Prescription drug · ANDA
Kalliga NDC 65862-887
desogestrel and ethinyl estradiol · Kit · Aurobindo Pharma Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 65862-887-88 | 65862088788 | 3 POUCH in 1 CARTON (65862-887-88) / 1 BLISTER PACK in 1 POUCH / 1 KIT in 1 BLISTER PACKMarketed from May 17, 2017 | |
| 65862-887-92 | 65862088792 | 6 POUCH in 1 CARTON (65862-887-92) / 1 BLISTER PACK in 1 POUCH (65862-887-28) / 1 KIT in 1 BLISTER PACKMarketed from May 17, 2017 |
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)
- Kalliga
- Generic name (nonproprietary)
- desogestrel and ethinyl estradiol
- Dosage form
- Kit
- Labeler
- Aurobindo Pharma Limited
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 207081
- Marketing start
- Listing expires
- Identifiers
- Product ID 65862-887_e3758444-132a-4c4d-b713-cc5f3b990288SPL ID e3758444-132a-4c4d-b713-cc5f3b990288SPL set ID dbe9f9ab-2e38-49e3-bb1f-c8a12d03076aRxCUI 240707, 748797, 749848, 1923421
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
N465862088788followed by a unit qualifier and the quantityPackage 65862-0887-88. 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 Kalliga TM 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 Kalliga TM , 1,195 subjects completed 11,656 cycles and a total of 10 pregnancies were reported. This rep…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 207081
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.