Prescription drug · ANDA
Charlotte 24Fe NDC 68462-852
norethindrone acetate and ethinyl estradiol and ferrous fumarate · Kit · Glenmark Pharmaceuticals Inc., USA
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68462-852-29 | 68462085229 | 3 BLISTER PACK in 1 CARTON (68462-852-29) / 1 KIT in 1 BLISTER PACKMarketed from Feb 20, 2020 |
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)
- Charlotte 24Fe
- Generic name (nonproprietary)
- norethindrone acetate and ethinyl estradiol and ferrous fumarate
- Dosage form
- Kit
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 210369
- Marketing start
- Listing expires
- Identifiers
- Product ID 68462-852_d5dfc9ba-16e2-4a8f-babf-b4a159785d47SPL ID d5dfc9ba-16e2-4a8f-babf-b4a159785d47SPL set ID b01f8921-8844-43e6-8167-561ff03c21efRxCUI 259176, 1426288, 1426600, 2280761UPC 0368462852293
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
N468462085229followed by a unit qualifier and the quantityPackage 68462-0852-29. 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)
Charlotte 24 Fe is indicated for use by females of reproductive age to prevent pregnancy [see Clinical Studies ( 14 )] . The efficacy of Charlotte 24 Fe in women with a body mass index (BMI) of more than 35 kg/m 2 has not been evaluated. • Charlotte 24 Fe is a combination of norethindrone acetate, 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 of more than 35 kg/m 2 has not been evaluated ( 1 , 8.8 )
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 210369
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 and ferrous fumarate | — | Kit | Glenmark Pharmaceuticals Inc., USA | 68462-376 |