Prescription drug · ANDA

Oxcarbazepine NDC 63629-3816

Oxcarbazepine 150 mg/1 · Tablet, Film coated · Oral · Bryant Ranch Prepack

NDC codes

FDA NDC Directory
Product NDC (as listed)63629-3816Labeler and product segments. Claims need a package NDC.
Product NDC at billing width63629-3816Add 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
63629-3816-16362938160130 TABLET, FILM COATED in 1 BOTTLE (63629-3816-1)Marketed from Jul 28, 2011
63629-3816-26362938160260 TABLET, FILM COATED in 1 BOTTLE (63629-3816-2)Marketed from Oct 14, 2008
63629-3816-36362938160390 TABLET, FILM COATED in 1 BOTTLE (63629-3816-3)Marketed from Aug 6, 2012

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 — 150 mg/1
Dosage form
Tablet, Film coated
Route
Oral
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 63629-3816_e1e371c0-49d4-401e-8e7c-b953f579480eSPL ID e1e371c0-49d4-401e-8e7c-b953f579480eSPL set ID 78f196d4-110e-45b1-813a-725f52c1a4ebRxCUI 312136UNII 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

N463629381601 followed by a unit qualifier and the quantity

Package 63629-3816-01. 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 4–16 years - Adjunctive therapy in the treatment of partial-onset seizures in children 2–16 years ( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

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 600 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-4465
OxcarbazepineOxcarbazepine 150 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-4480
OxcarbazepineOxcarbazepine 300 mg/1Tablet, Film coatedOralGolden State Medical Supply, Inc.60429-062
OxcarbazepineOxcarbazepine 150 mg/1Tablet, Film coatedOralGolden State Medical Supply, Inc.60429-061
OxcarbazepineOxcarbazepine 600 mg/1Tablet, Film coatedOralGolden State Medical Supply, Inc.60429-063
OxcarbazepineOxcarbazepine 150 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-2253
OxcarbazepineOxcarbazepine 150 mg/1Tablet, Film coatedOralMajor Pharmaceuticals0904-7262
OxcarbazepineOxcarbazepine 600 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-2254
OxcarbazepineOxcarbazepine 300 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-2276
OxcarbazepineOxcarbazepine 300 mg/1Tablet, Film coatedOralMajor Pharmaceuticals0904-7263
OxcarbazepineOxcarbazepine 600 mg/1Tablet, Film coatedOralMajor Pharmaceuticals0904-7264
OxcarbazepineOxcarbazepine 300 mg/1Tablet, Film coatedOralCardinal Health 107, LLC55154-4320
OxcarbazepineOxcarbazepine 150 mg/1Tablet, Film coatedOralCardinal Health 107, LLC55154-4323
OxcarbazepineOxcarbazepine 300 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-2370
OxcarbazepineOxcarbazepine 300 mg/1Tablet, Film coatedOralBryant Ranch Prepack63629-9186
OxcarbazepineOxcarbazepine 600 mg/1Tablet, Film coatedOralBryant Ranch Prepack63629-6834
OxcarbazepineOxcarbazepine 150 mg/1Tablet, Film coatedOralCoupler LLC67046-1597
OxcarbazepineOxcarbazepine 300 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-0090
OxcarbazepineOxcarbazepine 300 mg/1Tablet, Film coatedOralBryant Ranch Prepack72162-1594
OxcarbazepineOxcarbazepine 150 mg/1Tablet, Film coatedOralMajor Pharmaceuticals0904-7593

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