oxcarbazepine

Generic: oxcarbazepine

Labeler: chartwell governmental & specialty rx, llc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name oxcarbazepine
Generic Name oxcarbazepine
Labeler chartwell governmental & specialty rx, llc.
Dosage Form SUSPENSION
Routes
ORAL
Active Ingredients

oxcarbazepine 300 mg/5mL

Manufacturer
Chartwell Governmental & Specialty RX, LLC.

Identifiers & Regulatory

Product NDC 68999-841
Product ID 68999-841_46dc543c-d51b-4dee-e063-6394a90a1856
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212428
Listing Expiration 2026-12-31
Marketing Start 2021-09-21

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 68999841
Hyphenated Format 68999-841

Supplemental Identifiers

RxCUI
283536
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 ANDA212428 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 300 mg/5mL
source: ndc
Packaging
  • 2 TRAY in 1 BOX (68999-841-24) / 10 CUP in 1 TRAY / 5 mL in 1 CUP (68999-841-45)
source: ndc

Packages (1)

68999-841-24 2 TRAY in 1 BOX (68999-841-24) / 10 CUP in 1 TRAY / 5 mL in 1 CUP (68999-841-45)

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": "46dc543c-d51b-4dee-e063-6394a90a1856", "openfda": {"nui": ["N0000175753", "N0000008486"], "unii": ["VZI5B1W380"], "rxcui": ["283536"], "spl_set_id": ["e74bb389-8426-4ffc-a14b-a5990de6d0d4"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "pharm_class_epc": ["Anti-epileptic Agent [EPC]"], "manufacturer_name": ["Chartwell Governmental & Specialty RX, LLC."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2 TRAY in 1 BOX (68999-841-24)  / 10 CUP in 1 TRAY / 5 mL in 1 CUP (68999-841-45)", "package_ndc": "68999-841-24", "marketing_start_date": "20251219"}], "brand_name": "Oxcarbazepine", "product_id": "68999-841_46dc543c-d51b-4dee-e063-6394a90a1856", "dosage_form": "SUSPENSION", "pharm_class": ["Anti-epileptic Agent [EPC]", "Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "68999-841", "generic_name": "Oxcarbazepine", "labeler_name": "Chartwell Governmental & Specialty RX, LLC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Oxcarbazepine", "active_ingredients": [{"name": "OXCARBAZEPINE", "strength": "300 mg/5mL"}], "application_number": "ANDA212428", "marketing_category": "ANDA", "marketing_start_date": "20210921", "listing_expiration_date": "20261231"}