What is NDC 70771-1364?

70771-1364 is the product NDC for Ambrisentan, Ambrisentan 10 mg/1 tablet, film coated, 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 Ambrisentan?

22 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Ambrisentan NDC 70771-1364 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)70771-1364Labeler and product segments. Claims need a package NDC.

Product NDC at billing width70771-1364Add 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
70771-1364-1	7077113640170771136401	100 TABLET, FILM COATED in 1 BOTTLE (70771-1364-1)Marketed from Apr 12, 2019
70771-1364-3	7077113640370771136403	30 TABLET, FILM COATED in 1 BOTTLE (70771-1364-3)Marketed from Apr 12, 2019
70771-1364-7	7077113640770771136407	1 BLISTER PACK in 1 CARTON (70771-1364-7) / 10 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Apr 12, 2019
70771-1364-8	7077113640870771136408	3 BLISTER PACK in 1 CARTON (70771-1364-8) / 10 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Apr 12, 2019
70771-1364-9	7077113640970771136409	90 TABLET, FILM COATED in 1 BOTTLE (70771-1364-9)Marketed from Apr 12, 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): Ambrisentan
Generic name (nonproprietary): ambrisentan
Active ingredients: Ambrisentan — 10 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Zydus Lifesciences LimitedNDC labeler code 70771
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 210058
Marketing start: Apr 12, 2019
Listing expires: Dec 31, 2027
Other FDA classes: Endothelin Receptor Antagonists (Mechanism)
Identifiers: Product ID 70771-1364_14a85c38-61bf-4621-8e3a-34ab57a15758SPL ID 14a85c38-61bf-4621-8e3a-34ab57a15758SPL set ID 0e3e3320-27ac-404f-9f01-3d82696e768aRxCUI 722116, 722122UNII HW6NV07QEC
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

N470771136401 followed by a unit qualifier and the quantity

Package 70771-1364-01. 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 70771-1364

What is NDC 70771-1364?: 70771-1364 is the product NDC for Ambrisentan, Ambrisentan 10 mg/1 tablet, film coated, 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?: Ambrisentan.
What is the active ingredient?: Ambrisentan.
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 Ambrisentan?: 22 other product NDCs are listed under this name. See all Ambrisentan 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 Ambrisentan NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Ambrisentan	Ambrisentan 5 mg/1	Tablet, Film coatedOral	Quallent Pharmaceuticals Health LLC	82009-141	82009-0141-30
Ambrisentan	Ambrisentan 10 mg/1	Tablet, Film coatedOral	Quallent Pharmaceuticals Health LLC	82009-142	82009-0142-30
Ambrisentan	Ambrisentan 5 mg/1	Tablet, Film coatedOral	Apotex Corp.	60505-4552	60505-4552-03
Ambrisentan	Ambrisentan 10 mg/1	Tablet, Film coatedOral	Apotex Corp.	60505-4553	60505-4553-03
ambrisentan	Ambrisentan 10 mg/1	Tablet, Film coatedOral	A-S Medication Solutions	50090-7670	50090-7670-00
ambrisentan	Ambrisentan 5 mg/1	Tablet, Film coatedOral	A-S Medication Solutions	50090-7671	50090-7671-00
ambrisentan	Ambrisentan 5 mg/1	Tablet, Film coatedOral	Aurobindo Pharma Limited	59651-494	59651-0494-30
ambrisentan	Ambrisentan 10 mg/1	Tablet, Film coatedOral	Aurobindo Pharma Limited	59651-495	59651-0495-30
Ambrisentan	Ambrisentan 5 mg/1	Tablet, Film coatedOral	Golden State Medical Supply, Inc.	51407-594	51407-0594-30
Ambrisentan	Ambrisentan 10 mg/1	Tablet, Film coatedOral	Golden State Medical Supply, Inc.	51407-595	51407-0595-30

All 23 Ambrisentan NDCs

Other NDCs under ANDA 210058

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

FDA NDC Directory listings under ANDA 210058
Product	Strength	Form · route	Labeler	Product NDC
Ambrisentan	Ambrisentan 5 mg/1	Tablet, Film coatedOral	Zydus Pharmaceuticals USA Inc.	70710-1179
Ambrisentan	Ambrisentan 10 mg/1	Tablet, Film coatedOral	Zydus Pharmaceuticals USA Inc.	70710-1180
Ambrisentan	Ambrisentan 5 mg/1	Tablet, Film coatedOral	Zydus Lifesciences Limited	70771-1363
Ambrisentan	Ambrisentan 5 mg/1	Tablet, Film coatedOral	Quallent Pharmaceuticals Health LLC	82009-141
Ambrisentan	Ambrisentan 10 mg/1	Tablet, Film coatedOral	Quallent Pharmaceuticals Health LLC	82009-142