What is NDC 50268-680?

50268-680 is the product NDC for Oxcarbazepine, Oxcarbazepine 300 mg/1 tablet, film coated, listed with the FDA by AvPAK. It has 1 package NDC, shown above in 10- and 11-digit form.

AvPAK, NDC labeler code 50268. 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.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Oxcarbazepine NDC 50268-680 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)50268-680Labeler and product segments. Claims need a package NDC.

Product NDC at billing width50268-0680Add 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
50268-680-15	50268068015	50 BLISTER PACK in 1 BOX (50268-680-15) / 1 TABLET, FILM COATED in 1 BLISTER PACK (50268-680-11)Marketed from Jun 7, 2023

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 — 300 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: AvPAKNDC labeler code 50268
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 215939
Marketing start: Jun 7, 2023
Listing expires: Dec 31, 2026
Other FDA classes: Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)
Identifiers: Product ID 50268-680_2b4c161c-f20b-38d5-e063-6394a90a8a79SPL ID 2b4c161c-f20b-38d5-e063-6394a90a8a79SPL set ID fd8da0e9-d69b-7587-e053-6294a90a33c0RxCUI 312136, 312137, 312138UNII VZI5B1W380
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

N450268068015 followed by a unit qualifier and the quantity

Package 50268-0680-15. 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 Jan 9, 2025.

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 50268-680

What is NDC 50268-680?: 50268-680 is the product NDC for Oxcarbazepine, Oxcarbazepine 300 mg/1 tablet, film coated, listed with the FDA by AvPAK. It has 1 package NDC, 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?: AvPAK, NDC labeler code 50268. 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
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Oxcarbazepine	Oxcarbazepine 300 mg/1	Tablet, Film coatedOral	Zameer Pharmaceuticals LLC	90096-172	90096-0172-01
Oxcarbazepine	Oxcarbazepine 150 mg/1	Tablet, Film coatedOral	Zameer Pharmaceuticals LLC	90096-171	90096-0171-01
Oxcarbazepine	Oxcarbazepine 600 mg/1	Tablet, Film coatedOral	Zameer Pharmaceuticals LLC	90096-173	90096-0173-01
Oxcarbazepine	Oxcarbazepine 300 mg/5mL	SuspensionOral	Novadoz Pharmaceuticals LLC	72205-354	72205-0354-85
Oxcarbazepine	Oxcarbazepine 600 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-4664	70518-4664-0070518-4664-01
Oxcarbazepine	Oxcarbazepine 300 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-4663	70518-4663-0070518-4663-01
Oxcarbazepine	Oxcarbazepine 300 mg/1	Tablet, Film coatedOral	Coupler LLC	67046-2084	67046-2084-03
Oxcarbazepine	Oxcarbazepine 300 mg/1	Tablet, Film coatedOral	Coupler LLC	67046-0868	67046-0868-03
Oxcarbazepine	Oxcarbazepine 600 mg/1	Tablet, Film coatedOral	Coupler LLC	67046-0179	67046-0179-03
Oxcarbazepine	Oxcarbazepine 150 mg/1	Tablet, Film coatedOral	Major Pharmaceuticals	0904-7593	00904-7593-61

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
Product	Strength	Form · route	Labeler	Product NDC
Oxcarbazepine	Oxcarbazepine 600 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-3925
Oxcarbazepine	Oxcarbazepine 300 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-3921
Oxcarbazepine	Oxcarbazepine 150 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-3940
Oxcarbazepine	Oxcarbazepine 150 mg/1	Tablet, Film coatedOral	AvPAK	50268-679
Oxcarbazepine	Oxcarbazepine 600 mg/1	Tablet, Film coatedOral	AvPAK	50268-681
Oxcarbazepine	Oxcarbazepine 150 mg/1	Tablet, Film coatedOral	American Health Packaging	60687-711
Oxcarbazepine	Oxcarbazepine 300 mg/1	Tablet, Film coatedOral	ASCLEMED USA INC.	87063-208
Oxcarbazepine	Oxcarbazepine 300 mg/1	Tablet, Film coatedOral	Cardinal Health 107, LLC	55154-2138
Oxcarbazepine	Oxcarbazepine 300 mg/1	Tablet, Film coatedOral	American Health Packaging	60687-722
Oxcarbazepine	Oxcarbazepine 150 mg/1	Tablet, Film coatedOral	Cardinal Health 107, LLC	55154-2139
Oxcarbazepine	Oxcarbazepine 600 mg/1	Tablet, Film coatedOral	American Health Packaging	60687-733
Oxcarbazepine	Oxcarbazepine 300 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	71335-2548
Oxcarbazepine	Oxcarbazepine 150 mg/1	Tablet, Film coatedOral	Camber Pharmaceuticals, Inc.	31722-023
Oxcarbazepine	Oxcarbazepine 300 mg/1	Tablet, Film coatedOral	Camber Pharmaceuticals, Inc.	31722-024
Oxcarbazepine	Oxcarbazepine 600 mg/1	Tablet, Film coatedOral	Camber Pharmaceuticals, Inc.	31722-025
Oxcarbazepine	Oxcarbazepine 600 mg/1	Tablet, Film coatedOral	XLCare Pharmaceuticals Inc.	72865-285
Oxcarbazepine	Oxcarbazepine 150 mg/1	Tablet, Film coatedOral	XLCare Pharmaceuticals Inc.	72865-283
Oxcarbazepine	Oxcarbazepine 300 mg/1	Tablet, Film coatedOral	XLCare Pharmaceuticals Inc.	72865-284
Oxcarbazepine	Oxcarbazepine 300 mg/1	Tablet, Film coatedOral	Coupler LLC	67046-2084
Oxcarbazepine	Oxcarbazepine 300 mg/1	Tablet, Film coatedOral	NorthStar RxLLC	72603-271

Showing 20 of 22.