Prescription drug · UNAPPROVED DRUG OTHER
Esterified Estrogens And Methyltestosterone NDC 69315-283
esterified estrogens, methyltestosterone · Estrogens, Esterified .625 mg/1; Methyltestosterone 1.25 mg/1 · Tablet · Oral · Leading Pharmaceuticals, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69315-283-01 | 69315028301 | 100 TABLET in 1 BOTTLE (69315-283-01)Marketed from Oct 1, 2022 |
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)
- Esterified Estrogens And Methyltestosterone
- Generic name (nonproprietary)
- esterified estrogens, methyltestosterone
- Active ingredients
- Estrogens, Esterified — .625 mg/1Methyltestosterone — 1.25 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Leading Pharmaceuticals, LLC
- 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 69315-283_b0329bda-d477-4eed-815c-1049532e1bb0SPL ID b0329bda-d477-4eed-815c-1049532e1bb0SPL set ID 823629b9-cfb3-486b-b9aa-8efcfff67f67RxCUI 197670, 238006UNII 3ASP8Q3768, V9EFU16ZIFUPC 0369315284018, 0369315283011
- 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
N469315028301followed by a unit qualifier and the quantityPackage 69315-0283-01. 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 ESTERIFIED ESTROGENS AND METHYLTESTOSTERONE FULL STRENGTH and ESTERIFIED ESTROGENS AND METHYLTESTOSTERONE HALF STRENGTH 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.) ESTERIFIED ESTROGENS AND METHYLTESTOSTERONE FULL STRENGTH and ESTERIFIED ESTROGENS AND METHYLTESTOSTERONE HALF STRENGTH HAVE NOT BEEN SHOWN TO BE EFFECTIVE FOR ANY PURPOSE DURING PREGNANCY AND ITS USE MAY CAUSE SEVERE HARM T…
Excerpt only. Read the full label for complete information.