Prescription drug · ANDA
Tri-VyLibra Lo NDC 50102-231
norgestimate and ethinyl estradiol · Kit · Afaxys Pharma, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50102-231-13 | 50102023113 | 3 PACKAGE in 1 CARTON (50102-231-13) / 1 BLISTER PACK in 1 PACKAGE (50102-231-11) / 1 KIT in 1 BLISTER PACK (50102-231-01)Marketed from Nov 4, 2016 |
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)
- Tri-VyLibra Lo
- Generic name (nonproprietary)
- norgestimate and ethinyl estradiol
- Dosage form
- Kit
- Labeler
- Afaxys Pharma, LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 205762
- Marketing start
- Listing expires
- Identifiers
- Product ID 50102-231_bb0e872b-05ee-4e30-bc1f-808f2c533e5dSPL ID bb0e872b-05ee-4e30-bc1f-808f2c533e5dSPL set ID bd51a08e-cd45-4315-9bca-41794450ef16RxCUI 578732, 748797, 749155, 749156, 749157, 2104192
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
N450102023113followed by a unit qualifier and the quantityPackage 50102-0231-13. 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)
Tri-VyLibra Lo (norgestimate and ethinyl estradiol tablets) is an estrogen/progestin COC, indicated for use by women to prevent pregnancy. ( 1.1 ) 1.1 Oral Contraception Tri-VyLibra Lo (norgestimate and ethinyl estradiol tablets) is indicated for use by females of reproductive potential to prevent pregnancy [see Clinical Studies (14) ] .
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 205762
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 |
|---|---|---|---|---|
| Tri-Lo-Milinorgestimate and ethinyl estradiol | — | Kit | Aurobindo Pharma Limited | 65862-778 |
| Tri-Lo-Milinorgestimate and ethinyl estradiol | — | Kit | Proficient Rx LP | 71205-746 |
- openFDA data updated
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Reference information only. Verify codes and billing rules against the applicable payer and official source before submitting a claim. How Med-Code handles data.