NDC codes

FDA NDC Directory
Product NDC (as listed)50102-231Labeler and product segments. Claims need a package NDC.
Product NDC at billing width50102-0231Add 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 NDC11-digit (billing)PackageCopy
50102-231-13501020231133 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
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

N450102023113 followed by a unit qualifier and the quantity

Package 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.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 205762

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

FDA NDC Directory listings under ANDA 205762
ProductStrengthForm · routeLabelerProduct NDC
Tri-Lo-Milinorgestimate and ethinyl estradiolKitAurobindo Pharma Limited65862-778
Tri-Lo-Milinorgestimate and ethinyl estradiolKitProficient Rx LP71205-746

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