Prescription drug · ANDA
Lutera (Levonorgestrel and ethinyl estradiol) NDC 55741-005
Kit · Dr. Reddys Laboratories Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 55741-005-06 | 5574100050655741000506 | 6 BLISTER PACK in 1 CARTON (55741-005-06) / 1 KIT in 1 BLISTER PACKMarketed from Feb 13, 2026 | |
| 55741-005-28 | 5574100052855741000528 | 1 BLISTER PACK in 1 PACKET (55741-005-28) / 1 KIT in 1 BLISTER PACKMarketed from Feb 13, 2026 |
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)
- Lutera
- Generic name (nonproprietary)
- levonorgestrel and ethinyl estradiol
- Dosage form
- Kit
- Labeler
- Dr. Reddys Laboratories Inc.NDC labeler code 55741
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 090721
- Marketing start
- Listing expires
- Identifiers
- Product ID 55741-005_eb48cc50-744a-4e77-b520-18a9522530aeSPL ID eb48cc50-744a-4e77-b520-18a9522530aeSPL set ID 47fc432b-2259-47d2-bba9-5e3aae583990RxCUI 242297, 748797, 748868, 751884
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
N455741000506followed by a unit qualifier and the quantityPackage 55741-0005-06. 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 Lutera is indicated for use by females of reproductive potential to prevent pregnancy. Limitations of use: The efficacy of Lutera 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 tablets were taken during 6,391 (81.2%) of the 7,870 cycles. Of the total 7,870 cycles, a…
Excerpt only. Read the full label for complete information.
About NDC 55741-005
- What is NDC 55741-005?
- 55741-005 is the product NDC for Lutera kit, listed with the FDA by Dr. Reddys Laboratories Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Lutera (Levonorgestrel and ethinyl estradiol).
- Who is the labeler?
- Dr. Reddys Laboratories Inc., NDC labeler code 55741. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Lutera?
- 1 other product NDC are listed under this name. See all Lutera NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Lutera products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Luteralevonorgestrel and ethinyl estradiol | — | Kit | Mayne Pharma Inc. | 51862-028 | — |
Other NDCs under ANDA 090721
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 |
|---|---|---|---|---|
| Falminalevonorgestrel and ethinyl estradiol | — | Kit | Northstar Rx LLC | 16714-359 |