Ivabradine
- Product NDC
- 60687-862
- 11-digit product format
- 606870862
- Labeler code
- 60687
- Product ID
- 60687-862_38e0b27f-e2e8-d69e-e063-6394a90a21dd
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ivabradine
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- American Health Packaging
- Application
- ANDA213366
- Marketing category
- ANDA
- Marketing start
- 2025-07-01
- 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| Ingredient | Strength |
|---|
| IVABRADINE HYDROCHLORIDE | 5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | TP19837BZK |
| Rxcui | 1649485 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 60687-862-11 | Ivabradine | 1 in 1 BLISTER PACK | TABLET, FILM COATED | 1 | | 2 |
| 60687-862-21 | Ivabradine | 30 in 1 CARTON | TABLET, FILM COATED | 30 | | 2 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 60687-862-11 | 60687086211 | 1 in 1 BLISTER PACK | | | | | Historical |
| 60687-862-21 | 60687086221 | 30 BLISTER PACK in 1 CARTON (60687-862-21) / 1 TABLET, FILM COATED in 1 BLISTER PACK (60687-862-11) | 30 blister pack | 2025-07-01 | No | No | Historical |