FDA.reportPublic FDA data

Ranolazine

Product NDC
31722-669
11-digit product format
317220669
Labeler code
31722
Product ID
31722-669_dedfd14d-159a-50cc-e053-2995a90a016b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ranolazine
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Camber Pharmaceuticals, Inc.
Application
ANDA212788
Marketing category
ANDA
Marketing start
2022-05-05
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
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
ddc83a74-720a-4975-8550-c4bd979c9094Product name120221212
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
31722-669-60Ranolazine60 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE601

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
31722-669-60EA - Each31722-66958c84da7-95f5-4cb4-8e18-c0652e7f593312023-03-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
31722-669RANOLAZINE TABLET, FILM COATED, EXTENDED RELEASE [CAMBER PHARMACEUTICALS, INC.]1Current NDC, Legacy NDC, 1 package rows20220514_82948cdb-73af-4f3f-bd03-628ed0fdbfba.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
728231ranolazine 1000 MG 12HR Extended Release Oral TabletPSN82948cdb-73af-4f3f-bd03-628ed0fdbfba1
616749ranolazine 500 MG 12HR Extended Release Oral TabletPSN82948cdb-73af-4f3f-bd03-628ed0fdbfba1
72823112 HR ranolazine 1000 MG Extended Release Oral TabletSCD82948cdb-73af-4f3f-bd03-628ed0fdbfba1
61674912 HR ranolazine 500 MG Extended Release Oral TabletSCD82948cdb-73af-4f3f-bd03-628ed0fdbfba1
728231ranolazine 1000 MG 12 HR Extended Release Oral TabletSY82948cdb-73af-4f3f-bd03-628ed0fdbfba1
616749ranolazine 500 MG 12 HR Extended Release Oral TabletSY82948cdb-73af-4f3f-bd03-628ed0fdbfba1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
31722-669-603172206696060 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (31722-669-60) 2022-05-050000-00-00NoNoCurrent