FDA.reportPublic FDA data

Ranolazine

Product NDC
71205-867
11-digit product format
712050867
Labeler code
71205
Product ID
71205-867_278d3fa3-3304-43dc-8a2a-a463c8ae9e9d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ranolazine
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA211829
Marketing category
ANDA
Marketing start
2021-08-24
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Ranolazine
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
RANOLAZINE500 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiA6IEZ5M406
Rxcui616749, 728231

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4367aed1-e488-b72c-d0ec-178a4e054129Product name920250624
ddc83a74-720a-4975-8550-c4bd979c9094Product name120221212

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71205-867-00Ranolazine100 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE1002
71205-867-30Ranolazine30 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE302
71205-867-55Ranolazine500 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE5002
71205-867-60Ranolazine60 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE602
71205-867-72Ranolazine120 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE1202
71205-867-78Ranolazine180 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE1802
71205-867-90Ranolazine90 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-867-00EA - Each71205-86750b7040d-a1b9-470b-87bd-906b99742aed12022-01-06
71205-867-30EA - Each71205-8671f3fc6e1-be93-4b45-991f-803155d4434c12022-01-06
71205-867-55EA - Each71205-867eae5da17-1c21-4333-bd15-e9d153ce3a1212022-01-06
71205-867-60EA - Each71205-8672a9e73bc-b6a0-4ea4-a70c-e214759b718f12022-01-06
71205-867-72EA - Each71205-867dba42a78-a83a-4cfb-869b-98e0ada4d66212022-01-06
71205-867-78EA - Each71205-8670f14d934-dfbe-437f-9d74-ff1ec7fb744312022-01-06
71205-867-90EA - Each71205-86763e75d7d-c934-453c-b3d1-6cc4ba41e19c12022-01-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-867RANOLAZINE TABLET, FILM COATED, EXTENDED RELEASE [PROFICIENT RX LP]2Current NDC, Legacy NDC, 7 package rows20220402_989e1688-a0b5-4297-bf91-234de2a0b445.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
728231ranolazine 1000 MG 12HR Extended Release Oral TabletPSN989e1688-a0b5-4297-bf91-234de2a0b4452
616749ranolazine 500 MG 12HR Extended Release Oral TabletPSN989e1688-a0b5-4297-bf91-234de2a0b4452
72823112 HR ranolazine 1000 MG Extended Release Oral TabletSCD989e1688-a0b5-4297-bf91-234de2a0b4452
61674912 HR ranolazine 500 MG Extended Release Oral TabletSCD989e1688-a0b5-4297-bf91-234de2a0b4452
728231ranolazine 1000 MG 12 HR Extended Release Oral TabletSY989e1688-a0b5-4297-bf91-234de2a0b4452
616749ranolazine 500 MG 12 HR Extended Release Oral TabletSY989e1688-a0b5-4297-bf91-234de2a0b4452

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71205-867-0071205086700100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71205-867-00) 2021-12-170000-00-00NoNoCurrent
71205-867-307120508673030 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71205-867-30) 2021-12-170000-00-00NoNoCurrent
71205-867-5571205086755500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71205-867-55) 2021-12-170000-00-00NoNoCurrent
71205-867-607120508676060 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71205-867-60) 2021-12-170000-00-00NoNoCurrent
71205-867-7271205086772120 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71205-867-72) 2021-12-170000-00-00NoNoCurrent
71205-867-7871205086778180 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71205-867-78) 2021-12-170000-00-00NoNoCurrent
71205-867-907120508679090 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71205-867-90) 2021-12-170000-00-00NoNoCurrent