NDC codes

FDA NDC Directory
Product NDC (as listed)68094-123Labeler and product segments. Claims need a package NDC.
Product NDC at billing width68094-0123Add 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
68094-123-6268094012362680940123623 TRAY in 1 CASE (68094-123-62) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (68094-123-59)Marketed from Sep 13, 2017

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/5mL
Dosage form
Suspension
Route
Oral
Labeler
Precision Dose, Inc.NDC labeler code 68094
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 202961
Marketing start
Listing expires
Other FDA classes
Decreased Central Nervous System Disorganized Electrical Activity (Physiologic effect)
Identifiers
Product ID 68094-123_43ea970d-701d-409d-b9a1-4e0c171ede4dSPL ID 43ea970d-701d-409d-b9a1-4e0c171ede4dSPL set ID 636fc847-b3d2-4255-a959-d75499fdb198RxCUI 283536UNII 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

N468094012362 followed by a unit qualifier and the quantity

Package 68094-0123-62. 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 oral suspension is 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 oral suspension is 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 68094-123

What is NDC 68094-123?
68094-123 is the product NDC for Oxcarbazepine, Oxcarbazepine 300 mg/5mL suspension, listed with the FDA by Precision Dose, Inc.. 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?
Precision Dose, Inc., NDC labeler code 68094. 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 150 mg/1Tablet, Film coatedOralZameer Pharmaceuticals LLC90096-17190096-0171-01
OxcarbazepineOxcarbazepine 300 mg/1Tablet, Film coatedOralZameer Pharmaceuticals LLC90096-17290096-0172-01
OxcarbazepineOxcarbazepine 600 mg/1Tablet, Film coatedOralZameer Pharmaceuticals LLC90096-17390096-0173-01
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 202961

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

FDA NDC Directory listings under ANDA 202961
ProductStrengthForm · routeLabelerProduct NDC
OxcarbazepineOxcarbazepine 300 mg/5mLSuspensionOralAmneal Pharmaceuticals LLC65162-649
OxcarbazepineOxcarbazepine 300 mg/5mLSuspensionOralBryant Ranch Prepack72162-2088

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