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FULVESTRANT 50 mg/mL Injection, Solution — NDC 70771-1626-08 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

FULVESTRANT 50 mg/mL Injection, Solution — NDC 70771-1626-8 (Billing 70771-1626-08)

by Zydus Lifesciences Limited · 2 SYRINGE, GLASS in 1 CARTON / 5 mL in 1 SYRINGE, GLASS

This is a package of FULVESTRANT 50 mg/mL Injection, Solution from Zydus Lifesciences Limited, marketed since Dec 2021 and currently FDA-listed. It is this product's only package size.

NDC 70771-1626-08
🏷️ FDA NDC (as labeled) 70771-1626-8 billing pads the package segment with a zero
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 70771-1626-8 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
70771 labeler · 1626 product · 8 package
Package marketed since
Dec 14, 2021
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 7077116268 0
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 70771-1626-8
Product NDC 70771-1626
11-digit billing NDC 70771162608
RxCUI 727762
UNII 22X328QOC4
Application # ANDA215234
SPL Set ID 151b948a-3106-497a-b1c7-479307faeb89
Established class (EPC) Estrogen Receptor Antagonist
Mechanism of action Estrogen Receptor Antagonists; Selective Estrogen Receptor Modulators
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2021-12-14
Route INTRAMUSCULAR
Dosage form INJECTION, SOLUTION
Substance FULVESTRANT
TE code (Orange Book) AO · RLD · RS
Quick answers
  • RxCUI (RxNorm): 727762
Why two NDCs? The FDA registers this code as 70771-1626-8 — 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 → 70771-1626-08. 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 Estrogen Receptor Antagonist class.

Pharmacologic class Estrogen Receptor Antagonist
Drug family (ATC) Anti-estrogens
How it works Estrogen Receptor Antagonists, Selective Estrogen Receptor Modulators
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

📖 What it is MedlinePlus · NLM

Fulvestrant injection is used alone or in combination with another chemotherapy medication to treat a certain type of hormone receptor positive, advanced breast cancer (breast cancer that depends on hormones such as estrogen to grow) or breast cancer has spread to other parts of the body in women who have experienced menopause (change of life; end of monthly menstrual periods) and have not previously been treated with an anti-estrogen medication such as tamoxifen (Nolvadex). Fulvestrant injection is also used alone or in combination with certain other chemotherapy medications to treat a certai...

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • It treats HR-positive advanced or metastatic breast cancer, mainly in postmenopausal women. It can be used alone or with palbociclib, abemaciclib or ribociclib, depending on your s...
  • A healthcare professional injects it into the muscle of your buttocks, slowly over 1 to 2 minutes. You get doses closely spaced in the first month, then about once a month. Your cl...
  • The most common are pain where you were injected, nausea, bone or joint pain, headache, tiredness and hot flashes. Most are manageable, but tell your care team if they bother you....
  • The label lists no known drug interactions, and common enzyme-affecting drugs did not change its levels. Still, tell us about everything you take, especially blood thinners, becaus...
📖 Read our full Fulvestrant guide →

Supplement & herbal interactions

Some supplements/herbs that may interact with Fulvestrant — tap one for details:

DheaModerate
🌿 Every supplement checked against Fulvestrant (1 interactions) — ranked by severity →
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 mLPer 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 · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
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
70771-1626-08 You're viewing this Main listing 2 SYRINGE, GLASS in 1 CARTON / 5 mL in 1 SYRINGE, GLASS 2021-12-14 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Fulvestrant 50 mg/mL 00143-9022-02 Hikma 2 syringes — AO FDA listed —
Faslodex 50 mg/mL 00310-0720-10 AstraZeneca 2 syringes — AO FDA listed —
Fulvestrant 50 mg/mL 00781-3532-12 Sandoz 2 syringes — AO FDA listed —
Fulvestrant 50 mg/mL 00781-9055-12 Sandoz 2 syringes — AO FDA listed —
Fulvestrant 50 mg/mL 16714-0070-02 Northstar 2 syringes — AO FDA listed —
Fulvestrant 250 mg/5mL 16729-0436-30 Accord 2 syringes — AO FDA listed —
fulvestrant 50 mg/mL 25021-0471-74 Sagent 2 syringes — AO FDA listed —
Fulvestrant 50 mg/mL 43598-0262-02 Dr.Reddy's 2 syringes — AO Discontinued —
Fulvestrant 50 mg/mL 55150-0394-02 Eugia 2 syringes — — FDA listed —
Fulvestrant 50 mg/mL 62332-0650-05 Alembic 2 syringes — AO FDA listed —
Fulvestrant 50 mg/mL 63323-0715-05 Fresenius 2 syringes — AO FDA listed —
Fulvestrant 250 mg/5mL 68001-0484-85 BluePoint 2 syringes — AO FDA listed —
Fulvestrant 250 mg/5mL 68001-0522-85 BluePoint 2 syringes — AO FDA listed —
Fulvestrant 50 mg/mL 68001-0626-85 BluePoint 2 syringes — AO FDA listed —
Fulvestrant 50 mg/mL 68462-0317-32 GLENMARK 2 syringes — AO FDA listed —
Fulvestrant 250 mg/5mL 70121-1463-02 Amneal 2 syringes — AO FDA listed —
Fulvestrant 50 mg/mL 70700-0284-98 Xiromed, 2 syringes — AO FDA listed —
Fulvestrant 50 mg/mL 70710-1688-08 Zydus 2 syringes — AO FDA listed —
Fulvestrant 50 mg/mLthis 70771-1626-08 Zydus 2 syringes — AO FDA listed —
Fulvestrant 50 mg/mL 70860-0211-74 Athenex 2 syringes — AO FDA listed —
Fulvestrant 50 mg/mL 71288-0555-86 Meitheal 2 syringes — AO FDA listed —
Fulvestrant 50 mg/mL 71731-6121-01 Chia 2 syringes — AO FDA listed —
Fulvestrant 50 mg/mL 83634-0203-74 Avenacy, 2 syringes — AO FDA listed —
Cligavyx 250 mg/5mL 83831-0159-02 Avyxa 2 syringes — — 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

🏛️
2021
On the market since
Dec 2021
📍
2026
Currently FDA-listed
5 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.

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.

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

  • UNII 3K9958V90M
    A liquid solvent derived from fermentation or chemical synthesis. In medicines, alcohol dissolves active ingredients, helps preserve the product, and improves how the body absorbs certain drugs.
  • UNII LKG8494WBH
    Benzyl alcohol is a clear liquid used as a preservative and solvent in medicines. It helps prevent bacterial and fungal growth and dissolves other ingredients to create uniform liquid formulations.
  • UNII N863NB338G
    Benzyl benzoate is a liquid organic compound used as a solvent and preservative in medicines. It helps dissolve active ingredients and can extend shelf life by preventing microbial growth in liquid formulations.
  • UNII D5340Y2I9G
    Castor oil is a natural plant-based oil used in medicines as a lubricant, laxative agent, and solvent. It helps medicine ingredients dissolve or flow smoothly and can aid bowel movement in formulations designed for that purpose.

4 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 applicationANDA215234 (ANDA)
Labeler code70771
First marketedDec 2021
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.
📄 Package Label / Principal Display Panel
📄 Package Label / Principal Display Panel 130 words ▾

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 70771-1626-2 Fulvestrant Injection 250 mg/5 mL (50 mg/mL) For Intramuscular Use Only Both single-dose prefilled syringes must be administered to receive the 500 mg dose. PROTECT FROM LIGHT Rx only Made in India NDC 70771-1626-8 Fulvestrant Injection 250 mg/5 mL (50 mg/mL) For Intramuscular Use Only This carton contains a total of 500 mg fulvestrant in TWO single-dose prefilled syringes each containing 250 mg/5 mL, and two Safety Glide™ shielding intramuscular injection needles.

Discard each syringe after use. Both single-dose prefilled syringes must be administered to receive the 500 mg dose. STORAGE: REFRIGERATE 2° to 8°C (36° to 46°F).

TO PROTECT FROM LIGHT, STORE IN THE ORIGINAL CARTON UNTIL TIME OF USE. Contains 2 Single-Dose Prefilled Syringes Rx only pfs mfg label carton mfg 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 Fulvestrant — the program that covers self-administered drugs. 12 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 Fulvestrant. 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
$1.52M
Claims incl. refills
3K
Beneficiaries
1.2K
Spend / beneficiary
$1,249.91
Spend / claim
$511.48
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.
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.
← 70771-1625-07 · Zydus 70771-1627-03 · 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.