Prescription drug · ANDA
Levonest (Levonorgestrel and ethinyl estradiol) NDC 16714-340
Kit · Northstar Rx LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 16714-340-01 | 1671403400116714034001 | 1 BLISTER PACK in 1 PACKET (16714-340-01) / 1 KIT in 1 BLISTER PACKMarketed from Dec 29, 2010 | |
| 16714-340-02 | 1671403400216714034002 | 1 BLISTER PACK in 1 CARTON (16714-340-02) / 1 KIT in 1 BLISTER PACKMarketed from Dec 29, 2010 | |
| 16714-340-03 | 1671403400316714034003 | 3 BLISTER PACK in 1 CARTON (16714-340-03) / 1 KIT in 1 BLISTER PACKMarketed from Dec 29, 2010 | |
| 16714-340-04 | 1671403400416714034004 | 6 BLISTER PACK in 1 CARTON (16714-340-04) / 1 KIT in 1 BLISTER PACKMarketed from Dec 29, 2010 |
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)
- Levonest
- Generic name (nonproprietary)
- levonorgestrel and ethinyl estradiol
- Dosage form
- Kit
- Labeler
- Northstar Rx LLCNDC labeler code 16714
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 090719
- Marketing start
- Listing expires
- Identifiers
- Product ID 16714-340_8057bfb7-5eeb-404f-9614-4e629c2d1f4bSPL ID 8057bfb7-5eeb-404f-9614-4e629c2d1f4bSPL set ID be7000f1-5bf1-4de5-a256-e4436c37f0a1RxCUI 310230, 348804, 348805, 748797, 748832, 1095227
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
N416714034001followed by a unit qualifier and the quantityPackage 16714-0340-01. 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 Oral contraceptives are indicated for the prevention of pregnancy in women who elect to use this product as a method of contraception. Oral contraceptives are highly effective. Table I lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization and the IUD, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates. TABLE I: PERCENTAGE OF WOMEN EXPERIENCING AN UNINTENDED PREGNANCY DURING THE FIRST YEAR OF USE OF A CONTRACEPTIVE METHOD Method Perfect Use Typical Use Levonorg…
Excerpt only. Read the full label for complete information.
About NDC 16714-340
- What is NDC 16714-340?
- 16714-340 is the product NDC for Levonest kit, listed with the FDA by Northstar Rx LLC. It has 4 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Levonest (Levonorgestrel and ethinyl estradiol).
- Who is the labeler?
- Northstar Rx LLC, NDC labeler code 16714. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Levonest?
- 1 other product NDC are listed under this name. See all Levonest NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Levonest products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Levonestlevonorgestrel and ethinyl estradiol | — | Kit | A-S Medication Solutions | 50090-2505 | 50090-2505-00 |
Other NDCs under ANDA 090719
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 |
|---|---|---|---|---|
| Levonestlevonorgestrel and ethinyl estradiol | — | Kit | A-S Medication Solutions | 50090-2505 |