Prescription drug · NDA
Duavee (Conjugated estrogens/bazedoxifene) NDC 63539-122
Estrogens, Conjugated .45 mg/1; Bazedoxifene acetate 20 mg/1 · Tablet, Film coated · Oral · U.S. Pharmaceuticals
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63539-122-07 | 6353901220763539012207 | 1 BLISTER PACK in 1 CARTON (63539-122-07) / 7 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Nov 15, 2013 · Sample package |
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)
- Duavee
- Generic name (nonproprietary)
- conjugated estrogens/bazedoxifene
- Active ingredients
- Estrogens, Conjugated — .45 mg/1Bazedoxifene acetate — 20 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- U.S. PharmaceuticalsNDC labeler code 63539
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 022247
- Marketing start
- Marketing end
- Other FDA classes
- Estrogen Receptor Agonists (Mechanism)Conjugated (USP) (Chemical structure)Selective Estrogen Receptor Modulators (Mechanism)
- Identifiers
- Product ID 63539-122_7e3443ae-8aa6-473c-923c-aac11d3b30e9SPL ID 7e3443ae-8aa6-473c-923c-aac11d3b30e9SPL set ID e16705d8-4472-4f83-96ac-69fa2be066cbRxCUI 1441392, 1441740UNII IU5QR144QX, J70472UD3D
- Pharmacologic class
- Estrogen Agonist/Antagonist; 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 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
N463539012207followed by a unit qualifier and the quantityPackage 63539-0122-07. 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)
DUAVEE is indicated in women with a uterus for: DUAVEE is a combination of conjugated estrogens with an estrogen agonist/antagonist indicated for treatment of the following conditions in women with a uterus: • Treatment of moderate to severe vasomotor symptoms associated with menopause ( 1.1 ) • Prevention of postmenopausal osteoporosis ( 1.2 ) Limitation of Use : DUAVEE should be used for the shortest duration consistent with treatment goals and risks for the individual woman ( 1.3 ) 1.1 Treatment of Moderate to Severe Vasomotor Symptoms Associated with Menopause 1.2 Prevention of Postmenopausal Osteoporosis 1.3 Important Limitations of Use • Use DUAVEE for the shortest duration consistent …
Excerpt only. Read the full label for complete information.
About NDC 63539-122
- What is NDC 63539-122?
- 63539-122 is the product NDC for Duavee (conjugated estrogens/bazedoxifene), Estrogens, Conjugated .45 mg/1; Bazedoxifene acetate 20 mg/1 tablet, film coated, listed with the FDA by U.S. Pharmaceuticals. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Duavee (Conjugated estrogens/bazedoxifene).
- What is the active ingredient?
- Estrogens, Conjugated, Bazedoxifene acetate.
- Who is the labeler?
- U.S. Pharmaceuticals, NDC labeler code 63539. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Duavee?
- 1 other product NDC are listed under this name. See all Duavee NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Duavee products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Duaveeconjugated estrogens/bazedoxifene | Estrogens, Conjugated .45 mg/1; Bazedoxifene acetate 20 mg/1 | Tablet, Film coatedOral | Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. | 0008-1123 | 00008-1123-12 |
Other NDCs under NDA 022247
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 |
|---|---|---|---|---|
| Duaveeconjugated estrogens/bazedoxifene | Estrogens, Conjugated .45 mg/1; Bazedoxifene acetate 20 mg/1 | Tablet, Film coatedOral | Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. | 0008-1123 |