Prescription drug · NDA
Vivelle-Dot (estradiol) NDC 66758-149
Estradiol .1 mg/d · Patch, Extended release · Transdermal · Sandoz Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 66758-149-83 | 66758014983 | 8 POUCH in 1 BOX (66758-149-83) / 1 PATCH in 1 POUCH (66758-149-58) / 3.5 d in 1 PATCHMarketed from Jun 10, 2024 |
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)
- Vivelle-Dot
- Generic name (nonproprietary)
- estradiol
- Active ingredients
- Estradiol — .1 mg/d
- Dosage form
- Patch, Extended release
- Route
- Transdermal
- Labeler
- Sandoz Inc
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 020538
- Marketing start
- Listing expires
- Other FDA classes
- Estradiol Congeners (Chemical structure)Estrogen Receptor Agonists (Mechanism)
- Identifiers
- Product ID 66758-149_8e8ae172-5a0d-4888-a825-0c6cfa1afac9SPL ID 8e8ae172-5a0d-4888-a825-0c6cfa1afac9SPL set ID 5ccb77f9-d47b-4381-ad5c-5b92524e1c4aRxCUI 241946, 242891, 242892, 248478, 284378, 310172, 310176, 310183, 1149632, 1149634UNII 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
N466758014983followed by a unit qualifier and the quantityPackage 66758-0149-83. 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)
Vivelle-Dot is indicated for: Vivelle-Dot is an estrogen indicated for: • Treatment of moderate to severe vasomotor symptoms due to menopause ( 1.1 ) • Treatment of moderate to severe symptoms of vulvar and vaginal atrophy due to menopause ( 1.2 ) Limitations of Use When prescribing solely for the treatment of moderate to severe vaginal atrophy, first consider the use of topical vaginal products. • Treatment of hypoestrogenism due to hypogonadism, castration, or primary ovarian failure ( 1.3 ) • Prevention of postmenopausal osteoporosis ( 1.4 ) Limitations of Use When prescribing solely for the prevention of postmenopausal osteoporosis, first consider the use of non-estrogen medications. Con…
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 020538
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 .025 mg/d | Patch, Extended releaseTransdermal | Sandoz Inc | 0781-7129 |
| Vivelle-Dotestradiol | Estradiol .075 mg/d | Patch, Extended releaseTransdermal | Sandoz Inc | 66758-148 |
| Vivelle-Dotestradiol | Estradiol .025 mg/d | Patch, Extended releaseTransdermal | Sandoz Inc | 66758-145 |
| Vivelle-Dotestradiol | Estradiol .0375 mg/d | Patch, Extended releaseTransdermal | Sandoz Inc | 66758-146 |
| Vivelle-Dotestradiol | Estradiol .05 mg/d | Patch, Extended releaseTransdermal | Sandoz Inc | 66758-147 |
| Estradiol | Estradiol .0375 mg/d | Patch, Extended releaseTransdermal | Sandoz Inc | 0781-7138 |
| Estradiol | Estradiol .05 mg/d | Patch, Extended releaseTransdermal | Sandoz Inc | 0781-7144 |
| Estradiol | Estradiol .075 mg/d | Patch, Extended releaseTransdermal | Sandoz Inc | 0781-7156 |
| Estradiol | Estradiol .1 mg/d | Patch, Extended releaseTransdermal | Sandoz Inc | 0781-7167 |