Prescription drug · ANDA
Estradiol (Estradiol transdermal) NDC 69238-2451
Estradiol .5 mg/.5g · Gel · Topical · Amneal Pharmaceuticals NY LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69238-2451-3 | 69238245103 | 30 PACKET in 1 CARTON (69238-2451-3) / .5 g in 1 PACKET (69238-2451-1)Marketed from Jul 15, 2024 |
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 transdermal
- Active ingredients
- Estradiol — .5 mg/.5g
- Dosage form
- Gel
- Route
- Topical
- Labeler
- Amneal Pharmaceuticals NY LLCNDC labeler code 69238
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 216055
- Marketing start
- Listing expires
- Other FDA classes
- Estradiol Congeners (Chemical structure)Estrogen Receptor Agonists (Mechanism)
- Identifiers
- Product ID 69238-2451_cebb61d3-34b7-44a7-aae7-d23e21651713SPL ID cebb61d3-34b7-44a7-aae7-d23e21651713SPL set ID 9669a0e3-27e2-4f6c-961c-7a67e9f84cc8RxCUI 2619677, 2619679, 2619681, 2619683, 2619685UNII 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. Topical products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N469238245103followed by a unit qualifier and the quantityPackage 69238-2451-03. 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)
Estradiol gel, 0.1% is an estrogen indicated for the treatment of moderate to severe vasomotor symptoms due to menopause (1.1) . 1.1 Treatment of Moderate to Severe Vasomotor Symptoms due to Menopause
Excerpt only. Read the full label for complete information.
About NDC 69238-2451
- What is NDC 69238-2451?
- 69238-2451 is the product NDC for Estradiol (estradiol transdermal), Estradiol .5 mg/.5g gel, listed with the FDA by Amneal Pharmaceuticals NY LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Estradiol (Estradiol Transdermal).
- What is the active ingredient?
- Estradiol.
- Who is the labeler?
- Amneal Pharmaceuticals NY LLC, NDC labeler code 69238. 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?
- 184 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 216055
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 |
|---|---|---|---|---|
| Estradiolestradiol transdermal | Estradiol 1.25 mg/1.25g | GelTopical | Amneal Pharmaceuticals NY LLC | 69238-2448 |
| Estradiolestradiol transdermal | Estradiol 1 mg/g | GelTopical | Amneal Pharmaceuticals NY LLC | 69238-2449 |
| Estradiolestradiol transdermal | Estradiol .75 mg/.75g | GelTopical | Amneal Pharmaceuticals NY LLC | 69238-2450 |
| Estradiolestradiol transdermal | Estradiol .25 mg/.25g | GelTopical | Amneal Pharmaceuticals NY LLC | 69238-2452 |