Prescription drug · ANDA
Tarina 24 Fe NDC 50102-224
norethindrone acetate and ethinyl estradiol and ferrous fumarate · Kit · Afaxys Pharma, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50102-224-23 | 50102022423 | 3 POUCH in 1 CARTON (50102-224-23) / 1 BLISTER PACK in 1 POUCH (50102-224-21) / 1 KIT in 1 BLISTER PACKMarketed from Jun 15, 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)
- Tarina 24 Fe
- Generic name (nonproprietary)
- norethindrone acetate and ethinyl estradiol and ferrous fumarate
- Dosage form
- Kit
- Labeler
- Afaxys Pharma, LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 207504
- Marketing start
- Listing expires
- Identifiers
- Product ID 50102-224_d26d48bb-0073-49c8-8f9d-ad35a3162653SPL ID d26d48bb-0073-49c8-8f9d-ad35a3162653SPL set ID 557fa655-c40f-4ecb-bd18-4820c7e15e4bRxCUI 259176, 1358762, 1359117, 2107008
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
N450102022423followed by a unit qualifier and the quantityPackage 50102-0224-23. 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)
Tarina 24 Fe is indicated for use by women to prevent pregnancy [see Clinical Studies (14) ] . The efficacy of Tarina 24 Fe in women with a body mass index (BMI) of greater than 35 kg/m 2 has not been evaluated. Tarina 24 Fe is a combination of norethindrone acetate, a progestin, and ethinyl estradiol, an estrogen, indicated for use by women to prevent pregnancy. ( 1 ) The efficacy of Tarina 24 Fe in women with a body mass index (BMI) of greater 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 207504
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 |
|---|---|---|---|---|
| Aurovela 24 Fenorethindrone acetate and ethinyl estradiol and ferrous fumarate | — | Kit | Aurobindo Pharma Limited | 65862-934 |