Prescription drug · NDA
Duavee (conjugated estrogens/bazedoxifene) NDC 0008-1123
Estrogens, Conjugated .45 mg/1; Bazedoxifene acetate 20 mg/1 · Tablet, Film coated · Oral · Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0008-1123-12 | 00008112312 | 1 POUCH in 1 CARTON (0008-1123-12) / 2 BLISTER PACK in 1 POUCH / 15 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Oct 3, 2013 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 022247
- Marketing start
- Listing expires
- Other FDA classes
- Estrogen Receptor Agonists (Mechanism)Conjugated (USP) (Chemical structure)Selective Estrogen Receptor Modulators (Mechanism)
- Identifiers
- Product ID 0008-1123_3b6b80ea-b8f1-4a40-bd09-0fc3ff88b498SPL ID 3b6b80ea-b8f1-4a40-bd09-0fc3ff88b498SPL set ID e1b75458-2e5b-46b9-92c6-fa6daba3770fRxCUI 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
N400008112312followed by a unit qualifier and the quantityPackage 00008-1123-12. 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.
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 | U.S. Pharmaceuticals | 63539-122 |