ivabradine
- Product NDC
- 70710-1472
- 11-digit product format
- 707101472
- Labeler code
- 70710
- Product ID
- 70710-1472_cbea8583-e207-402a-b79a-83ff14a3fa9b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ivabradine
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Zydus Pharmaceuticals USA Inc.
- Application
- ANDA213442
- Marketing category
- ANDA
- Marketing start
- 2024-07-02
- 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 |
|---|
| 70710-1472-6 | ivabradine | 60 in 1 BOTTLE | TABLET | 60 | | 1 |
| 70710-1472-8 | ivabradine | 180 in 1 BOTTLE | TABLET | 180 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70710-1472 | IVABRADINE TABLET [ZYDUS PHARMACEUTICALS USA INC.] | 1 | Current NDC, 2 package rows | 20240702_89134202-971b-4413-a9c9-d31a5c29722b.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 70710-1472-6 | 70710147206 | 60 TABLET in 1 BOTTLE (70710-1472-6) | 60 tablet | 2024-07-02 | No | No | Current |
| 70710-1472-8 | 70710147208 | 180 TABLET in 1 BOTTLE (70710-1472-8) | 180 tablet | 2024-07-02 | No | No | Current |