NDC codes

FDA NDC Directory
Product NDC (as listed)70771-1863Labeler and product segments. Claims need a package NDC.
Product NDC at billing width70771-1863Add 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 NDC11-digit (billing)PackageCopy
70771-1863-6707711863067077118630660 TABLET in 1 BOTTLE (70771-1863-6)Marketed from Jul 2, 2024
70771-1863-87077118630870771186308180 TABLET in 1 BOTTLE (70771-1863-8)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 — 5 mg/1
Dosage form
Tablet
Route
Oral
Labeler
Zydus Lifesciences LimitedNDC labeler code 70771
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 70771-1863_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

N470771186306 followed by a unit qualifier and the quantity

Package 70771-1863-06. 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 .

Full label on DailyMed (opens in a new tab)

About NDC 70771-1863

What is NDC 70771-1863?
70771-1863 is the product NDC for ivabradine, Ivabradine hydrochloride 5 mg/1 tablet, listed with the FDA by Zydus Lifesciences 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?
Zydus Lifesciences Limited, NDC labeler code 70771. 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
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
IvabradineIvabradine hydrochloride 5 mg/1Tablet, Film coatedOralAmerican Health Packaging60687-86260687-0862-21
IvabradineIvabradine hydrochloride 5 mg/1Tablet, Film coatedOralNovadoz Pharmaceuticals LLC72205-33672205-0336-1872205-0336-60
IvabradineIvabradine hydrochloride 7.5 mg/1Tablet, Film coatedOralNovadoz Pharmaceuticals LLC72205-33772205-0337-1872205-0337-60
IvabradineIvabradine hydrochloride 5 mg/1Tablet, Film coatedOralNorthstar Rx LLC72603-93472603-0934-01
IvabradineIvabradine hydrochloride 7.5 mg/1Tablet, Film coatedOralNorthstar Rx LLC72603-93572603-0935-01
ivabradineIvabradine hydrochloride 5 mg/1Tablet, Film coatedOralBionpharma Inc.69452-19069452-0190-1769452-0190-30
ivabradineIvabradine hydrochloride 7.5 mg/1Tablet, Film coatedOralBionpharma Inc.69452-19169452-0191-1769452-0191-30
IvabradineIvabradine hydrochloride 5 mg/1Tablet, Film coatedOralAlembic Pharmaceuticals Limited46708-67946708-0679-4546708-0679-60
IvabradineIvabradine hydrochloride 7.5 mg/1Tablet, Film coatedOralAlembic Pharmaceuticals Limited46708-68046708-0680-4546708-0680-60
IvabradineIvabradine hydrochloride 5 mg/1Tablet, Film coatedOralAlembic Pharmaceuticals Inc.62332-67962332-0679-4562332-0679-60

All 21 ivabradine NDCs

Other NDCs under ANDA 213442

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

FDA NDC Directory listings under ANDA 213442
ProductStrengthForm · routeLabelerProduct NDC
ivabradineIvabradine hydrochloride 5 mg/1TabletOralZydus Pharmaceuticals USA Inc.70710-1471
ivabradineIvabradine hydrochloride 7.5 mg/1TabletOralZydus Pharmaceuticals USA Inc.70710-1472
ivabradineIvabradine hydrochloride 7.5 mg/1TabletOralZydus Lifesciences Limited70771-1864

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