Prescription drug · ANDA
Estradiol NDC 82804-319
Estradiol 2 mg/1 · Tablet · Oral · Proficient Rx LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 82804-319-30 | 8280403193082804031930 | 30 TABLET in 1 BOTTLE (82804-319-30)Marketed from Sep 25, 2026 |
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)
- Estradiol
- Generic name (nonproprietary)
- estradiol
- Active ingredients
- Estradiol — 2 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Proficient Rx LPNDC labeler code 82804
- 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 82804-319_8c6af012-3c85-4035-824b-adf356ddbb7dSPL ID 8c6af012-3c85-4035-824b-adf356ddbb7d
- 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
N482804031930followed by a unit qualifier and the quantityPackage 82804-0319-30. 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
The FDA listing for this product does not reference a label (SPL) set.
About NDC 82804-319
- What is NDC 82804-319?
- 82804-319 is the product NDC for Estradiol, Estradiol 2 mg/1 tablet, listed with the FDA by Proficient Rx LP. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Estradiol.
- What is the active ingredient?
- Estradiol.
- Who is the labeler?
- Proficient Rx LP, NDC labeler code 82804. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Estradiol?
- 182 other product NDCs are listed under this name. See all Estradiol NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Estradiol products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Estradiol | Estradiol .75 mg/1.25g | GelTransdermal | Encube Ethicals, Inc. | 21922-015 | 21922-0015-40 |
| Estradiol | Estradiol .75 mg/1.25g | GelTopical | Solaris Pharma Corporation | 73473-308 | 73473-0308-50 |
| Estradiol | Estradiol .5 mg/1 | TabletOral | Direct_Rx | 72189-655 | 72189-0655-60 |
| Estradiol | Estradiol .5 mg/1 | TabletOral | Coupler LLC | 67046-1568 | 67046-1568-03 |
| Estradiol | Estradiol 1 mg/1 | TabletOral | American Health Packaging | 60687-876 | 60687-0876-65 |
| Estradiol | Estradiol 1 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-8860 | 68788-8860-0168788-8860-0368788-8860-06+1 more |
| Estradiol | Estradiol .75 mg/1.25g | Gel, MeteredTopical | ANI Pharmaceuticals, Inc. | 70954-646 | 70954-0646-10 |
| Estradiolestradiol transdermal | Estradiol 1.25 mg/1.25g | GelTopical | Amneal Pharmaceuticals NY LLC | 69238-2448 | 69238-2448-03 |
| Estradiolestradiol transdermal | Estradiol 1 mg/g | GelTopical | Amneal Pharmaceuticals NY LLC | 69238-2449 | 69238-2449-03 |
| Estradiolestradiol transdermal | Estradiol .75 mg/.75g | GelTopical | Amneal Pharmaceuticals NY LLC | 69238-2450 | 69238-2450-03 |
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 | A-S Medication Solutions | 50090-7480 |
| Estradiol | Estradiol 1 mg/1 | TabletOral | A-S Medication Solutions | 50090-7481 |
| Estradiol | Estradiol .5 mg/1 | TabletOral | Coupler LLC | 67046-1568 |
| Estradiol | Estradiol 1 mg/1 | TabletOral | Redpharm Drug | 67296-2279 |
| Estradiol | Estradiol 1 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-3629 |
| Estradiol | Estradiol 2 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-3689 |
| Estradiol | Estradiol .5 mg/1 | TabletOral | Preferred Pharmaceuticals, Inc. | 68788-8626 |
| Estradiol | Estradiol 1 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-8860 |
| Estradiol | Estradiol 2 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-3910 |
| Estradiol | Estradiol 1 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-3922 |
| Estradiol | Estradiol .5 mg/1 | TabletOral | ANI Pharmaceuticals, Inc. | 70954-564 |
| Estradiol | Estradiol 1 mg/1 | TabletOral | ANI Pharmaceuticals, Inc. | 70954-565 |
| Estradiol | Estradiol 2 mg/1 | TabletOral | ANI Pharmaceuticals, Inc. | 70954-566 |
| Estradiol | Estradiol 1 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2387 |
| Estradiol | Estradiol 2 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2477 |
| Estradiol | Estradiol .5 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2892 |
| Estradiol | Estradiol .5 mg/1 | TabletOral | Direct_Rx | 72189-655 |
| Estradiol | Estradiol .5 mg/1 | TabletOral | NorthStar Rx LLC | 72603-273 |
| Estradiol | Estradiol 1 mg/1 | TabletOral | NorthStar Rx LLC | 72603-274 |
| Estradiol | Estradiol 2 mg/1 | TabletOral | NorthStar Rx LLC | 72603-275 |
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