ranolazine
Generic: ranolazine
Labeler: lupin pharmaceuticals, inc.Drug Facts
Product Profile
Brand Name
ranolazine
Generic Name
ranolazine
Labeler
lupin pharmaceuticals, inc.
Dosage Form
TABLET, FILM COATED, EXTENDED RELEASE
Routes
Active Ingredients
ranolazine 500 mg/1
Manufacturer
Identifiers & Regulatory
Product NDC
68180-354
Product ID
68180-354_e5f38101-deda-4a41-8c51-76edce7df3e8
Product Type
HUMAN PRESCRIPTION DRUG
Marketing Category
ANDA
Application Number
ANDA201046
Listing Expiration
2026-12-31
Marketing Start
2019-02-27
Pharmacologic Class
Established (EPC)
Mechanism of Action
Normalized Code Variants
Searchable formats for this product NDC code
Digits Only
68180354
Hyphenated Format
68180-354
Supplemental Identifiers
RxCUI
UPC
UNII
NUI
Packaging Origin
Original Packager
Resolved Product View
Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.
Resolved Identity
Brand Name
ranolazine (source: ndc)
Generic Name
ranolazine (source: ndc)
Application Number
ANDA201046 (source: ndc)
Routes
source: ndc
Resolved Composition
Strengths
- 500 mg/1
Packaging
- 16 HOW SUPPLIED/STORAGE AND HANDLING Ranolazine extended-release tablets are supplied as film-coated, oval-shaped, extended-release tablets in the following strengths: 500 mg tablets are orange, debossed with "L31" on one side and "LU" on other side 1000 mg tablets are yellow, debossed with "L32" on one side and "LU" on other side Ranolazine extended-release tablets are available in: Strength NDC Code Bottles of 60 500 mg 68180-354-07 Bottles of 500 500 mg 68180-354-02 Bottles of 60 1000 mg 68180-355-07 Bottles of 500 1000 mg 68180-355-02 Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 68180-354-07 RANOLAZINE EXTENDED-RELEASE TABLETS 500 mg Rx only Container Label: Bottle of 60 Tablets NDC 68180-355-07 RANOLAZINE EXTENDED-RELEASE TABLETS 1000 mg Rx only Container Label: Bottle of 60 Tablets NDC 68180-354-07 RANOLAZINE EXTENDED-RELEASE TABLETS 500 mg Rx only Container Label: Bottle of 60 Tablets NDC 68180-355-07 RANOLAZINE EXTENDED-RELEASE TABLETS 1000 mg Rx only Container Label: Bottle of 60 Tablets
Packages (0)
No package records.
Ingredients (1)
Linked Drug Pages (1)
Raw FDA Data
View complete raw FDA NDC JSON payload
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