NDC codes

FDA NDC Directory
Product NDC (as listed)25021-471Labeler and product segments. Claims need a package NDC.
Product NDC at billing width25021-0471Add 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 NDC11-digit (billing)PackageCopy
25021-471-6625021047166250210471662 SYRINGE in 1 CARTON (25021-471-66) / 5 mL in 1 SYRINGEMarketed from Apr 15, 2026

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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)
fulvestrant
Generic name (nonproprietary)
fulvestrant
Active ingredients
Fulvestrant — 50 mg/mL
Dosage form
Injection, Solution
Route
Intramuscular
Labeler
Sagent PharmaceuticalsNDC labeler code 25021
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 211422
Marketing start
Listing expires
Other FDA classes
Estrogen Receptor Antagonists (Mechanism)Selective Estrogen Receptor Modulators (Mechanism)
Identifiers
Product ID 25021-471_c42819d9-59df-44fa-aa7a-e510311dbbb8SPL ID c42819d9-59df-44fa-aa7a-e510311dbbb8SPL set ID d5ae9e07-73b0-4063-a9e4-0ffc5614c2b8RxCUI 727762UNII 22X328QOC4
Pharmacologic class
Estrogen 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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.

Administration

Drug administration (CPT 96360–96549)

When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.

How CPT relates to drug billing

NDC on a medical claim

N425021047166 followed by a unit qualifier and the quantity

Package 25021-0471-66. 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 .

Indications (excerpt from the label)

Fulvestrant injection is an estrogen receptor antagonist indicated for the treatment of: Hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer in postmenopausal women not previously treated with endocrine therapy. ( 1 ) HR-positive advanced breast cancer in postmenopausal women with disease progression following endocrine therapy. ( 1 ) HR-positive, HER2-negative advanced or metastatic breast cancer in postmenopausal women in combination with ribociclib, as initial endocrine based therapy or following disease progression on endocrine therapy. ( 1 ) HR-positive, HER2-negative advanced or metastatic breast cancer in combination with pal…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 25021-471

What is NDC 25021-471?
25021-471 is the product NDC for fulvestrant, Fulvestrant 50 mg/mL injection, solution, listed with the FDA by Sagent Pharmaceuticals. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
fulvestrant.
What is the active ingredient?
Fulvestrant.
Who is the labeler?
Sagent Pharmaceuticals, NDC labeler code 25021. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for fulvestrant?
20 other product NDCs are listed under this name. See all fulvestrant 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 fulvestrant NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
FulvestrantFulvestrant 50 mg/mLInjectionIntramuscularBluePoint Laboratories.68001-62668001-0626-85
FulvestrantFulvestrant 50 mg/mLInjection, SolutionIntramuscularAvenacy, Inc.83634-20383634-0203-74
FulvestrantFulvestrant 50 mg/mLInjection, SolutionIntramuscularDr.Reddy's Laboratories Inc43598-26243598-0262-23
FulvestrantFulvestrant 50 mg/mLInjectionIntramuscularSandoz Inc0781-353200781-3532-12
FulvestrantFulvestrant 50 mg/mLInjectionIntramuscularSandoz Inc0781-905500781-9055-12
FulvestrantFulvestrant 50 mg/mLInjectionIntravenousEugia US LLC55150-39455150-0394-02
FulvestrantFulvestrant 50 mg/mLInjectionIntramuscularAlembic Pharmaceuticals Inc.62332-65062332-0650-10
FulvestrantFulvestrant 50 mg/mLInjectionIntramuscularHikma Pharmaceuticals USA Inc.0143-902200143-9022-02
FulvestrantFulvestrant 50 mg/mLInjection, SolutionIntramuscularZydus Pharmaceuticals USA Inc.70710-168870710-1688-08
FulvestrantFulvestrant 50 mg/mLInjection, SolutionIntramuscularZydus Lifesciences Limited70771-162670771-1626-08

All 21 fulvestrant NDCs

Other NDCs under ANDA 211422

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

FDA NDC Directory listings under ANDA 211422
ProductStrengthForm · routeLabelerProduct NDC
FulvestrantFulvestrant 50 mg/mLInjection, SolutionIntramuscularAthenex Pharmaceutical Division, LLC.70860-211
FulvestrantFulvestrant 50 mg/mLInjectionIntramuscularChia Tai Tianqing Pharmaceutical Group Co., Ltd.71731-6121
FulvestrantFulvestrant 50 mg/mLInjection, SolutionIntramuscularAvenacy, Inc.83634-203

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