oxcarbazepine

Generic: oxcarbazepine

Labeler: precision dose, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name oxcarbazepine
Generic Name oxcarbazepine
Labeler precision dose, inc.
Dosage Form SUSPENSION
Routes
ORAL
Active Ingredients

oxcarbazepine 300 mg/5mL

Manufacturer
Precision Dose, Inc.

Identifiers & Regulatory

Product NDC 68094-123
Product ID 68094-123_43ea970d-701d-409d-b9a1-4e0c171ede4d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202961
Listing Expiration 2026-12-31
Marketing Start 2017-09-13

Pharmacologic Class

Established (EPC)
anti-epileptic agent [epc]
Physiologic Effect
decreased central nervous system disorganized electrical activity [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68094123
Hyphenated Format 68094-123

Supplemental Identifiers

RxCUI
283536
UNII
VZI5B1W380
NUI
N0000175753 N0000008486

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name oxcarbazepine (source: ndc)
Generic Name oxcarbazepine (source: ndc)
Application Number ANDA202961 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 300 mg/5mL
source: ndc
Packaging
  • 3 TRAY in 1 CASE (68094-123-62) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (68094-123-59)
source: ndc

Packages (1)

68094-123-62 3 TRAY in 1 CASE (68094-123-62) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (68094-123-59)

Ingredients (1)

oxcarbazepine (300 mg/5mL)

Linked Drug Pages (1)

Oxcarbazepine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "43ea970d-701d-409d-b9a1-4e0c171ede4d", "openfda": {"nui": ["N0000175753", "N0000008486"], "unii": ["VZI5B1W380"], "rxcui": ["283536"], "spl_set_id": ["636fc847-b3d2-4255-a959-d75499fdb198"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "pharm_class_epc": ["Anti-epileptic Agent [EPC]"], "manufacturer_name": ["Precision Dose, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "3 TRAY in 1 CASE (68094-123-62)  / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (68094-123-59)", "package_ndc": "68094-123-62", "marketing_start_date": "20170913"}], "brand_name": "Oxcarbazepine", "product_id": "68094-123_43ea970d-701d-409d-b9a1-4e0c171ede4d", "dosage_form": "SUSPENSION", "pharm_class": ["Anti-epileptic Agent [EPC]", "Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "68094-123", "generic_name": "Oxcarbazepine", "labeler_name": "Precision Dose, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Oxcarbazepine", "active_ingredients": [{"name": "OXCARBAZEPINE", "strength": "300 mg/5mL"}], "application_number": "ANDA202961", "marketing_category": "ANDA", "marketing_start_date": "20170913", "listing_expiration_date": "20261231"}