUG
Dosage Form	TABLET, FILM COATED, EXTENDED RELEASE
Route	ORAL
Active Ingredient Strength	500
Active Ingredient Units	mg/1
Substance Name	RANOLAZINE
Labeler Name	Lupin Pharmaceuticals, Inc.
Pharmaceutical Class	Anti-anginal [EPC], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]
DEA Schedule	n/a
Marketing Category	ANDA
Application Number	ANDA201046
Listing Certified Through	2024-12-31

Package

NDC 68180-0354-02 (68180035402)

Pricing Information	N/A
NDC Package Code	68180-354-02
Billing NDC	68180035402
Package	500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68180-354-02)
Marketing Start Date	2019-02-27
NDC Exclude Flag	N