NDC codes

FDA NDC Directory
Product NDC (as listed)63629-2351Labeler and product segments. Claims need a package NDC.
Product NDC at billing width63629-2351Add 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
63629-2351-1636292351013 BLISTER PACK in 1 CARTON (63629-2351-1) / 1 KIT in 1 BLISTER PACKMarketed from Feb 10, 2023

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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-Lo- Estarylla
Generic name (nonproprietary)
norgestimate and ethinyl estradiol
Dosage form
Kit
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 091232
Marketing start
Listing expires
Identifiers
Product ID 63629-2351_026c9eb0-ce11-45a6-92ab-599bb52142bcSPL ID 026c9eb0-ce11-45a6-92ab-599bb52142bcSPL set ID 90f7ab24-7839-4408-9a74-07bb6a79eaccRxCUI 578732, 748797, 749155, 749156, 749157, 1722676

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

N463629235101 followed by a unit qualifier and the quantity

Package 63629-2351-01. 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

Label details couldn’t be retrieved right now. Open the label on DailyMed.

Other NDCs under ANDA 091232

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

FDA NDC Directory listings under ANDA 091232
ProductStrengthForm · routeLabelerProduct NDC
Tri-Lo- Estaryllanorgestimate and ethinyl estradiol—KitXiromed, LLC.70700-120
Norgestimate and Ethinyl Estradiol—KitAvKARE42291-565

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