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Ambrisentan 5 mg Tablet, Film Coated — NDC 70771-1363-08 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Ambrisentan 5 mg Tablet, Film Coated — NDC 70771-1363-8 (Billing 70771-1363-08)

by Zydus Lifesciences Limited · 3 BLISTER PACK in 1 CARTON / 10 TABLET, FILM COATED in 1 BLISTER PACK

This is a package of Ambrisentan 5 mg Tablet, Film Coated from Zydus Lifesciences Limited, marketed since Apr 2019 and currently FDA-listed.

NDC 70771-1363-08
🏷️ FDA NDC (as labeled) 70771-1363-8 billing pads the package segment with a zero
This package
Contains10 tablet, film coated in 1 blister pack Pack sizes5 compare ↓
Also priced by: Part D plans $87.47/unit — full pricing hub ↓
Product page 70771-1363-01 Also comes in: 10 tablets 70771-1363-7 30 tablets 70771-1363-3 90 tablets 70771-1363-9 100 tablets 70771-1363-1
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

NDC database record

One package, one record: these facts belong to NDC 70771-1363-8 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
70771 labeler · 1363 product · 8 package
Package marketed since
Apr 12, 2019
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 7077113638 4
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 70771-1363-8
Product NDC 70771-1363
11-digit billing NDC 70771136308
RxCUI 722116, 722122
UNII HW6NV07QEC
Application # ANDA210058
SPL Set ID 0e3e3320-27ac-404f-9f01-3d82696e768a
Established class (EPC) Endothelin Receptor Antagonist
Mechanism of action Endothelin Receptor Antagonists
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2019-04-12
Route ORAL
Dosage form TABLET, FILM COATED
Substance AMBRISENTAN
TE code (Orange Book) AB · RLD · RS
Quick answers
  • RxCUI (RxNorm): 722116
Why two NDCs? The FDA registers this code as 70771-1363-8 — a 5-4-1 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the package segment → 70771-1363-08. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the Endothelin Receptor Antagonist class.

Pharmacologic class Endothelin Receptor Antagonist
Drug family (ATC) Antihypertensives for pulmonary arterial hypertension
How it works Endothelin Receptor Antagonists
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

📗 Our plain-language guide HelloPharmacist
  • Ambrisentan won't cure PAH, but it can make a real difference in how you feel and function. It works by blocking a protein called ET-1 that causes the blood vessels in your lungs t...
  • What exactly does ambrisentan do, and will it cure my PAH?
  • Good news — food doesn't affect how well your body absorbs ambrisentan, so you can take it with or without a meal, whichever works best for your routine. Pick a time of day you can...
  • Can I take ambrisentan with food, and does it matter what time of day I take it?
📖 Read our full Ambrisentan guide →
1
Nutrient depletion considerations

Ambrisentan may be associated with lower levels of 1 nutrient — worth a chat with your pharmacist, not a cause for alarm.

🧪 Full Ambrisentan nutrient depletion report →
An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · Q2 2026 $87.47 $2,624.22 / 30 tablets
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
70771-1363-01 70771-1363-1 Main listing 100 TABLET, FILM COATED in 1 BOTTLE 2019-04-12 — Active
70771-1363-03 70771-1363-3 30 TABLET, FILM COATED in 1 BOTTLE 2019-04-12 — Active
70771-1363-07 70771-1363-7 1 BLISTER PACK in 1 CARTON / 10 TABLET, FILM COATED in 1 BLISTER PACK 2019-04-12 — Active
70771-1363-08 You're viewing this 3 BLISTER PACK in 1 CARTON / 10 TABLET, FILM COATED in 1 BLISTER PACK 2019-04-12 — Active
70771-1363-09 70771-1363-9 90 TABLET, FILM COATED in 1 BOTTLE 2019-04-12 — Active

Pack size FAQ

What quantity is in this package?
This package is listed by the FDA — 3 blister pack in 1 carton / 10 tablet, film coated in 1 blister pack.
What NDC number is used to bill for this package of Ambrisentan 5 mg Tablet, Film Coated?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Ambrisentan 5 mg 00378-4270-93 Mylan 30 tablets — AB FDA listed —
Ambrisentan 5 mg 00591-2405-30 Actavis 30 tablets — AB FDA listed —
Ambrisentan 5 mg 42794-0051-08 Sigmapharm 30 tablets — AB FDA listed —
ambrisentan 5 mg 47335-0236-64 Sun 10 tablets — — FDA listed —
ambrisentan 5 mg 50090-7671-00 A-S 30 tablets — AB FDA listed —
Ambrisentan 5 mg 51407-0594-30 Golden 30 tablets — AB FDA listed —
ambrisentan 5 mg 59651-0494-30 Aurobindo 30 tablets — AB FDA listed —
Ambrisentan 5 mg 60505-4552-03 Apotex 30 tablets — AB FDA listed —
Letairis 5 mg 61958-0801-01 Gilead 30 tablets — AB FDA listed —
Ambrisentan 5 mg 69097-0386-02 Cipla 30 tablets — AB FDA listed —
Ambrisentan 5 mg 70710-1179-01 Zydus 100 tablets — AB FDA listed —
Ambrisentan 5 mgthis 70771-1363-08 Zydus 10 tablets — AB FDA listed —
Ambrisentan 5 mg 82009-0141-30 Quallent 30 tablets — AB FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2019
On the market since
Apr 2019
📍
2026
Currently FDA-listed
7 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

What it looks like

Color Pink / White
ShapeOval
Imprint1180
Size1 mm
ScoringNot scored
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

🧪 Avoiding an ingredient? See Ambrisentan inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII LMI26O6933
    Alumina is a white powder form of aluminum oxide. It's used as a filler to add bulk to tablets and capsules, and sometimes as a thickening or anti-caking agent in powdered formulations.
  • UNII OP1R32D61U
    Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
  • UNII M28OL1HH48
    Croscarmellose sodium is a plant-based substance derived from cellulose. It acts as a disintegrant, helping tablets and capsules break down quickly in the digestive system so the medicine can be absorbed.
  • UNII WZB9127XOA
    A synthetic red dye used to color medications and make them easier to identify. It serves as a colorant in tablets, capsules, and liquid formulations.
  • UNII EWQ57Q8I5X
    Lactose monohydrate is a natural sugar derived from milk. It serves as a filler and binder in tablets and capsules, helping create the proper size, texture, and consistency of the medicine.
  • UNII 1DI56QDM62
    A natural fatty substance from soybeans that helps mix oil and water-based ingredients together. It acts as an emulsifier and lubricant in medicines to improve texture and help the product break down properly in your body.
  • UNII 70097M6I30
    Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
  • UNII 3WJQ0SDW1A
    Polyethylene glycol is a synthetic liquid or solid polymer used in medicines as a solvent, lubricant, and humectant. It helps dissolve active ingredients, reduces friction during manufacturing, and retains moisture in the final product.
  • UNII 532B59J990
    Polyvinyl alcohol is a synthetic polymer made from plant-derived materials. It's used as a binder to hold ingredients together, a film-former in coatings, and a thickener in liquid formulations.
  • UNII FZ989GH94E
    Povidone is a synthetic polymer made from a plastic-like material. It acts as a binder to hold tablet ingredients together and as a disintegrant to help the tablet break apart in your stomach so the medicine can be absorbed.
  • UNII 7SEV7J4R1U
    A powder made from a naturally occurring mineral. In medicines, talc works as a glidant and anti-caking agent, helping tablets and capsules flow smoothly during manufacturing and preventing clumping.
  • UNII 15FIX9V2JP
    Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.

12 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerZydus Lifesciences Limited
Application holderZYDUS PHARMACEUTICALS USA INC
FDA applicationANDA210058 (ANDA)
Labeler code70771
First marketedApr 2019
Product typeHuman Prescription Drug
Portfolio720 products on file

More NDCs from Zydus Lifesciences Limited labeler code 70771

The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
💬 Medication Guide 📄 Package Label / Principal Display Panel
💬 Medication Guide 2 words ▾

SPL MEDGUIDE

📄 Package Label / Principal Display Panel 26 words ▾

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 70771-1363-3 Ambrisentan Tablets, 5 mg 30 Tablets Rx only NDC 70771-1364-3 Ambrisentan Tablets, 10 mg 30 Tablets Rx only labels label

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Ambrisentan — the program that covers self-administered drugs. 7 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Ambrisentan. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$27.85M
Claims incl. refills
15.9K
Beneficiaries
6.1K
Spend / beneficiary
$4,542.00
Spend / claim
$1,754.58
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Zydus Lifesciences Limited. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 4 other package presentations of this same product, including 10 tablets (70771-1363-07), 30 tablets (70771-1363-03), 90 tablets (70771-1363-09). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Zydus Lifesciences Limited is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 70771-1362-00 · Zydus 70771-1364-01 · Zydus →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.