Prescription drug · ANDA
Lyllana (Estradiol) NDC 65162-148
Estradiol .0375 mg/d · Patch, Extended release · Transdermal · Amneal Pharmaceuticals LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 65162-148-08 | 65162014808 | 8 POUCH in 1 CARTON (65162-148-08) / 1 d in 1 POUCH (65162-148-04)Marketed from Sep 30, 2020 |
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)
- Lyllana
- Generic name (nonproprietary)
- estradiol
- Active ingredients
- Estradiol — .0375 mg/d
- Dosage form
- Patch, Extended release
- Route
- Transdermal
- Labeler
- Amneal Pharmaceuticals LLCNDC labeler code 65162
- 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 65162-148_6828b547-27f6-4099-981f-a8efcba66370SPL ID 6828b547-27f6-4099-981f-a8efcba66370SPL set ID 09c472c6-a38a-4a3d-b048-6fefd52e2ad3RxCUI 241946, 242891, 242892, 248478, 1149632, 2399892, 2399895, 2399898, 2399901, 2399904UNII 4TI98Z838EUPC 0365162126082, 0365162150087, 0365162148084, 0365162228083, 0365162149081
- 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
N465162014808followed by a unit qualifier and the quantityPackage 65162-0148-08. 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)
LYLLANA is indicated for: LYLLANA ® 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-estrogen medications. Consider estrogen ther…
Excerpt only. Read the full label for complete information.
About NDC 65162-148
- What is NDC 65162-148?
- 65162-148 is the product NDC for Lyllana (estradiol), Estradiol .0375 mg/d patch, extended release, listed with the FDA by Amneal Pharmaceuticals LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Lyllana (Estradiol).
- What is the active ingredient?
- Estradiol.
- Who is the labeler?
- Amneal Pharmaceuticals LLC, NDC labeler code 65162. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Lyllana?
- 4 other product NDCs are listed under this name. See all Lyllana NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Lyllana products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Lyllanaestradiol | Estradiol .025 mg/d | Patch, Extended releaseTransdermal | Amneal Pharmaceuticals LLC | 65162-126 | 65162-0126-08 |
| Lyllanaestradiol | Estradiol .05 mg/d | Patch, Extended releaseTransdermal | Amneal Pharmaceuticals LLC | 65162-149 | 65162-0149-08 |
| Lyllanaestradiol | Estradiol .075 mg/d | Patch, Extended releaseTransdermal | Amneal Pharmaceuticals LLC | 65162-150 | 65162-0150-08 |
| Lyllanaestradiol | Estradiol .1 mg/d | Patch, Extended releaseTransdermal | Amneal Pharmaceuticals LLC | 65162-228 | 65162-0228-08 |
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 .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 |
| Estradiol | Estradiol .05 mg/d | Patch, Extended releaseTransdermal | Amneal Pharmaceuticals NY LLC | 69238-1295 |
| Estradiol | Estradiol .1 mg/d | Patch, Extended releaseTransdermal | Amneal Pharmaceuticals NY LLC | 69238-1296 |
| Estradiol | Estradiol .025 mg/d | Patch, Extended releaseTransdermal | Amneal Pharmaceuticals NY LLC | 69238-1447 |
| Lyllanaestradiol | Estradiol .025 mg/d | Patch, Extended releaseTransdermal | Amneal Pharmaceuticals LLC | 65162-126 |
| Lyllanaestradiol | Estradiol .05 mg/d | Patch, Extended releaseTransdermal | Amneal Pharmaceuticals LLC | 65162-149 |
| Lyllanaestradiol | Estradiol .075 mg/d | Patch, Extended releaseTransdermal | Amneal Pharmaceuticals LLC | 65162-150 |
| Lyllanaestradiol | Estradiol .1 mg/d | Patch, Extended releaseTransdermal | Amneal Pharmaceuticals LLC | 65162-228 |