NDC codes

FDA NDC Directory
Product NDC (as listed)68788-7866Labeler and product segments. Claims need a package NDC.
Product NDC at billing width68788-7866Add 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
68788-7866-36878878660330 TABLET, FILM COATED in 1 BOTTLE (68788-7866-3)Marketed from Feb 15, 2021
68788-7866-66878878660660 TABLET, FILM COATED in 1 BOTTLE (68788-7866-6)Marketed from Feb 15, 2021
68788-7866-96878878660990 TABLET, FILM COATED in 1 BOTTLE (68788-7866-9)Marketed from Feb 15, 2021

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)
Oxcarbazepine
Generic name (nonproprietary)
oxcarbazepine
Active ingredients
Oxcarbazepine — 600 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Labeler
Preferred Pharmaceuticals Inc.NDC labeler code 68788
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 078069
Marketing start
Listing expires
Other FDA classes
Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)
Identifiers
Product ID 68788-7866_549f1700-86c6-4e21-9391-08de6ef3cbf2SPL ID 549f1700-86c6-4e21-9391-08de6ef3cbf2SPL set ID e156339c-f79e-4a20-b9da-f50bea948213RxCUI 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

N468788786603 followed by a unit qualifier and the quantity

Package 68788-7866-03. 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: o Monotherapy in the treatment of partial-onset seizures in children 4–16 years o Adjunctive therapy in the treatment of partial-onset seizures in children 2–16 years ()

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 68788-7866

What is NDC 68788-7866?
68788-7866 is the product NDC for Oxcarbazepine, Oxcarbazepine 600 mg/1 tablet, film coated, listed with the FDA by Preferred Pharmaceuticals Inc.. It has 3 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?
Preferred Pharmaceuticals Inc., NDC labeler code 68788. 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 078069

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

FDA NDC Directory listings under ANDA 078069
ProductStrengthForm · routeLabelerProduct NDC
OxcarbazepineOxcarbazepine 300 mg/1Tablet, Film coatedOralCardinal Health 107, LLC55154-4320
OxcarbazepineOxcarbazepine 150 mg/1Tablet, Film coatedOralCardinal Health 107, LLC55154-4323
OxcarbazepineOxcarbazepine 150 mg/1Tablet, Film coatedOralMajor Pharmaceuticals0904-7593
OxcarbazepineOxcarbazepine 300 mg/1Tablet, Film coatedOralMajor Pharmaceuticals0904-7594
OxcarbazepineOxcarbazepine 300 mg/1Tablet, Film coatedOralBryant Ranch Prepack63629-9186
OxcarbazepineOxcarbazepine 600 mg/1Tablet, Film coatedOralMajor Pharmaceuticals0904-7595
OxcarbazepineOxcarbazepine 150 mg/1Tablet, Film coatedOralCoupler LLC67046-1597
OxcarbazepineOxcarbazepine 300 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-0090
OxcarbazepineOxcarbazepine 600 mg/1Tablet, Film coatedOralBryant Ranch Prepack63629-6834
OxcarbazepineOxcarbazepine 300 mg/1Tablet, Film coatedOralBryant Ranch Prepack72162-1594
OxcarbazepineOxcarbazepine 600 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-4664
OxcarbazepineOxcarbazepine 300 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-4663
OxcarbazepineOxcarbazepine 150 mg/1Tablet, Film coatedOralMajor Pharmaceuticals0904-7262
OxcarbazepineOxcarbazepine 150 mg/1Tablet, Film coatedOralBreckenridge Pharmaceutical, Inc.51991-053
OxcarbazepineOxcarbazepine 300 mg/1Tablet, Film coatedOralBreckenridge Pharmaceutical, Inc.51991-054
OxcarbazepineOxcarbazepine 300 mg/1Tablet, Film coatedOralMajor Pharmaceuticals0904-7263
OxcarbazepineOxcarbazepine 600 mg/1Tablet, Film coatedOralBreckenridge Pharmaceutical, Inc.51991-055
OxcarbazepineOxcarbazepine 600 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-4465
OxcarbazepineOxcarbazepine 150 mg/1Tablet, Film coatedOralBreckenridge Pharmaceutical, Inc.51991-292
OxcarbazepineOxcarbazepine 300 mg/1Tablet, Film coatedOralBreckenridge Pharmaceutical, Inc.51991-293

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