Prescription drug · ANDA
Vienva NDC 70700-118
levonorgestrel and ethinyl estradiol · Kit · Xiromed, LLC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70700-118-85 | 70700011885 | 3 BLISTER PACK in 1 CARTON (70700-118-85) / 1 KIT in 1 BLISTER PACKMarketed from Feb 10, 2023 |
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)
- Vienva
- Generic name (nonproprietary)
- levonorgestrel and ethinyl estradiol
- Dosage form
- Kit
- Labeler
- Xiromed, LLC.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 201088
- Marketing start
- Listing expires
- Identifiers
- Product ID 70700-118_29dd6d20-0953-5b7d-e9e0-1d5ff14a9298SPL ID 29dd6d20-0953-5b7d-e9e0-1d5ff14a9298SPL set ID 58ea31df-f9cf-7d00-c2db-0529fb9a3e53RxCUI 242297, 748797, 748868, 1720616UPC 0370700118856
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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- NDC on a medical claim
N470700011885followed by a unit qualifier and the quantityPackage 70700-0118-85. 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 .
Indications (excerpt from the label)
INDICATIONS AND USAGE Vienva (levonorgestrel and ethinyl estradiol tablets, USP) is indicated for use by females of reproductive potential to prevent pregnancy. Limitations of use : The efficacy of levonorgestrel and ethinyl estradiol in women with a body mass index (BMI) of > 35 kg/m 2 has not been adequately evaluated. In a clinical trial with levonorgestrel and ethinyl estradiol tablets, 1,477 subjects had 7,720 cycles of use and a total of 5 pregnancies were reported. This represents an overall pregnancy rate of 0.84 per 100 woman-years. This rate includes patients who did not take the drug correctly. One or more pills were missed during 1,479 (18.8%) of the 7,870 cycles; thus all tablet…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 201088
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.