Prescription drug · ANDA
ivabradine NDC 70771-1864
Ivabradine hydrochloride 7.5 mg/1 · Tablet · Oral · Zydus Lifesciences Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70771-1864-6 | 70771186406 | 60 TABLET in 1 BOTTLE (70771-1864-6)Marketed from Jul 2, 2024 | |
| 70771-1864-8 | 70771186408 | 180 TABLET in 1 BOTTLE (70771-1864-8)Marketed from Jul 2, 2024 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- ivabradine
- Generic name (nonproprietary)
- ivabradine
- Active ingredients
- Ivabradine hydrochloride — 7.5 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Zydus Lifesciences Limited
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 213442
- Marketing start
- Listing expires
- Other FDA classes
- Hyperpolarization-activated Cyclic Nucleotide-gated Channel Antagonists (Mechanism)
- Identifiers
- Product ID 70771-1864_b83cc3b5-db55-4fc0-a89d-2cae17fcd445SPL ID b83cc3b5-db55-4fc0-a89d-2cae17fcd445SPL set ID 246b495a-ea7b-4cbe-9a5f-87c2c0a59cb3RxCUI 1649485, 1649493UNII TP19837BZK
- Pharmacologic class
- Hyperpolarization-activated Cyclic Nucleotide-gated Channel Blocker
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N470771186406followed by a unit qualifier and the quantityPackage 70771-1864-06. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Other NDCs under ANDA 213442
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| ivabradine | Ivabradine hydrochloride 5 mg/1 | TabletOral | Zydus Pharmaceuticals USA Inc. | 70710-1471 |
| ivabradine | Ivabradine hydrochloride 7.5 mg/1 | TabletOral | Zydus Pharmaceuticals USA Inc. | 70710-1472 |
| ivabradine | Ivabradine hydrochloride 5 mg/1 | TabletOral | Zydus Lifesciences Limited | 70771-1863 |