Prescription drug · NDA
Premarin NDC 50090-1853
estrogens, conjugated · Estrogens, Conjugated .3 mg/1 · Tablet, Film coated · Oral · A-S Medication Solutions
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50090-1853-3 | 50090185303 | 30 TABLET, FILM COATED in 1 BOTTLE (50090-1853-3)Marketed from Jun 2, 2015 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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)
- Premarin
- Generic name (nonproprietary)
- estrogens, conjugated
- Active ingredients
- Estrogens, Conjugated — .3 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- A-S Medication Solutions
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 004782
- Marketing start
- Listing expires
- Other FDA classes
- Estrogen Receptor Agonists (Mechanism)Conjugated (USP) (Chemical structure)
- Identifiers
- Product ID 50090-1853_162fd047-bf5c-4c7d-9a60-01f0deb54290SPL ID 162fd047-bf5c-4c7d-9a60-01f0deb54290SPL set ID 2b4dbb7c-4e6d-47c9-b940-fef91f1f4a05RxCUI 197660, 208513UNII IU5QR144QX
- Pharmacologic class
- 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
N450090185303followed by a unit qualifier and the quantityPackage 50090-1853-03. 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)
PREMARIN is a mixture of estrogens indicated 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 ) • Treatment of Hypoestrogenism due to Hypogonadism, Castration or Primary Ovarian Failure ( 1.3 ) • Treatment of Breast Cancer (for Palliation Only) in Appropriately Selected Women and Men with Metastatic Disease ( 1.4 ) • Treatment of Advanced Androgen-Dependent Carcinoma of the Prostate (for Palliation Only) ( 1.5 ) • Prevention of Postmenopausal Osteoporosis ( 1.6 ) 1.1 Treatment of Moderate to Severe Vasomotor Symptoms due to Menopause 1.2 Treatment of Moderate to Severe Sympto…
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 004782
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 |
|---|---|---|---|---|
| Premarinestrogens, conjugated | Estrogens, Conjugated 1.25 mg/1 | Tablet, Film coatedOral | Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. | 0046-1104 |
| Premarinestrogens, conjugated | Estrogens, Conjugated .625 mg/1 | Tablet, Film coatedOral | Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. | 0046-1102 |
| Premarinestrogens, conjugated | Estrogens, Conjugated .3 mg/1 | Tablet, Film coatedOral | Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. | 0046-1100 |
| Premarinestrogens, conjugated | Estrogens, Conjugated .9 mg/1 | Tablet, Film coatedOral | Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. | 0046-1103 |
| Premarinestrogens, conjugated | Estrogens, Conjugated .45 mg/1 | Tablet, Film coatedOral | Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. | 0046-1101 |
| Conjugated Estrogensestrogens, conjugated | Estrogens, Conjugated .625 mg/1 | Tablet, Film coatedOral | Prasco Laboratories | 66993-297 |
| Conjugated Estrogensestrogens, conjugated | Estrogens, Conjugated .3 mg/1 | Tablet, Film coatedOral | Prasco Laboratories | 66993-295 |
| Conjugated Estrogensestrogens, conjugated | Estrogens, Conjugated .45 mg/1 | Tablet, Film coatedOral | Prasco Laboratories | 66993-296 |
| Conjugated Estrogensestrogens, conjugated | Estrogens, Conjugated .9 mg/1 | Tablet, Film coatedOral | Prasco Laboratories | 66993-298 |
| Conjugated Estrogensestrogens, conjugated | Estrogens, Conjugated 1.25 mg/1 | Tablet, Film coatedOral | Prasco Laboratories | 66993-299 |
| Premarinestrogens, conjugated | Estrogens, Conjugated .625 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-0167 |