Tri-VyLibra NDC 50102-233

NDC codes

FDA NDC Directory

Product NDC (as listed)50102-233Labeler and product segments. Claims need a package NDC.

Product NDC at billing width50102-0233Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
50102-233-11	50102023311	1 BLISTER PACK in 1 CARTON (50102-233-11) / 1 KIT in 1 BLISTER PACKMarketed from Jul 6, 2016
50102-233-13	50102023313	3 BLISTER PACK in 1 CARTON (50102-233-13) / 1 KIT in 1 BLISTER PACKMarketed from Jul 6, 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
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 205441
Marketing start: Jul 6, 2016
Listing expires: Dec 31, 2026
Identifiers: Product ID 50102-233_8f45527d-e6cf-4eda-ac01-29618a778122SPL ID 8f45527d-e6cf-4eda-ac01-29618a778122SPL set ID f59acc3e-21d9-4fa3-ad52-d77225739e1aRxCUI 240128, 406396, 687424, 748797, 749784, 1994764

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

N450102023311 followed by a unit qualifier and the quantity

Package 50102-0233-11. 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 Feb 2, 2024. This label includes a boxed warning.

Indications (excerpt from the label)

Tri-VyLibra is combination of norgestimate, a progestin, and ethinyl estradiol, an estrogen, indicated for use by females of reproductive potential to prevent pregnancy. ( 1.1 ) Tri-VyLibra is indicated for the treatment of moderate acne vulgaris in females at least 15 years of age, who have no known contraindications to oral contraceptive therapy and have achieved menarche. Tri-VyLibra should be used for the treatment of acne only if the patient desires an oral contraceptive for birth control. ( 1.2 ) 1.1 Oral Contraceptive Tri-VyLibra tablets are indicated for use by females of reproductive potential to prevent pregnancy [see Clinical Studies (14) ] . 1.2 Acne Tri-VyLibra is indicated for …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 205441

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 205441
Product	Strength	Form · route	Labeler	Product NDC
Tri-Milinorgestimate and ethinyl estradiol	—	Kit	Aurobindo Pharma Limited	65862-777