Prescription drug · ANDA
Estradiol NDC 67046-1568
Estradiol .5 mg/1 · Tablet · Oral · Coupler LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 67046-1568-3 | 67046156803 | 30 TABLET in 1 BLISTER PACK (67046-1568-3)Marketed from Jun 17, 2025 |
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)
- Estradiol
- Generic name (nonproprietary)
- estradiol
- Active ingredients
- Estradiol — .5 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Coupler LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 217334
- Marketing start
- Listing expires
- Other FDA classes
- Estradiol Congeners (Chemical structure)Estrogen Receptor Agonists (Mechanism)
- Identifiers
- Product ID 67046-1568_37c99db2-4680-0f78-e063-6394a90a8483SPL ID 37c99db2-4680-0f78-e063-6394a90a8483SPL set ID 37c99e4d-fb0d-0e6e-e063-6394a90a69c8RxCUI 197657UNII 4TI98Z838E
- 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
N467046156803followed by a unit qualifier and the quantityPackage 67046-1568-03. 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)
INDICATIONS & USAGE Estradiol tablets are indicated in the: Treatment of moderate to severe vasomotor symptoms associated with the menopause. Treatment of moderate to severe symptoms of vulvar and vaginal atrophy associated with the menopause. When prescribing solely for the treatment of symptoms of vulvar and vaginal atrophy, topical vaginal products should be considered. Treatment of hypoestrogenism due to hypogonadism, castration or primary ovarian failure. Treatment of breast cancer (for palliation only) in appropriately selected women and men with metastatic disease. Treatment of advanced androgen-dependent carcinoma of the prostate (for palliation only). Prevention of osteoporosis. Whe…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 217334
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 |
|---|---|---|---|---|
| Estradiol | Estradiol 1 mg/1 | TabletOral | ANI Pharmaceuticals, Inc. | 70954-565 |
| Estradiol | Estradiol .5 mg/1 | TabletOral | ANI Pharmaceuticals, Inc. | 70954-564 |
| Estradiol | Estradiol 2 mg/1 | TabletOral | ANI Pharmaceuticals, Inc. | 70954-566 |
| Estradiol | Estradiol .5 mg/1 | TabletOral | NorthStar Rx LLC | 72603-273 |
| Estradiol | Estradiol .5 mg/1 | TabletOral | Direct_Rx | 72189-655 |
| Estradiol | Estradiol 1 mg/1 | TabletOral | NorthStar Rx LLC | 72603-274 |
| Estradiol | Estradiol 2 mg/1 | TabletOral | NorthStar Rx LLC | 72603-275 |
| Estradiol | Estradiol .5 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2892 |
| Estradiol | Estradiol 1 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-3629 |
| Estradiol | Estradiol 1 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2387 |
| Estradiol | Estradiol 2 mg/1 | TabletOral | Northwind Health Company, LLC | 82868-026 |
| Estradiol | Estradiol 2 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-3910 |
| Estradiol | Estradiol 1 mg/1 | TabletOral | Northwind Health Company, LLC | 82868-038 |
| Estradiol | Estradiol 1 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-8860 |
| Estradiol | Estradiol 1 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-3922 |
| Estradiol | Estradiol 2 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-3689 |
| Estradiol | Estradiol .5 mg/1 | TabletOral | Preferred Pharmaceuticals, Inc. | 68788-8626 |
| Estradiol | Estradiol 2 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2477 |
| Estradiol | Estradiol 1 mg/1 | TabletOral | A-S Medication Solutions | 50090-7480 |
| Estradiol | Estradiol 1 mg/1 | TabletOral | A-S Medication Solutions | 50090-7481 |
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