What is NDC 46708-680?

46708-680 is the product NDC for Ivabradine, Ivabradine hydrochloride 7.5 mg/1 tablet, film coated, listed with the FDA by Alembic Pharmaceuticals Limited. It has 2 package NDCs, shown above in 10- and 11-digit form.

Alembic Pharmaceuticals Limited, NDC labeler code 46708. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Ivabradine?

20 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Ivabradine NDC 46708-680 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)46708-680Labeler and product segments. Claims need a package NDC.

Product NDC at billing width46708-0680Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
46708-680-45	4670806804546708068045	180 TABLET, FILM COATED in 1 BOTTLE (46708-680-45)Marketed from Dec 20, 2024
46708-680-60	4670806806046708068060	60 TABLET, FILM COATED in 1 BOTTLE (46708-680-60)Marketed from Dec 20, 2024

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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, Film coated
Route: Oral
Labeler: Alembic Pharmaceuticals LimitedNDC labeler code 46708
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 215238
Marketing start: Dec 20, 2024
Listing expires: Dec 31, 2027
Other FDA classes: Hyperpolarization-activated Cyclic Nucleotide-gated Channel Antagonists (Mechanism)
Identifiers: Product ID 46708-680_51ac7345-3188-4382-ab1d-9120d6c88927SPL ID 51ac7345-3188-4382-ab1d-9120d6c88927SPL set ID 51ac7345-3188-4382-ab1d-9120d6c88927RxCUI 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

N446708068045 followed by a unit qualifier and the quantity

Package 46708-0680-45. 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 Sep 30, 2024.

Indications (excerpt from the label)

Ivabradine tablets are hyperpolarization-activated cyclic nucleotide-gated channel blocker indicated: To reduce the risk of hospitalization for worsening heart failure in adult patients with stable, symptomatic chronic heart failure with reduced left ventricular ejection fraction. ( 1.1 ) 1.1 Heart Failure in Adult Patients Ivabradine tablets are indicated to reduce the risk of hospitalization for worsening heart failure in adult patients with stable, symptomatic chronic heart failure with left ventricular ejection fraction ≤ 35%, who are in sinus rhythm with resting heart rate ≥ 70 beats per minute and either are on maximally tolerated doses of beta-blockers or have a contraindication to be…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 46708-680

What is NDC 46708-680?: 46708-680 is the product NDC for Ivabradine, Ivabradine hydrochloride 7.5 mg/1 tablet, film coated, listed with the FDA by Alembic Pharmaceuticals Limited. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Ivabradine.
What is the active ingredient?: Ivabradine hydrochloride.
Who is the labeler?: Alembic Pharmaceuticals Limited, NDC labeler code 46708. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Ivabradine?: 20 other product NDCs are listed under this name. See all Ivabradine NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Ivabradine NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Ivabradine	Ivabradine hydrochloride 5 mg/1	Tablet, Film coatedOral	American Health Packaging	60687-862	60687-0862-21
Ivabradine	Ivabradine hydrochloride 5 mg/1	Tablet, Film coatedOral	Novadoz Pharmaceuticals LLC	72205-336	72205-0336-1872205-0336-60
Ivabradine	Ivabradine hydrochloride 7.5 mg/1	Tablet, Film coatedOral	Novadoz Pharmaceuticals LLC	72205-337	72205-0337-1872205-0337-60
Ivabradine	Ivabradine hydrochloride 5 mg/1	Tablet, Film coatedOral	Northstar Rx LLC	72603-934	72603-0934-01
Ivabradine	Ivabradine hydrochloride 7.5 mg/1	Tablet, Film coatedOral	Northstar Rx LLC	72603-935	72603-0935-01
ivabradine	Ivabradine hydrochloride 5 mg/1	Tablet, Film coatedOral	Bionpharma Inc.	69452-190	69452-0190-1769452-0190-30
ivabradine	Ivabradine hydrochloride 7.5 mg/1	Tablet, Film coatedOral	Bionpharma Inc.	69452-191	69452-0191-1769452-0191-30
Ivabradine	Ivabradine hydrochloride 5 mg/1	Tablet, Film coatedOral	Alembic Pharmaceuticals Limited	46708-679	46708-0679-4546708-0679-60
Ivabradine	Ivabradine hydrochloride 5 mg/1	Tablet, Film coatedOral	Alembic Pharmaceuticals Inc.	62332-679	62332-0679-4562332-0679-60
Ivabradine	Ivabradine hydrochloride 7.5 mg/1	Tablet, Film coatedOral	Alembic Pharmaceuticals Inc.	62332-680	62332-0680-4562332-0680-60

All 21 Ivabradine NDCs

Other NDCs under ANDA 215238

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 215238
Product	Strength	Form · route	Labeler	Product NDC
Ivabradine	Ivabradine hydrochloride 5 mg/1	Tablet, Film coatedOral	Alembic Pharmaceuticals Limited	46708-679
Ivabradine	Ivabradine hydrochloride 5 mg/1	Tablet, Film coatedOral	Alembic Pharmaceuticals Inc.	62332-679
Ivabradine	Ivabradine hydrochloride 7.5 mg/1	Tablet, Film coatedOral	Alembic Pharmaceuticals Inc.	62332-680