Prescription drug · ANDA
Levonorgestrel and Ethinyl Estradiol NDC 68462-637
Levonorgestrel 90 ug/1; Ethinyl estradiol 20 ug/1 · Tablet · Oral · Glenmark Pharmaceuticals Inc., USA
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68462-637-29 | 68462063729 | 3 POUCH in 1 CARTON (68462-637-29) / 1 BLISTER PACK in 1 POUCH (68462-637-84) / 28 TABLET in 1 BLISTER PACKMarketed from Apr 9, 2015 |
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)
- Levonorgestrel and Ethinyl Estradiol
- Generic name (nonproprietary)
- levonorgestrel and ethinyl estradiol
- Active ingredients
- Levonorgestrel — 90 ug/1Ethinyl estradiol — 20 ug/1
- Dosage form
- Tablet
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 202791
- Marketing start
- Listing expires
- Other FDA classes
- Estrogen Receptor Agonists (Mechanism)Inhibit Ovum Fertilization (Physiologic effect)Progesterone Congeners (Chemical structure)Progesterone Congeners (Chemical structure)
- Identifiers
- Product ID 68462-637_ed921f2c-7961-477a-bbac-2e666d32e3baSPL ID ed921f2c-7961-477a-bbac-2e666d32e3baSPL set ID 44fbc5ae-5682-471f-a12a-955e8b4d233aRxCUI 722152, 751553UNII 5W7SIA7YZW, 423D2T571UUPC 0368462637296, 0368462637845
- Pharmacologic class
- Estrogen; Progestin; Progestin-containing Intrauterine System
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
N468462063729followed by a unit qualifier and the quantityPackage 68462-0637-29. 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 Levonorgestrel and ethinyl estradiol tablets are indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. Oral contraceptives are highly effective for pregnancy prevention. Table 2 lists the typical unintended pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, the IUD, and implants, depend upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates. Table 2: Percentage of Women Experiencing an Unintended Pregnancy During The First Year of Ty…
Excerpt only. Read the full label for complete information.