FDA.reportPublic FDA data

Ranolazine

Product NDC
67877-526
11-digit product format
678770526
Labeler code
67877
Product ID
67877-526_05aa3d63-f0b2-4aff-8c82-847eec936579
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ranolazine
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Ascend Laboratories, LLC
Application
ANDA209953
Marketing category
ANDA
Marketing start
2020-12-02
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
67877-526-05Ranolazine500 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE5006
67877-526-38Ranolazine10 in 1 BLISTER PACKTABLET, FILM COATED, EXTENDED RE106
67877-526-38Ranolazine10 in 1 CARTONTABLET, FILM COATED, EXTENDED RE106
67877-526-60Ranolazine60 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE606

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67877-526-60EA - Each67877-526120f6adf-67ca-414f-92b9-88e977f8518812021-07-15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67877-526RANOLAZINE TABLET, FILM COATED, EXTENDED RELEASE [ASCEND LABORATORIES, LLC]5Current NDC, Legacy NDC, 4 package rows20220928_5b254a8e-db88-49be-bb48-e6d2847f8ab3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
728231ranolazine 1000 MG 12HR Extended Release Oral TabletPSN5b254a8e-db88-49be-bb48-e6d2847f8ab36
616749ranolazine 500 MG 12HR Extended Release Oral TabletPSN5b254a8e-db88-49be-bb48-e6d2847f8ab36
72823112 HR ranolazine 1000 MG Extended Release Oral TabletSCD5b254a8e-db88-49be-bb48-e6d2847f8ab36
61674912 HR ranolazine 500 MG Extended Release Oral TabletSCD5b254a8e-db88-49be-bb48-e6d2847f8ab36
728231ranolazine 1000 MG 12 HR Extended Release Oral TabletSY5b254a8e-db88-49be-bb48-e6d2847f8ab36
616749ranolazine 500 MG 12 HR Extended Release Oral TabletSY5b254a8e-db88-49be-bb48-e6d2847f8ab36
728231ranolazine 1000 MG 12HR Extended Release Oral TabletPSNe92350e8-5b0b-95d3-e053-2995a90a959b2
616749ranolazine 500 MG 12HR Extended Release Oral TabletPSNe92350e8-5b0b-95d3-e053-2995a90a959b2
72823112 HR ranolazine 1000 MG Extended Release Oral TabletSCDe92350e8-5b0b-95d3-e053-2995a90a959b2
61674912 HR ranolazine 500 MG Extended Release Oral TabletSCDe92350e8-5b0b-95d3-e053-2995a90a959b2
728231ranolazine 1000 MG 12 HR Extended Release Oral TabletSYe92350e8-5b0b-95d3-e053-2995a90a959b2
616749ranolazine 500 MG 12 HR Extended Release Oral TabletSYe92350e8-5b0b-95d3-e053-2995a90a959b2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67877-526-0567877052605500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (67877-526-05) 2020-12-020000-00-00NoNoCurrent
67877-526-386787705263810 BLISTER PACK in 1 CARTON (67877-526-38) / 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK10 blister pack2020-12-020000-00-00NoNoCurrent
67877-526-606787705266060 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (67877-526-60) 2020-12-020000-00-00NoNoCurrent