oxcarbazepine

Generic: oxcarbazepine

Labeler: amneal pharmaceuticals llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name oxcarbazepine
Generic Name oxcarbazepine
Labeler amneal pharmaceuticals llc
Dosage Form SUSPENSION
Routes
ORAL
Active Ingredients

oxcarbazepine 300 mg/5mL

Manufacturer
Amneal Pharmaceuticals LLC

Identifiers & Regulatory

Product NDC 65162-649
Product ID 65162-649_1ec65e90-ec0e-431f-a985-d7cb39694492
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202961
Listing Expiration 2026-12-31
Marketing Start 2012-06-04

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 65162649
Hyphenated Format 65162-649

Supplemental Identifiers

RxCUI
283536
UPC
0365162649789
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 ANDA202961 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 300 mg/5mL
source: ndc
Packaging
  • 10 CUP, UNIT-DOSE in 1 TRAY (65162-649-48) / 5 mL in 1 CUP, UNIT-DOSE (65162-649-43)
  • 1 BOTTLE in 1 CARTON (65162-649-78) / 250 mL in 1 BOTTLE
source: ndc

Packages (2)

65162-649-48 10 CUP, UNIT-DOSE in 1 TRAY (65162-649-48) / 5 mL in 1 CUP, UNIT-DOSE (65162-649-43) 65162-649-78 1 BOTTLE in 1 CARTON (65162-649-78) / 250 mL in 1 BOTTLE

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": "1ec65e90-ec0e-431f-a985-d7cb39694492", "openfda": {"nui": ["N0000175753", "N0000008486"], "upc": ["0365162649789"], "unii": ["VZI5B1W380"], "rxcui": ["283536"], "spl_set_id": ["2515391e-3a88-4226-92e5-f641c8409fe5"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "pharm_class_epc": ["Anti-epileptic Agent [EPC]"], "manufacturer_name": ["Amneal Pharmaceuticals LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 CUP, UNIT-DOSE in 1 TRAY (65162-649-48)  / 5 mL in 1 CUP, UNIT-DOSE (65162-649-43)", "package_ndc": "65162-649-48", "marketing_start_date": "20120604"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (65162-649-78)  / 250 mL in 1 BOTTLE", "package_ndc": "65162-649-78", "marketing_start_date": "20120604"}], "brand_name": "Oxcarbazepine", "product_id": "65162-649_1ec65e90-ec0e-431f-a985-d7cb39694492", "dosage_form": "SUSPENSION", "pharm_class": ["Anti-epileptic Agent [EPC]", "Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "65162-649", "generic_name": "Oxcarbazepine", "labeler_name": "Amneal Pharmaceuticals LLC", "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": "20120604", "listing_expiration_date": "20261231"}