FDA.reportPublic FDA data

Ivabradine

Product NDC
31722-053
11-digit product format
317220053
Labeler code
31722
Product ID
31722-053_174dfa8e-391c-3a0d-e063-6294a90af7ca
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ivabradine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Camber Pharmaceuticals, Inc.
Application
ANDA213366
Marketing category
ANDA
Marketing start
2022-10-05
Substance
IVABRADINE HYDROCHLORIDE
Active strength
5 mg/1
Pharmacologic classes
Hyperpolarization-activated Cyclic Nucleotide-gated Channel Antagonists [MoA], Hyperpolarization-activated Cyclic Nucleotide-gated Channel Blocker [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
IVABRADINE HYDROCHLORIDE5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiTP19837BZK
Rxcui1649485, 1649493

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
eebd3ed3-f483-47f1-9e64-83ee4010ac6eProduct name520260130

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
31722-053-60Ivabradine60 in 1 BOTTLETABLET, FILM COATED601

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
31722-053-60EA - Each31722-05399da144d-83bc-40bf-992e-27c208fac58512024-08-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
31722-053IVABRADINE (IVABRADINE) TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.]1Current NDC, 1 package rows20240501_602d1c55-0e4d-452a-a087-888fdbaa7568.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1649485ivabradine 5 MG Oral TabletPSNe881a1ac-9221-4682-939f-966679cfe2862
1649485ivabradine 5 MG Oral TabletSCDe881a1ac-9221-4682-939f-966679cfe2862
1649485ivabradine 5 MG (as ivabradine HCl 5.39 MG) Oral TabletSYe881a1ac-9221-4682-939f-966679cfe2862
1649485ivabradine 5 MG Oral TabletPSN602d1c55-0e4d-452a-a087-888fdbaa75681
1649493ivabradine 7.5 MG Oral TabletPSN602d1c55-0e4d-452a-a087-888fdbaa75681
1649485ivabradine 5 MG Oral TabletSCD602d1c55-0e4d-452a-a087-888fdbaa75681
1649493ivabradine 7.5 MG Oral TabletSCD602d1c55-0e4d-452a-a087-888fdbaa75681
1649485ivabradine 5 MG (as ivabradine HCl 5.39 MG) Oral TabletSY602d1c55-0e4d-452a-a087-888fdbaa75681
1649493ivabradine 7.5 MG (as ivabradine HCl 8.085 MG) Oral TabletSY602d1c55-0e4d-452a-a087-888fdbaa75681

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
31722-053-603172200536060 TABLET, FILM COATED in 1 BOTTLE (31722-053-60) 2022-10-05NoNoHistorical