RANOLAZINE

Product NDC: 51407-225
11-digit product format: 514070225
Labeler code: 51407
Product ID: 51407-225_dc7a27bc-b862-7e4c-e053-2a95a90aba00
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: RANOLAZINE
Dosage form: TABLET, FILM COATED, EXTENDED RELEASE
Route: ORAL
Labeler: Golden State Medical Supply
Application: ANDA211829
Marketing category: ANDA
Marketing start: 2019-06-04
Marketing end: 2022-07-31
Substance: RANOLAZINE
Active strength: 500 mg/1
Pharmacologic classes: Anti-anginal [EPC], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 0000-00-00
Current FDA listing: Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
4367aed1-e488-b72c-d0ec-178a4e054129	Product name	9	20250624
ddc83a74-720a-4975-8550-c4bd979c9094	Product name	1	20221212

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
51407-225-60	EA - Each	51407-225	f152f212-ce33-488a-a579-cc1a443018d3	1	2019-07-02

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
A6IEZ5M406	RANOLAZINE	95635-55-5	RANOLAZINE

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
616749	ranolazine 500 MG 12HR Extended Release Oral Tablet	PSN	c842805c-c78d-474e-8a33-c2e828bad800	1
616749	12 HR ranolazine 500 MG Extended Release Oral Tablet	SCD	c842805c-c78d-474e-8a33-c2e828bad800	1
616749	ranolazine 500 MG 12 HR Extended Release Oral Tablet	SY	c842805c-c78d-474e-8a33-c2e828bad800	1

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
51407-225-60	51407022560	60 TABLET, FILM COATED, EXTENDED RELEASE in 1 PACKAGE (51407-225-60)	2019-06-06	0000-00-00	No	No	Current