Prescription drug · ANDA
Kaitlib Fe NDC 68180-903
norethindrone and ethinyl estradiol · Kit · Lupin Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68180-903-73 | 68180090373 | 3 BLISTER PACK in 1 CARTON (68180-903-73) / 1 KIT in 1 BLISTER PACK * 24 TABLET, CHEWABLE in 1 BLISTER PACK (68180-356-74) * 4 TABLET, CHEWABLE in 1 BLISTER PACK (68180-358-74)Marketed from Feb 7, 2021 |
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)
- Kaitlib Fe
- Generic name (nonproprietary)
- norethindrone and ethinyl estradiol
- Dosage form
- Kit
- Labeler
- Lupin Pharmaceuticals, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 203448
- Marketing start
- Listing expires
- Identifiers
- Product ID 68180-903_23d6a959-fc74-4a2a-8eb9-15735efec545SPL ID 23d6a959-fc74-4a2a-8eb9-15735efec545SPL set ID 4826031b-c2b7-4cd0-a4da-59068bd34430RxCUI 1095223, 1099638, 1607990, 1727521UPC 0368180903710
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
N468180090373followed by a unit qualifier and the quantityPackage 68180-0903-73. 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)
Kaitlib Fe is a combination of norethindrone, a progestin, and ethinyl estradiol, an estrogen, indicated for use by females of reproductive potential to prevent pregnancy. ( 1 ) The efficacy in females of reproductive potential with a body mass index (BMI) of >35 kg/m 2 has not been evaluated. ( 1 , 8.8 ) Kaitlib™ Fe (norethindrone and ethinyl estradiol chewable tablets and ferrous fumarate chewable tablets) is indicated for use by women to prevent pregnancy. The efficacy of Kaitlib Fe in women with a body mass index (BMI) of > 35 kg/m 2 has not been evaluated.
Excerpt only. Read the full label for complete information.