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Fulvestrant 50 mg/mL Injection, Solution — NDC 43598-262-23 (Billing 43598-0262-23)

by Dr.Reddy's Laboratories Inc · 2 SYRINGE, GLASS in 1 CARTON / 5 mL in 1 SYRINGE, GLASS

This is a package of Fulvestrant 50 mg/mL Injection, Solution from Dr.Reddy's Laboratories Inc, marketed since Dec 2023 and currently FDA-listed. It is the main listing for this product, which comes in 2 package sizes.

NDC 43598-0262-23
🏷️ FDA NDC (as labeled) 43598-262-23 billing pads the product segment with a zero
This package
Contains5 mL in 1 syringe, glass Medicaid pays$22.90 / unit · 12 mo Per package$228.98 / 10 ml · Medicaid Pack sizes2 compare ↓
Main listing for product 43598-262 · Also comes in: 2 syringes 43598-262-02
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 2026 · this listing last changed Oct 8, 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 43598-262-23 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
43598 labeler · 262 product · 23 package
Package marketed since
Sep 5, 2024
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC-A, from the NDC)
3 4359826223 9
Medicaid fills, this package
441 prescriptions in the last four reported quarters
FDA record last changed
Oct 8, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 43598-262-23
Product NDC 43598-262
11-digit billing NDC 43598026223
NCPDP billing unit ML — per mL (volume)
Application # ANDA209246
SPL Set ID 711b8216-a850-2e78-bdb1-68c98787e8e5
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 2023-12-31
Route INTRAMUSCULAR
Dosage form INJECTION, SOLUTION
Substance FULVESTRANT
TE code (Orange Book) AO · RLD · RS

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GCN Seq No 050307
GCN 17307
HICL code 023523
Ingredient (HICL) Fulvestrant
HIC1 code V
Therapeutic class — broad (HIC1) Neoplasms
HIC2 code V1
Therapeutic class — intermediate (HIC2) Antineoplastic Drugs
HIC3 code V1T
Therapeutic class — specific (HIC3) Selective Estrogen Receptor Modulators (Serms)
AHFS code 10:00.00.00
AHFS class Antineoplastic Agents
FDB label name FULVESTRANT 250 MG/5 ML SYRING
FDB brand name Fulvestrant
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 050307
  • GCN: 17307
  • HICL (First Databank): 023523
  • AHFS class code: 10:00.00.00
Why two NDCs? The FDA registers this code as 43598-262-23 — a 5-3-2 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 product segment → 43598-0262-23. 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.

Clinical

Label name FULVESTRANT 250 MG/5 ML SYRING Ingredient Fulvestrant
📖 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 $22.90 $228.98 / 10 ml
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
Medicare Part B allowsASP · J9395 $5.277 / J9395 unit —
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.

Billing & reimbursement

FDA NDC (as labeled)43598-262-23
11-digit billing NDC43598-0262-23
Format5-3-2 as registered → padded to 5-4-2 for billing (zero added to the product segment)
HCPCS J-codeJ9395
DescriptorInjection, fulvestrant, 25 mg
Billing units / pkg20 units
How the units are derivedThis package is 5; the HCPCS unit is 25 MG, so one package = 20 billing units.
Medicare Part B spend (2026 (Q1))$1,319,236 · 12,034 claims · $109.63 per claim (all NDCs under J9395)
Crosswalk sourceCMS ASP NDC-HCPCS Crosswalk
Where does this data come from?
The HCPCS J-code crosswalk comes from the CMS ASP NDC-HCPCS crosswalk and the DMEPDAC (DME MAC) NDC-HCPCS crosswalk — free public CMS data. Billing units are derived from the code’s descriptor and the package amount.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
43598-0262-02 43598-262-02 2 SYRINGE, GLASS in 1 CARTON / 5 mL in 1 SYRINGE, GLASS 2020-08-17 — Discontinued by firm
43598-0262-23 You're viewing this Main listing 2 SYRINGE, GLASS in 1 CARTON / 5 mL in 1 SYRINGE, GLASS 2024-09-05 — Active

In Medicaid, this is the most-dispensed pack of this product — about 85% of fills over the last four reported quarters. See all packs ↓

Pack size FAQ

What quantity is in this package?
This package is listed by the FDA — 2 syringe, glass in 1 carton / 5 ml in 1 syringe, glass.
What NDC number is used to bill for this package of Fulvestrant 50 mg/mL Injection, Solution?
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
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/mLthis 43598-0262-23 Dr.Reddy's 2 syringes — AO FDA listed —
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/mL 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

🏛️
2023
On the market since
Dec 2023
📍
2026
Currently FDA-listed
3 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.

🧪 Avoiding an ingredient? See Fulvestrant 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.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

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

LabelerDr.Reddy's Laboratories Inc
Application holderDR REDDYS LABORATORIES LTD
FDA applicationANDA209246 (ANDA)
Labeler code43598
First marketedDec 2023
Product typeHuman Prescription Drug
Portfolio30 products on file

More NDCs from Dr.Reddy's Laboratories Inc labeler code 43598

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.
📄 FDA label
📄 FDA label 19 words ▾

No FDA label is on file for this product yet. Labels load from openFDA / DailyMed and refresh weekly.

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

Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for this package alone, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q1 2026 · 5 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
441
Units reimbursed last 4 qtrs
4.5K
Gross reimbursed last 4 qtrs
$102.8K
Avg / prescription
$233.14
Avg / unit
$22.8984
Latest quarter Q1 2026
14Rx
Fee-for-service vs managed care ⓘ
33% FFS 67% MCO
Fee-for-service · 147 Rx Managed care · 294 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: 600 units · 10.2 per 100k residents WI Michigan: no data reported MI New York: 1,535 units · 7.8 per 100k residents NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: no data reported IL Indiana: no data reported IN Ohio: 480 units · 4.1 per 100k residents OH Pennsylvania: no data reported PA New Jersey: 505 units · 5.4 per 100k residents NJ Massachusetts: 210 units · 3.0 per 100k residents MA California: 110 units · 0.3 per 100k residents CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: no data reported MO Kentucky: no data reported KY West Virginia: no data reported WV Virginia: no data reported VA Maryland: no data reported MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: no data reported TN North Carolina: 180 units · 1.7 per 100k residents NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: no data reported TX Florida: 870 units · 3.8 per 100k residents FL
Units reimbursed · per 100k residents
0.310.2
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 Wisconsin 10.2 /100k
2 New York 7.8 /100k
3 New Jersey 5.4 /100k
4 Ohio 4.1 /100k
5 Florida 3.8 /100k
6 Massachusetts 3.0 /100k
7 North Carolina 1.7 /100k
8 California 0.3 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
2 syringes this page43598-0262-23 441 Rx · $102,814
2 syringes43598-0262-02 77 Rx · $10,383
Drug total (last 4 qtrs): 518 Rx · 5,255 units · $113,196 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

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 — Not published for this NDC No photo available yet for this listing.
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is 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 ✓ Available
Medicaid utilization (CMS SDUD) ✓ Available
“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 Dr.Reddy's Laboratories Inc. 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 1 other package presentation of this same product, including 2 syringes (43598-0262-02). 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?
Dr.Reddy's Laboratories Inc 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.
Does this product have a billing J-code?
Yes — this NDC cross-references HCPCS code J9395 for medical-claim billing (typically used when a product is administered in a clinical setting rather than dispensed at a retail pharmacy). See the Billing section on this page.
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.
← 43598-0259-40 · Dr. 43598-0265-25 · Dr. →
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.