IVABRADINE
- Product NDC
- 51407-593
- 11-digit product format
- 514070593
- Labeler code
- 51407
- Product ID
- 51407-593_32d59c63-db88-3e0c-e063-6294a90acd9f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- IVABRADINE
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Golden State Medical Supply, Inc.
- Application
- ANDA214051
- Marketing category
- ANDA
- Marketing start
- 2021-12-30
- 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
- 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 | 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 |
|---|
| 51407-593-60 | IVABRADINE | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 51407-593 | IVABRADINE TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.] | 2 | Current NDC, 1 package rows | 20250424_236cc914-7eef-600c-e063-6394a90a4bd1.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 51407-593-60 | 51407059360 | 60 TABLET, FILM COATED in 1 BOTTLE (51407-593-60) | 2024-08-29 | No | No | Current |