Prescription drug · NDA
Prempro NDC 0046-1106
conjugated estrogens and medroxyprogesterone acetate · Estrogens, Conjugated .45 mg/1; Medroxyprogesterone acetate 1.5 mg/1 · Tablet, Sugar coated · Oral · Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0046-1106-11 | 00046110611 | 1 BLISTER PACK in 1 CARTON (0046-1106-11) / 28 TABLET, SUGAR COATED in 1 BLISTER PACKMarketed from Sep 21, 2009 |
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)
- Prempro
- Generic name (nonproprietary)
- conjugated estrogens and medroxyprogesterone acetate
- Active ingredients
- Estrogens, Conjugated — .45 mg/1Medroxyprogesterone acetate — 1.5 mg/1
- Dosage form
- Tablet, Sugar coated
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 020527
- Marketing start
- Listing expires
- Other FDA classes
- Estrogen Receptor Agonists (Mechanism)Conjugated (USP) (Chemical structure)Progesterone Congeners (Chemical structure)
- Identifiers
- Product ID 0046-1106_cce04608-5f9f-434f-b4ab-d5c19847095aSPL ID cce04608-5f9f-434f-b4ab-d5c19847095aSPL set ID fd0c0836-5d23-2183-da81-9dc7f4287052RxCUI 150840, 310197, 1000351, 1000352, 1000355, 1000356, 1000395, 1000398, 1000486, 1000487, 1000490, 1000491, 1000496, 1000497, 1000499, 1000500UNII C2QI4IOI2G, IU5QR144QX
- Pharmacologic class
- Estrogen; Progestin
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
N400046110611followed by a unit qualifier and the quantityPackage 00046-1106-11. 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)
PREMPRO/PREMPHASE is an estrogen plus progestin indicated in a woman with a uterus for: • Treatment of Moderate to Severe Vasomotor Symptoms due to Menopause ( 1.1 ) • Treatment of Moderate to Severe Vulvar and Vaginal Atrophy due to Menopause ( 1.2 ) • Prevention of Postmenopausal Osteoporosis ( 1.3 ) 1.1 Treatment of Moderate to Severe Vasomotor Symptoms due to Menopause 1.2 Treatment of Moderate to Severe Vulvar and Vaginal Atrophy due to Menopause 1.3 Prevention of Postmenopausal Osteoporosis
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 020527
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 |
|---|---|---|---|---|
| Premproconjugated estrogens and medroxyprogesterone acetate | Estrogens, Conjugated .625 mg/1; Medroxyprogesterone acetate 5 mg/1 | Tablet, Sugar coatedOral | Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. | 0046-1108 |
| Premphaseconjugated estrogens and medroxyprogesterone acetate | — | Kit | Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. | 0046-2575 |
| Premproconjugated estrogens and medroxyprogesterone acetate | Estrogens, Conjugated .625 mg/1; Medroxyprogesterone acetate 2.5 mg/1 | Tablet, Sugar coatedOral | Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. | 0046-1107 |
| Premproconjugated estrogens and medroxyprogesterone acetate | Estrogens, Conjugated .3 mg/1; Medroxyprogesterone acetate 1.5 mg/1 | Tablet, Sugar coatedOral | Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. | 0046-1105 |