Prescription drug · ANDA
Kurvelo (Levonorgestrel and ethinyl estradiol) NDC 68180-844
Kit · Lupin Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68180-844-73 | 6818008447368180084473 | 3 BLISTER PACK in 1 CARTON (68180-844-73) / 1 KIT in 1 BLISTER PACK * 21 TABLET in 1 BLISTER PACK (68180-841-74) * 7 TABLET in 1 BLISTER PACK (68180-842-74)Marketed from Feb 7, 2021 |
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)
- Kurvelo
- Generic name (nonproprietary)
- levonorgestrel and ethinyl estradiol
- Dosage form
- Kit
- Labeler
- Lupin Pharmaceuticals, Inc.NDC labeler code 68180
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 091408
- Marketing start
- Listing expires
- Identifiers
- Product ID 68180-844_8f9181bf-d2bd-422c-a115-0adfaacd0c9fSPL ID 8f9181bf-d2bd-422c-a115-0adfaacd0c9fSPL set ID 752f525e-1838-4058-9ab7-2c2d91f86dfdRxCUI 238019, 748797, 748878, 1356074UPC 0368180844716
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
N468180084473followed by a unit qualifier and the quantityPackage 68180-0844-73. 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)
INDICATIONS AND USAGE Kurvelo is indicated for use by females of reproductive potential to prevent pregnancy.
Excerpt only. Read the full label for complete information.
About NDC 68180-844
- What is NDC 68180-844?
- 68180-844 is the product NDC for Kurvelo kit, listed with the FDA by Lupin Pharmaceuticals, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Kurvelo (Levonorgestrel and ethinyl estradiol).
- Who is the labeler?
- Lupin Pharmaceuticals, Inc., NDC labeler code 68180. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Kurvelo?
- 1 other product NDC are listed under this name. See all Kurvelo NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Kurvelo products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Kurvelolevonorgestrel and ethinyl estradiol | — | Kit | A-S Medication Solutions | 50090-6374 | 50090-6374-00 |
Other NDCs under ANDA 091408
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 |
|---|---|---|---|---|
| Kurvelolevonorgestrel and ethinyl estradiol | — | Kit | A-S Medication Solutions | 50090-6374 |