Prescription drug · ANDA
estrogens, conjugated NDC 50742-387
Estrogens, Conjugated .3 mg/1 · Tablet, Film coated · Oral · Ingenus Pharmaceuticals, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50742-387-01 | 50742038701 | 100 TABLET, FILM COATED in 1 BOTTLE (50742-387-01)Marketed from Oct 16, 2025 | |
| 50742-387-10 | 50742038710 | 1000 TABLET, FILM COATED in 1 BOTTLE (50742-387-10)Marketed from Oct 16, 2025 |
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)
- estrogens, conjugated
- Generic name (nonproprietary)
- estrogens, conjugated
- Active ingredients
- Estrogens, Conjugated — .3 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Ingenus Pharmaceuticals, LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 214025
- Marketing start
- Listing expires
- Other FDA classes
- Estrogen Receptor Agonists (Mechanism)Conjugated (USP) (Chemical structure)
- Identifiers
- Product ID 50742-387_30ffc7b1-ebec-40a2-a4a9-2f1f5bdba535SPL ID 30ffc7b1-ebec-40a2-a4a9-2f1f5bdba535SPL set ID b17eca23-f387-4243-a76a-bcf6b88aeef9RxCUI 197660, 310197, 403849UNII IU5QR144QXUPC 0350742387014, 0350742389018, 0350742388011
- 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
N450742038701followed by a unit qualifier and the quantityPackage 50742-0387-01. 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)
Conjugated estrogens tablets 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 t…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 214025
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 |
|---|---|---|---|---|
| estrogens, conjugated | Estrogens, Conjugated .45 mg/1 | Tablet, Film coatedOral | Ingenus Pharmaceuticals, LLC | 50742-388 |
| estrogens, conjugated | Estrogens, Conjugated .625 mg/1 | Tablet, Film coatedOral | Ingenus Pharmaceuticals, LLC | 50742-389 |