Prescription drug · ANDA
Estradiol NDC 69238-1447
Estradiol .025 mg/d · Patch, Extended release · Transdermal · Amneal Pharmaceuticals NY LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69238-1447-7 | 69238144707 | 8 POUCH in 1 CARTON (69238-1447-7) / 1 d in 1 POUCH (69238-1447-1)Marketed from Sep 30, 2020 |
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 — .025 mg/d
- Dosage form
- Patch, Extended release
- Route
- Transdermal
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 211396
- Marketing start
- Listing expires
- Other FDA classes
- Estradiol Congeners (Chemical structure)Estrogen Receptor Agonists (Mechanism)
- Identifiers
- Product ID 69238-1447_257bffaf-8bc9-4557-a1e3-bab40bee2fb7SPL ID 257bffaf-8bc9-4557-a1e3-bab40bee2fb7SPL set ID d4259bb8-91f8-4587-8ceb-35d44145aec0RxCUI 241946, 242891, 242892, 248478, 1149632UNII 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. Transdermal products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N469238144707followed by a unit qualifier and the quantityPackage 69238-1447-07. 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 transdermal system is indicated for: Estradiol transdermal system is an estrogen indicated for: Treatment of moderate to severe vasomotor symptoms due to menopause ( 1.1 ) Prevention of postmenopausal osteoporosis ( 1.2 ) Limitations of Use When prescribing solely for the treatment of postmenopausal osteoporosis, first consider the use of non-estrogen medications. Consider estrogen therapy only for women at significant risk of osteoporosis. 1.1 Treatment of Moderate to Severe Vasomotor Symptoms Due to Menopause 1.2 Prevention of Postmenopausal Osteoporosis Limitation of Use When prescribing solely for the prevention of postmenopausal osteoporosis, first consider the use of non-estr…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 211396
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/d | Patch, Extended releaseTransdermal | Amneal Pharmaceuticals NY LLC | 69238-1296 |
| Estradiol | Estradiol .05 mg/d | Patch, Extended releaseTransdermal | Amneal Pharmaceuticals NY LLC | 69238-1295 |
| Estradiol | Estradiol .0375 mg/d | Patch, Extended releaseTransdermal | Amneal Pharmaceuticals NY LLC | 69238-1293 |
| Estradiol | Estradiol .075 mg/d | Patch, Extended releaseTransdermal | Amneal Pharmaceuticals NY LLC | 69238-1294 |
| Lyllanaestradiol | Estradiol .025 mg/d | Patch, Extended releaseTransdermal | Amneal Pharmaceuticals LLC | 65162-126 |
| Lyllanaestradiol | Estradiol .075 mg/d | Patch, Extended releaseTransdermal | Amneal Pharmaceuticals LLC | 65162-150 |
| Lyllanaestradiol | Estradiol .0375 mg/d | Patch, Extended releaseTransdermal | Amneal Pharmaceuticals LLC | 65162-148 |
| Lyllanaestradiol | Estradiol .05 mg/d | Patch, Extended releaseTransdermal | Amneal Pharmaceuticals LLC | 65162-149 |
| Lyllanaestradiol | Estradiol .1 mg/d | Patch, Extended releaseTransdermal | Amneal Pharmaceuticals LLC | 65162-228 |