Prescription drug · ANDA
Estradiol NDC 70518-3818
Estradiol 1 mg/1 · Tablet · Oral · REMEDYREPACK INC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70518-3818-0 | 70518381800 | 90 TABLET in 1 BOTTLE, PLASTIC (70518-3818-0)Marketed from Aug 3, 2023 | |
| 70518-3818-1 | 70518381801 | 100 POUCH in 1 BOX (70518-3818-1) / 1 TABLET in 1 POUCH (70518-3818-2)Marketed from May 26, 2026 |
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 — 1 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- REMEDYREPACK INC.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 040275
- Marketing start
- Listing expires
- Other FDA classes
- Estradiol Congeners (Chemical structure)Estrogen Receptor Agonists (Mechanism)
- Identifiers
- Product ID 70518-3818_53c1f4fc-2044-c013-e063-6394a90a744eSPL ID 53c1f4fc-2044-c013-e063-6394a90a744eSPL set ID 477cb52e-8ce2-491f-94a0-869ff60bf7abRxCUI 197658UNII 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
N470518381800followed by a unit qualifier and the quantityPackage 70518-3818-00. 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 AND 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. W…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 040275
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 2 mg/1 | TabletOral | A-S Medication Solutions | 50090-6363 |
| Estradiol | Estradiol 1 mg/1 | TabletOral | A-S Medication Solutions | 50090-6359 |
| Estradiol | Estradiol 2 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-4485 |
| Estradiol | Estradiol 1 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-7102 |
| Estradiol | Estradiol 2 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-4788 |
| Estradiol | Estradiol .5 mg/1 | TabletOral | A-S Medication Solutions | 50090-5494 |
| Estradiol | Estradiol 1 mg/1 | TabletOral | A-S Medication Solutions | 50090-7452 |
| Estradiol | Estradiol 1 mg/1 | TabletOral | Direct_Rx | 72189-502 |
| Estradiol | Estradiol 1 mg/1 | TabletOral | NuCare Pharmaceuticals, Inc. | 68071-3394 |
| Estradiol | Estradiol 1 mg/1 | TabletOral | Asclemed USA, Inc. | 76420-022 |
| Estradiol | Estradiol .5 mg/1 | TabletOral | Asclemed USA, Inc. | 76420-021 |
| Estradiol | Estradiol 2 mg/1 | TabletOral | Direct_Rx | 72189-508 |
| Estradiol | Estradiol .5 mg/1 | TabletOral | Asclemed USA, Inc. | 76420-021 |
| Estradiol | Estradiol 2 mg/1 | TabletOral | Asclemed USA, Inc. | 76420-023 |
| Estradiol | Estradiol 1 mg/1 | TabletOral | Asclemed USA, Inc. | 76420-022 |
| Estradiol | Estradiol 2 mg/1 | TabletOral | Asclemed USA, Inc. | 76420-023 |
| Estradiol | Estradiol .5 mg/1 | TabletOral | PURACAP LABORATORIES, LLC | 24658-702 |
| Estradiol | Estradiol 1 mg/1 | TabletOral | PURACAP LABORATORIES, LLC | 24658-703 |
| Estradiol | Estradiol 2 mg/1 | TabletOral | PURACAP LABORATORIES, LLC | 24658-704 |
| Estradiol | Estradiol 1 mg/1 | TabletOral | EPIC PHARMA, LLC | 42806-088 |
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