Prescription drug · UNAPPROVED DRUG OTHER
Estratest H.S. (Esterified estrogens, methyltestosterone) NDC 58657-403
Estrogens, Esterified .625 mg/1; Methyltestosterone 1.25 mg/1 · Tablet · Oral · Method Pharmaceuticals, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 58657-403-01 | 5865704030158657040301 | 100 TABLET in 1 BOTTLE (58657-403-01)Marketed from Jun 15, 2024 |
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)
- Estratest H.S.
- Generic name (nonproprietary)
- esterified estrogens, methyltestosterone
- Active ingredients
- Estrogens, Esterified — .625 mg/1Methyltestosterone — 1.25 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Method Pharmaceuticals, LLCNDC labeler code 58657
- Product type
- Prescription drug
- Marketing category
- Unapproved drug (other)
- Marketing start
- Listing expires
- DEA schedule
- CIII
- Other FDA classes
- Androgen Receptor Agonists (Mechanism)Androstanes (Chemical structure)
- Identifiers
- Product ID 58657-403_41b4c56d-4bd6-f1cf-e063-6394a90a332dSPL ID 41b4c56d-4bd6-f1cf-e063-6394a90a332dSPL set ID 1ab6a396-b384-7958-e063-6394a90abfddRxCUI 197670, 209251, 209253, 238006UNII V9EFU16ZIF, 3ASP8Q3768UPC 0358657404017, 0358657403010
- Pharmacologic class
- Androgen
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 HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N458657040301followed by a unit qualifier and the quantityPackage 58657-0403-01. 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 ESTRATEST H.S. AND ESTRATEST F.S. are indicated in the treatment of: Moderate to severe vasomotor symptoms associated with the menopause in those patients not improved by estrogens alone. (There is no evidence that estrogens are effective for nervous symptoms or depression without associated vasomotor symptoms, and they should not be used to treat such conditions.) ESTRATEST H.S. AND ESTRATEST F.S. HAVE NOT BEEN SHOWN TO BE EFFECTIVE FOR ANY PURPOSE DURING PREGNANCY AND ITS USE MAY CAUSE SEVERE HARM TO THE FETUS (SEE BOXED WARNING ).
Excerpt only. Read the full label for complete information.
About NDC 58657-403
- What is NDC 58657-403?
- 58657-403 is the product NDC for Estratest H.S., Estrogens, Esterified .625 mg/1; Methyltestosterone 1.25 mg/1 tablet, listed with the FDA by Method Pharmaceuticals, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Estratest H.S. (Esterified estrogens, Methyltestosterone).
- What is the active ingredient?
- Estrogens, Esterified, Methyltestosterone.
- Who is the labeler?
- Method Pharmaceuticals, LLC, NDC labeler code 58657. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Estratest H.S.?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.