Prescription drug · ANDA
Estradiol Valerate NDC 0143-9290
Estradiol valerate 20 mg/mL · Injection · Intramuscular · Hikma Pharmaceuticals USA Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0143-9290-01 | 00143929001 | 1 VIAL in 1 CARTON (0143-9290-01) / 5 mL in 1 VIALMarketed from Apr 21, 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 — 20 mg/mL
- Dosage form
- Injection
- Route
- Intramuscular
- Labeler
- Hikma Pharmaceuticals USA Inc.NDC labeler code 0143
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 203723
- Marketing start
- Listing expires
- Other FDA classes
- Estradiol Congeners (Chemical structure)Estrogen Receptor Agonists (Mechanism)
- Identifiers
- Product ID 0143-9290_5fa9d3b5-6bfd-40e9-900e-21427f6c4d21SPL ID 5fa9d3b5-6bfd-40e9-900e-21427f6c4d21SPL set ID 66f40ab0-4432-4e85-b709-a0bc076868c6RxCUI 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
N400143929001followed by a unit qualifier and the quantityPackage 00143-9290-01. 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 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.
About NDC 0143-9290
- What is NDC 0143-9290?
- 0143-9290 is the product NDC for Estradiol Valerate, Estradiol valerate 20 mg/mL injection, listed with the FDA by Hikma Pharmaceuticals USA 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?
- Hikma Pharmaceuticals USA Inc., NDC labeler code 0143. 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.
Related NDCs: other Estradiol Valerate products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Estradiol valerate | Estradiol valerate 10 mg/mL | InjectionIntramuscular | Xiromed, LLC | 70700-273 | 70700-0273-22 |
| Estradiol valerate | Estradiol valerate 20 mg/mL | InjectionIntramuscular | Xiromed, LLC | 70700-274 | 70700-0274-22 |
| 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 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 |
| Estradiol Valerate | Estradiol valerate 40 mg/mL | Injection, SolutionIntramuscular | American Regent, Inc. | 0517-0440 | 00517-0440-01 |
Other NDCs under ANDA 203723
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 40 mg/mL | InjectionIntramuscular | Hikma Pharmaceuticals USA Inc. | 0143-9291 |
| Estradiol Valerate | Estradiol valerate 10 mg/mL | InjectionIntramuscular | Hikma Pharmaceuticals USA Inc. | 0143-9289 |