Ivabradine
- Product NDC
- 72603-935
- 11-digit product format
- 726030935
- Labeler code
- 72603
- Product ID
- 72603-935_a7fb4728-1c41-4c01-8adb-a22dca0b1b1b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ivabradine
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Northstar Rx LLC
- Application
- ANDA213483
- Marketing category
- ANDA
- Marketing start
- 2025-04-28
- Substance
- IVABRADINE HYDROCHLORIDE
- Active strength
- 7.5 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
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Ivabradine
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| IVABRADINE HYDROCHLORIDE | 7.5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | TP19837BZK |
| Rxcui | 1649485, 1649493 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 72603-935-01 | Ivabradine | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 3 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 72603-935-01 | 72603093501 | 60 in 1 BOTTLE | Historical |