Prescription drug · NDA
Delestrogen (estradiol valerate) NDC 42023-111
Estradiol valerate 20 mg/mL · Injection · Intramuscular · Par Health USA, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 42023-111-01 | 42023011101 | 5 mL in 1 VIAL, MULTI-DOSE (42023-111-01)Marketed from Nov 1, 2007 |
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)
- Delestrogen
- Generic name (nonproprietary)
- estradiol valerate
- Active ingredients
- Estradiol valerate — 20 mg/mL
- Dosage form
- Injection
- Route
- Intramuscular
- Labeler
- Par Health USA, LLC
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 009402
- Marketing start
- Listing expires
- Other FDA classes
- Estradiol Congeners (Chemical structure)Estrogen Receptor Agonists (Mechanism)
- Identifiers
- Product ID 42023-111_58569bae-90e9-492c-a026-9a7b8797b3b4SPL ID 58569bae-90e9-492c-a026-9a7b8797b3b4SPL set ID e8f94df9-0692-4462-a7f0-fe019a0a3f07RxCUI 206620, 206715, 310189, 310190UNII 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
N442023011101followed by a unit qualifier and the quantityPackage 42023-0111-01. 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 . This label includes a boxed warning.
Indications (excerpt from the label)
INDICATIONS AND USAGE DELESTROGEN (estradiol valerate injection, USP) 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.
Other NDCs under NDA 009402
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 |
|---|---|---|---|---|
| Delestrogenestradiol valerate | Estradiol valerate 10 mg/mL | InjectionIntramuscular | Par Health USA, LLC | 42023-110 |