FDA.reportPublic FDA data

Ranolazine

Product NDC
71205-868
11-digit product format
712050868
Labeler code
71205
Product ID
71205-868_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
1000 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
RANOLAZINE1000 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
71205-868-00Ranolazine100 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE1002
71205-868-30Ranolazine30 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE302
71205-868-55Ranolazine500 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE5002
71205-868-60Ranolazine60 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE602
71205-868-72Ranolazine120 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE1202
71205-868-78Ranolazine180 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE1802
71205-868-90Ranolazine90 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-868-00EA - Each71205-868d5b7e212-f94a-41bd-8295-2f7a8c533e2212022-02-07
71205-868-30EA - Each71205-8680be43af2-0f06-41d5-90a4-6654f981414c12022-02-07
71205-868-55EA - Each71205-8688f6a493a-34c2-404b-8bb7-d81f779adc1812022-02-07
71205-868-60EA - Each71205-868ff8a41e7-0b20-481a-ab24-c515f9203c7712022-02-07
71205-868-72EA - Each71205-86848be6d26-321c-40dd-8052-452d25d07ad712022-02-07
71205-868-78EA - Each71205-8683142cbf8-381a-4343-9fe8-416e0764c85e12022-02-07
71205-868-90EA - Each71205-8683c0ca0c2-b08a-42d6-bbee-e2dbc016967912022-02-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-868RANOLAZINE 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
71205-868-0071205086800100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71205-868-00) 2021-12-170000-00-00NoNoCurrent
71205-868-307120508683030 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71205-868-30) 2021-12-170000-00-00NoNoCurrent
71205-868-5571205086855500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71205-868-55) 2021-12-170000-00-00NoNoCurrent
71205-868-607120508686060 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71205-868-60) 2021-12-170000-00-00NoNoCurrent
71205-868-7271205086872120 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71205-868-72) 2021-12-170000-00-00NoNoCurrent
71205-868-7871205086878180 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71205-868-78) 2021-12-170000-00-00NoNoCurrent
71205-868-907120508689090 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71205-868-90) 2021-12-170000-00-00NoNoCurrent