Prescription drug · ANDA
Estradiol valerate NDC 70700-273
Estradiol valerate 10 mg/mL · Injection · Intramuscular · Xiromed, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70700-273-22 | 70700027322 | 5 mL in 1 VIAL, MULTI-DOSE (70700-273-22)Marketed from May 1, 2023 |
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)
- Estradiol valerate
- Generic name (nonproprietary)
- estradiol valerate
- Active ingredients
- Estradiol valerate — 10 mg/mL
- Dosage form
- Injection
- Route
- Intramuscular
- Labeler
- Xiromed, LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 216656
- Marketing start
- Listing expires
- Other FDA classes
- Estradiol Congeners (Chemical structure)Estrogen Receptor Agonists (Mechanism)
- Identifiers
- Product ID 70700-273_55f31479-e1dc-2169-e063-6294a90a8817SPL ID 55f31479-e1dc-2169-e063-6294a90a8817SPL set ID 2e5c7559-7420-168d-6272-92bb4d20035dRxCUI 310189, 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.
- NDC on a medical claim
N470700027322followed by a unit qualifier and the quantityPackage 70700-0273-22. 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 . This label includes a boxed warning.
Indications (excerpt from the label)
INDICATIONS AND USAGE Estradiol valerate injection, USP is indicated in the: Treatment of moderate to severe vasomotor symptoms associated with the menopause. 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. Treatment of hypoestrogenism due to hypogonadism, castration or primary ovarian failure. Treatment of advanced androgen-dependent carcinoma of the prostate (for palliation only).
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 216656
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Estradiol valerate | Estradiol valerate 20 mg/mL | InjectionIntramuscular | Xiromed, LLC | 70700-274 |
| Estradiol valerate | Estradiol valerate 40 mg/mL | InjectionIntramuscular | Xiromed, LLC | 70700-275 |