Prescription drug · UNAPPROVED DRUG OTHER
Esterified Estrogens and Methyltestosterone NDC 62559-149
Estrogens, Esterified 1.25 mg/1; Methyltestosterone 2.5 mg/1 · Tablet · Oral · ANI Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 62559-149-01 | 62559014901 | 100 TABLET in 1 BOTTLE (62559-149-01)Marketed from Dec 22, 2010 |
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 and methyltestosterone
- Active ingredients
- Estrogens, Esterified — 1.25 mg/1Methyltestosterone — 2.5 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- ANI Pharmaceuticals, Inc.NDC labeler code 62559
- 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 62559-149_027e7148-2471-49b5-9fea-88d7c2d7684cSPL ID 027e7148-2471-49b5-9fea-88d7c2d7684cSPL set ID d42eeda8-d810-4481-a403-6a3520b9e69aRxCUI 197670, 238006UNII V9EFU16ZIF, 3ASP8Q3768UPC 0362559149013, 0362559150019
- 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
N462559014901followed by a unit qualifier and the quantityPackage 62559-0149-01. 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 and Half-Strength Tablets 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 and Half-Strength Tablets have not been shown to be effective for any purpose during pregnancy and its use may cause severe harm to the fetus.
Excerpt only. Read the full label for complete information.
About NDC 62559-149
- What is NDC 62559-149?
- 62559-149 is the product NDC for Esterified Estrogens and Methyltestosterone, Estrogens, Esterified 1.25 mg/1; Methyltestosterone 2.5 mg/1 tablet, listed with the FDA by ANI Pharmaceuticals, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Esterified Estrogens and Methyltestosterone.
- What is the active ingredient?
- Estrogens, Esterified, Methyltestosterone.
- Who is the labeler?
- ANI Pharmaceuticals, Inc., NDC labeler code 62559. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Esterified Estrogens and Methyltestosterone?
- 17 other product NDCs are listed under this name. See all Esterified Estrogens and Methyltestosterone NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Esterified Estrogens and Methyltestosterone products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Esterified Estrogens And Methyltestosteroneesterified estrogens, methyltestosterone | Estrogens, Esterified 1.25 mg/1; Methyltestosterone 2.5 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-2393 | 72162-2393-01 |
| Esterified Estrogens And Methyltestosteroneesterified estrogens, methyltestosterone | Estrogens, Esterified .625 mg/1; Methyltestosterone 1.25 mg/1 | TabletOral | Method Pharmaceuticals, LLC | 58657-407 | 58657-0407-01 |
| Esterified Estrogens And Methyltestosteroneesterified estrogens, methyltestosterone | Estrogens, Esterified 1.25 mg/1; Methyltestosterone 2.5 mg/1 | TabletOral | Method Pharmaceuticals, LLC | 58657-408 | 58657-0408-01 |
| Esterified Estrogens and Methyltestosteroneesterified estrogens, methyltestosterone | Estrogens, Esterified .625 mg/1; Methyltestosterone 1.25 mg/1 | TabletOral | STATUS PROJECTS PRIVATE LIMITED | 84346-450 | 84346-0450-01 |
| Esterified Estrogens And Methyltestosteroneesterified estrogens, methyltestosterone | Estrogens, Esterified .625 mg/1; Methyltestosterone 1.25 mg/1 | TabletOral | Leading Pharmaceuticals, LLC | 69315-283 | 69315-0283-01 |
| Esterified Estrogens And Methyltestosteroneesterified estrogens, methyltestosterone | Estrogens, Esterified 1.25 mg/1; Methyltestosterone 2.5 mg/1 | TabletOral | Leading Pharmaceuticals, LLC | 69315-284 | 69315-0284-01 |
| Esterified Estrogens and Methyltestosterone | Estrogens, Esterified .625 mg/1; Methyltestosterone 1.25 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-9178 | 63629-9178-01 |
| Esterified Estrogens and Methyltestosterone | Estrogens, Esterified .625 mg/1; Methyltestosterone 1.25 mg/1 | TabletOral | ECI Pharmaceuticals LLC | 51293-639 | 51293-0639-01 |
| Esterified Estrogens and Methyltestosterone | Estrogens, Esterified 1.25 mg/1; Methyltestosterone 2.5 mg/1 | TabletOral | ECI Pharmaceuticals LLC | 51293-640 | 51293-0640-01 |
| Esterified Estrogens and Methyltestosterone | Estrogens, Esterified 1.25 mg/1; Methyltestosterone 2.5 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-1747 | 72162-1747-01 |