Prescription drug · ANDA
Luizza 1.5/30 NDC 70700-314
norethindrone acetate and ethinyl estradiol · Ethinyl estradiol 30 ug/1; Norethindrone acetate 1.5 mg/1 · Tablet · Oral · Xiromed LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70700-314-79 | 7070003147970700031479 | 3 POUCH in 1 CARTON (70700-314-79) / 1 BLISTER PACK in 1 POUCH (70700-314-78) / 21 TABLET in 1 BLISTER PACKMarketed from Jan 29, 2025 |
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)
- Luizza 1.5/30
- Generic name (nonproprietary)
- norethindrone acetate and ethinyl estradiol
- Active ingredients
- Ethinyl estradiol — 30 ug/1Norethindrone acetate — 1.5 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Xiromed LLCNDC labeler code 70700
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 202770
- Marketing start
- Listing expires
- Other FDA classes
- Estrogen Receptor Agonists (Mechanism)Progesterone Congeners (Chemical structure)
- Identifiers
- Product ID 70700-314_689d38d7-80e3-b31c-396d-313bccdf7b33SPL ID 689d38d7-80e3-b31c-396d-313bccdf7b33SPL set ID b1c3e33d-ec95-cd89-7ad9-36994c802a1fRxCUI 1359022, 1359028, 2712092UNII 423D2T571U, 9S44LIC7OJ
- Pharmacologic class
- Estrogen; Progestin
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. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N470700031479followed by a unit qualifier and the quantityPackage 70700-0314-79. 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 Luizza 1.5/30 is indicated for the prevention of pregnancy in women who elect to use oral contraceptives 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, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates. TABLE I LOWEST EXPECTED AND TYPICAL FAILURE RATES DURING THE FIRST YEAR OF CONTINUOUS USE OF A METHOD Adapted from RA Hatcher et al, Reference 7. % Of Women Experiencing an…
Excerpt only. Read the full label for complete information.
About NDC 70700-314
- What is NDC 70700-314?
- 70700-314 is the product NDC for Luizza 1.5/30, Ethinyl estradiol 30 ug/1; Norethindrone acetate 1.5 mg/1 tablet, listed with the FDA by Xiromed LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Luizza 1.5/30 (Norethindrone acetate and ethinyl estradiol).
- What is the active ingredient?
- Ethinyl estradiol, Norethindrone acetate.
- Who is the labeler?
- Xiromed LLC, NDC labeler code 70700. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Luizza 1.5/30?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Other NDCs under ANDA 202770
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 |
|---|---|---|---|---|
| Norethindrone Acetate And Ethinyl Estradiol | Ethinyl estradiol .03 mg/1; Norethindrone acetate 1.5 mg/1 | TabletOral | Mylan Pharmaceuticals Inc. | 0378-7274 |