NDC codes

FDA NDC Directory
Product NDC (as listed)72865-285Labeler and product segments. Claims need a package NDC.
Product NDC at billing width72865-0285Add 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
72865-285-0172865028501100 TABLET, FILM COATED in 1 BOTTLE (72865-285-01)Marketed from Jul 18, 2024
72865-285-0572865028505500 TABLET, FILM COATED in 1 BOTTLE (72865-285-05)Marketed from Jul 18, 2024

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)
Oxcarbazepine
Generic name (nonproprietary)
oxcarbazepine
Active ingredients
Oxcarbazepine — 600 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Labeler
XLCare Pharmaceuticals Inc.NDC labeler code 72865
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 215939
Marketing start
Listing expires
Other FDA classes
Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)
Identifiers
Product ID 72865-285_1d5c79a3-4eec-f65b-e063-6294a90aab4fSPL ID 1d5c79a3-4eec-f65b-e063-6294a90aab4fSPL set ID 9f5d17e4-ca68-48e2-9e87-d3ab1c59aa93RxCUI 312136, 312137, 312138UNII VZI5B1W380UPC 0372865284018, 0372865285015, 0372865283011
Pharmacologic class
Anti-epileptic Agent

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 HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N472865028501 followed by a unit qualifier and the quantity

Package 72865-0285-01. 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

Current FDA label (SPL), effective .

Indications (excerpt from the label)

Oxcarbazepine tablets are indicated for use as monotherapy or adjunctive therapy in the treatment of partial-onset seizures in adults and as monotherapy in the treatment of partial-onset seizures in pediatric patients aged 4 years and above, and as adjunctive therapy in pediatric patients aged 2 years and above with partial-onset seizures. Oxcarbazepine tablets are indicated for: • Adults: Monotherapy or adjunctive therapy in the treatment of partial-onset seizures • Pediatrics: - Monotherapy in the treatment of partial-onset seizures in children 4 to 16 years - Adjunctive therapy in the treatment of partial-onset seizures in children 2 to 16 years ( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 72865-285

What is NDC 72865-285?
72865-285 is the product NDC for Oxcarbazepine, Oxcarbazepine 600 mg/1 tablet, film coated, listed with the FDA by XLCare Pharmaceuticals Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Oxcarbazepine.
What is the active ingredient?
Oxcarbazepine.
Who is the labeler?
XLCare Pharmaceuticals Inc., NDC labeler code 72865. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Oxcarbazepine?
118 other product NDCs are listed under this name. See all Oxcarbazepine NDCs.
Is there a related HCPCS / J-code?
Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Oxcarbazepine NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
OxcarbazepineOxcarbazepine 600 mg/1Tablet, Film coatedOralZameer Pharmaceuticals LLC90096-17390096-0173-01
OxcarbazepineOxcarbazepine 150 mg/1Tablet, Film coatedOralZameer Pharmaceuticals LLC90096-17190096-0171-01
OxcarbazepineOxcarbazepine 300 mg/1Tablet, Film coatedOralZameer Pharmaceuticals LLC90096-17290096-0172-01
OxcarbazepineOxcarbazepine 300 mg/5mLSuspensionOralNovadoz Pharmaceuticals LLC72205-35472205-0354-85
OxcarbazepineOxcarbazepine 600 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-466470518-4664-0070518-4664-01
OxcarbazepineOxcarbazepine 300 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-466370518-4663-0070518-4663-01
OxcarbazepineOxcarbazepine 300 mg/1Tablet, Film coatedOralCoupler LLC67046-208467046-2084-03
OxcarbazepineOxcarbazepine 300 mg/1Tablet, Film coatedOralCoupler LLC67046-086867046-0868-03
OxcarbazepineOxcarbazepine 600 mg/1Tablet, Film coatedOralCoupler LLC67046-017967046-0179-03
OxcarbazepineOxcarbazepine 150 mg/1Tablet, Film coatedOralMajor Pharmaceuticals0904-759300904-7593-61

All 119 Oxcarbazepine NDCs

Other NDCs under ANDA 215939

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

FDA NDC Directory listings under ANDA 215939
ProductStrengthForm · routeLabelerProduct NDC
OxcarbazepineOxcarbazepine 150 mg/1Tablet, Film coatedOralCamber Pharmaceuticals, Inc.31722-023
OxcarbazepineOxcarbazepine 300 mg/1Tablet, Film coatedOralCamber Pharmaceuticals, Inc.31722-024
OxcarbazepineOxcarbazepine 600 mg/1Tablet, Film coatedOralCamber Pharmaceuticals, Inc.31722-025
OxcarbazepineOxcarbazepine 150 mg/1Tablet, Film coatedOralAvPAK50268-679
OxcarbazepineOxcarbazepine 300 mg/1Tablet, Film coatedOralAvPAK50268-680
OxcarbazepineOxcarbazepine 600 mg/1Tablet, Film coatedOralAvPAK50268-681
OxcarbazepineOxcarbazepine 300 mg/1Tablet, Film coatedOralCardinal Health 107, LLC55154-2138
OxcarbazepineOxcarbazepine 150 mg/1Tablet, Film coatedOralCardinal Health 107, LLC55154-2139
OxcarbazepineOxcarbazepine 150 mg/1Tablet, Film coatedOralAmerican Health Packaging60687-711
OxcarbazepineOxcarbazepine 300 mg/1Tablet, Film coatedOralAmerican Health Packaging60687-722
OxcarbazepineOxcarbazepine 600 mg/1Tablet, Film coatedOralAmerican Health Packaging60687-733
OxcarbazepineOxcarbazepine 300 mg/1Tablet, Film coatedOralCoupler LLC67046-2084
OxcarbazepineOxcarbazepine 300 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-3921
OxcarbazepineOxcarbazepine 600 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-3925
OxcarbazepineOxcarbazepine 150 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-3940
OxcarbazepineOxcarbazepine 300 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-2548
OxcarbazepineOxcarbazepine 300 mg/1Tablet, Film coatedOralNorthStar RxLLC72603-271
OxcarbazepineOxcarbazepine 600 mg/1Tablet, Film coatedOralNorthStar RxLLC72603-272
OxcarbazepineOxcarbazepine 150 mg/1Tablet, Film coatedOralXLCare Pharmaceuticals Inc.72865-283
OxcarbazepineOxcarbazepine 300 mg/1Tablet, Film coatedOralXLCare Pharmaceuticals Inc.72865-284

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