What is NDC 0517-0440?

0517-0440 is the product NDC for Estradiol Valerate, Estradiol valerate 40 mg/mL injection, solution, listed with the FDA by American Regent, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

American Regent, Inc., NDC labeler code 0517. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Estradiol Valerate?

7 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Estradiol Valerate NDC 0517-0440 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)0517-0440Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00517-0440Add 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	Copy
0517-0440-01	00517044001	1 VIAL, MULTI-DOSE in 1 CARTON (0517-0440-01) / 5 mL in 1 VIAL, MULTI-DOSEMarketed from Mar 1, 2020

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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): Estradiol Valerate
Generic name (nonproprietary): estradiol valerate
Active ingredients: Estradiol valerate — 40 mg/mL
Dosage form: Injection, Solution
Route: Intramuscular
Labeler: American Regent, Inc.NDC labeler code 0517
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 090920
Marketing start: Mar 1, 2020
Listing expires: Dec 31, 2026
Other FDA classes: Estradiol Congeners (Chemical structure)Estrogen Receptor Agonists (Mechanism)
Identifiers: Product ID 0517-0440_abfdb011-4fe4-4c0f-b2df-77398b47738fSPL ID abfdb011-4fe4-4c0f-b2df-77398b47738fSPL set ID 2984bce2-89bf-4768-a1ca-ccf03b1197beRxCUI 310190, 310191UNII OKG364O896
Pharmacologic class: Estrogen

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

N400517044001 followed by a unit qualifier and the quantity

Package 00517-0440-01. 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 Oct 25, 2024. This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE Estradiol Valerate Injection is indicated in the: 1. Treatment of moderate to severe vasomotor symptoms associated with the menopause. 2. Treatment of moderate to severe symptoms of vulvar and vaginal atrophy associated with the menopause. When prescribing solely for the treatment of symptoms of vulvar and vaginal atrophy, topical vaginal products should be considered. 3. Treatment of hypoestrogenism due to hypogonadism, castration or primary ovarian failure. 4. Treatment of advanced androgen-dependent carcinoma of the prostate (for palliation only).

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0517-0440

What is NDC 0517-0440?: 0517-0440 is the product NDC for Estradiol Valerate, Estradiol valerate 40 mg/mL injection, solution, listed with the FDA by American Regent, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Estradiol Valerate.
What is the active ingredient?: Estradiol valerate.
Who is the labeler?: American Regent, Inc., NDC labeler code 0517. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Estradiol Valerate?: 7 other product NDCs are listed under this name. See all Estradiol Valerate 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 Estradiol Valerate NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Estradiol valerate	Estradiol valerate 20 mg/mL	InjectionIntramuscular	Xiromed, LLC	70700-274	70700-0274-22
Estradiol valerate	Estradiol valerate 10 mg/mL	InjectionIntramuscular	Xiromed, LLC	70700-273	70700-0273-22
Estradiol valerate	Estradiol valerate 40 mg/mL	InjectionIntramuscular	Xiromed, LLC	70700-275	70700-0275-22
Estradiol Valerate	Estradiol valerate 10 mg/mL	InjectionIntramuscular	Hikma Pharmaceuticals USA Inc.	0143-9289	00143-9289-01
Estradiol Valerate	Estradiol valerate 20 mg/mL	InjectionIntramuscular	Hikma Pharmaceuticals USA Inc.	0143-9290	00143-9290-01
Estradiol Valerate	Estradiol valerate 40 mg/mL	InjectionIntramuscular	Hikma Pharmaceuticals USA Inc.	0143-9291	00143-9291-01
Estradiol Valerate	Estradiol valerate 20 mg/mL	Injection, SolutionIntramuscular	American Regent, Inc.	0517-0420	00517-0420-01

Other NDCs under ANDA 090920

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

FDA NDC Directory listings under ANDA 090920
Product	Strength	Form · route	Labeler	Product NDC
Estradiol Valerate	Estradiol valerate 20 mg/mL	Injection, SolutionIntramuscular	American Regent, Inc.	0517-0420