What is NDC 70771-1018?

70771-1018 is the product NDC for Bosentan, Bosentan 125 mg/1 tablet, listed with the FDA by Zydus Lifesciences Limited. It has 5 package NDCs, shown above in 10- and 11-digit form.

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 Bosentan?

10 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Bosentan NDC 70771-1018 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)70771-1018Labeler and product segments. Claims need a package NDC.

Product NDC at billing width70771-1018Add 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
70771-1018-1	7077110180170771101801	100 TABLET in 1 BOTTLE (70771-1018-1)Marketed from May 1, 2019
70771-1018-4	7077110180470771101804	10 BLISTER PACK in 1 CARTON (70771-1018-4) / 10 TABLET in 1 BLISTER PACK (70771-1018-2)Marketed from May 1, 2019
70771-1018-5	7077110180570771101805	500 TABLET in 1 BOTTLE (70771-1018-5)Marketed from May 1, 2019
70771-1018-6	7077110180670771101806	60 TABLET in 1 BOTTLE (70771-1018-6)Marketed from May 1, 2019
70771-1018-8	7077110180870771101808	180 TABLET in 1 BOTTLE (70771-1018-8)Marketed from May 1, 2019

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): Bosentan
Generic name (nonproprietary): bosentan
Active ingredients: Bosentan — 125 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 207760
Marketing start: May 1, 2019
Listing expires: Dec 31, 2027
Other FDA classes: Cytochrome P450 2C9 Inducers (Mechanism)Cytochrome P450 3A Inducers (Mechanism)Endothelin Receptor Antagonists (Mechanism)
Identifiers: Product ID 70771-1018_33935d05-c8ff-4d9e-91bf-fac9072d25fdSPL ID 33935d05-c8ff-4d9e-91bf-fac9072d25fdSPL set ID 02892f47-0d59-4254-9ee7-d524278fdd79RxCUI 349253, 656659UNII Q326023R30
Pharmacologic class: Endothelin Receptor Antagonist

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

N470771101801 followed by a unit qualifier and the quantity

Package 70771-1018-01. 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 Nov 25, 2024.

Full label on DailyMed (opens in a new tab)

About NDC 70771-1018

What is NDC 70771-1018?: 70771-1018 is the product NDC for Bosentan, Bosentan 125 mg/1 tablet, listed with the FDA by Zydus Lifesciences Limited. It has 5 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Bosentan.
What is the active ingredient?: Bosentan.
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 Bosentan?: 10 other product NDCs are listed under this name. See all Bosentan 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 Bosentan NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
bosentan	Bosentan 32 mg/1	Tablet, For suspensionOral	Zydus Pharmaceuticals USA Inc.	70710-1508	70710-1508-08
bosentan	Bosentan 32 mg/1	Tablet, For suspensionOral	Zydus Lifesciences Limited	70771-1908	70771-1908-08
Bosentan	Bosentan 32 mg/1	Tablet, For suspensionOral	Lupin Pharmaceuticals, Inc.	68180-340	68180-0340-13
bosentan	Bosentan 62.5 mg/1	Tablet, Film coatedOral	Actavis Pharma, Inc.	0591-2511	00591-2511-60
bosentan	Bosentan 125 mg/1	Tablet, Film coatedOral	Actavis Pharma, Inc.	0591-2512	00591-2512-60
Bosentan	Bosentan 62.5 mg/1	Tablet, CoatedOral	Zydus Pharmaceuticals USA Inc.	68382-446	68382-0446-0168382-0446-0568382-0446-14+2 more
Bosentan	Bosentan 125 mg/1	Tablet, CoatedOral	Zydus Pharmaceuticals USA Inc.	68382-447	68382-0447-0168382-0447-0568382-0447-14+2 more
Bosentan	Bosentan 62.5 mg/1	TabletOral	Zydus Lifesciences Limited	70771-1017	70771-1017-0170771-1017-0470771-1017-05+2 more
Bosentan	Bosentan 62.5 mg/1	Tablet, Film coatedOral	Sun Pharmaceutical Industries, Inc.	47335-038	47335-0038-6447335-0038-86
Bosentan	Bosentan 125 mg/1	Tablet, Film coatedOral	Sun Pharmaceutical Industries, Inc.	47335-039	47335-0039-6447335-0039-86

Other NDCs under ANDA 207760

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

FDA NDC Directory listings under ANDA 207760
Product	Strength	Form · route	Labeler	Product NDC
Bosentan	Bosentan 62.5 mg/1	Tablet, CoatedOral	Zydus Pharmaceuticals USA Inc.	68382-446
Bosentan	Bosentan 125 mg/1	Tablet, CoatedOral	Zydus Pharmaceuticals USA Inc.	68382-447
Bosentan	Bosentan 62.5 mg/1	TabletOral	Zydus Lifesciences Limited	70771-1017