oxcarbazepine

Generic: oxcarbazepine

Labeler: ascend laboratories, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name oxcarbazepine
Generic Name oxcarbazepine
Labeler ascend laboratories, llc
Dosage Form SUSPENSION
Routes
ORAL
Active Ingredients

oxcarbazepine 60 mg/mL

Manufacturer
Ascend Laboratories, LLC

Identifiers & Regulatory

Product NDC 67877-532
Product ID 67877-532_1f629ae0-1f1c-4bce-b216-af26d84d24c6
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA213183
Listing Expiration 2026-12-31
Marketing Start 2020-01-01

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 67877532
Hyphenated Format 67877-532

Supplemental Identifiers

RxCUI
283536
UPC
0367877532585
UNII
VZI5B1W380
NUI
N0000175753 N0000008486

Packaging Origin

Original Packager
true

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 ANDA213183 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 60 mg/mL
source: ndc
Packaging
  • 250 mL in 1 BOTTLE (67877-532-58)
source: ndc

Packages (1)

67877-532-58 250 mL in 1 BOTTLE (67877-532-58)

Ingredients (1)

oxcarbazepine (60 mg/mL)

Linked Drug Pages (1)

Oxcarbazepine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "1f629ae0-1f1c-4bce-b216-af26d84d24c6", "openfda": {"nui": ["N0000175753", "N0000008486"], "upc": ["0367877532585"], "unii": ["VZI5B1W380"], "rxcui": ["283536"], "spl_set_id": ["3f36f519-c30c-4929-afa0-9844dc531e3f"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "pharm_class_epc": ["Anti-epileptic Agent [EPC]"], "manufacturer_name": ["Ascend Laboratories, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "250 mL in 1 BOTTLE (67877-532-58)", "package_ndc": "67877-532-58", "marketing_start_date": "20200101"}], "brand_name": "Oxcarbazepine", "product_id": "67877-532_1f629ae0-1f1c-4bce-b216-af26d84d24c6", "dosage_form": "SUSPENSION", "pharm_class": ["Anti-epileptic Agent [EPC]", "Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "67877-532", "generic_name": "Oxcarbazepine", "labeler_name": "Ascend Laboratories, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Oxcarbazepine", "active_ingredients": [{"name": "OXCARBAZEPINE", "strength": "60 mg/mL"}], "application_number": "ANDA213183", "marketing_category": "ANDA", "marketing_start_date": "20200101", "listing_expiration_date": "20261231"}