Prescription drug · UNAPPROVED DRUG OTHER
Esterified Estrogens and Methyltestosterone (Esterified estrogens, methyltestosterone) NDC 84346-450
Estrogens, Esterified .625 mg/1; Methyltestosterone 1.25 mg/1 · Tablet · Oral · STATUS PROJECTS PRIVATE LIMITED
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 84346-450-01 | 8434604500184346045001 | 100 TABLET in 1 BOTTLE (84346-450-01)Marketed from Apr 20, 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)
- 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
- STATUS PROJECTS PRIVATE LIMITEDNDC labeler code 84346
- 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 84346-450_df296524-e3fe-45f7-b653-2f9a0b0efd9aSPL ID df296524-e3fe-45f7-b653-2f9a0b0efd9aSPL set ID 289c9515-f17a-4d53-9230-d3aede01bf54RxCUI 238006UNII 3ASP8Q3768, V9EFU16ZIFUPC 0860015287007
- 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
N484346045001followed by a unit qualifier and the quantityPackage 84346-0450-01. 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)
5- Indication 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 HALF STRENGTH 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 84346-450
- What is NDC 84346-450?
- 84346-450 is the product NDC for Esterified Estrogens and Methyltestosterone, Estrogens, Esterified .625 mg/1; Methyltestosterone 1.25 mg/1 tablet, listed with the FDA by STATUS PROJECTS PRIVATE LIMITED. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Esterified Estrogens and Methyltestosterone (Esterified Estrogens, Methyltestosterone).
- What is the active ingredient?
- Estrogens, Esterified, Methyltestosterone.
- Who is the labeler?
- STATUS PROJECTS PRIVATE LIMITED, NDC labeler code 84346. 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 .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 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 | 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 | 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 .625 mg/1; Methyltestosterone 1.25 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-9178 | 63629-9178-01 |
| Esterified Estrogens and Methyltestosterone | Estrogens, Esterified 1.25 mg/1; Methyltestosterone 2.5 mg/1 | TabletOral | ANI Pharmaceuticals, Inc. | 62559-149 | 62559-0149-01 |
| Esterified Estrogens and Methyltestosterone | Estrogens, Esterified .625 mg/1; Methyltestosterone 1.25 mg/1 | TabletOral | ANI Pharmaceuticals, Inc. | 62559-150 | 62559-0150-01 |