Prescription drug · ANDA
Enskyce (Desogestrel and ethinyl estradiol) NDC 68180-739
Kit · Lupin Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68180-739-73 | 6818007397368180073973 | 3 POUCH in 1 CARTON (68180-739-73) / 1 BLISTER PACK in 1 POUCH / 1 KIT in 1 BLISTER PACK * 21 TABLET, FILM COATED in 1 BLISTER PACK (68180-787-74) * 7 TABLET in 1 BLISTER PACK (68180-794-74)Marketed from Dec 10, 2024 |
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)
- Enskyce
- Generic name (nonproprietary)
- desogestrel 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 201887
- Marketing start
- Listing expires
- Identifiers
- Product ID 68180-739_fe68188c-4369-4e86-9bb4-2b5d01ff2594SPL ID fe68188c-4369-4e86-9bb4-2b5d01ff2594SPL set ID 799fa1d8-4e7b-4b5e-844d-d638896a4b02RxCUI 240707, 748797, 749848, 1422081UPC 0368180739715
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
N468180073973followed by a unit qualifier and the quantityPackage 68180-0739-73. 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 Enskyce 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. Table 1 lists the typical accidental pregnancy rates for users of combined oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, the IUD, and the Norplant System depends upon the reliability with which they are used. Correct and consistent use of these methods can result in lower failure rates. In a clinical trial with Enskyce, 1,195 subjects completed 11,656 cycles and a total of 10 pregnancies were reported. This represents…
Excerpt only. Read the full label for complete information.
About NDC 68180-739
- What is NDC 68180-739?
- 68180-739 is the product NDC for Enskyce 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?
- Enskyce (Desogestrel 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 Enskyce?
- 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.