oxcarbazepine

Generic: oxcarbazepine

Labeler: biocon pharma inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name oxcarbazepine
Generic Name oxcarbazepine
Labeler biocon pharma inc.
Dosage Form SUSPENSION
Routes
ORAL
Active Ingredients

oxcarbazepine 60 mg/mL

Manufacturer
Biocon Pharma Inc.

Identifiers & Regulatory

Product NDC 70377-117
Product ID 70377-117_f99a88aa-8790-c34c-72d2-aa7a7dec80af
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA218278
Listing Expiration 2026-12-31
Marketing Start 2024-05-31

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 70377117
Hyphenated Format 70377-117

Supplemental Identifiers

RxCUI
283536
UPC
0370377117114
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 ANDA218278 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 60 mg/mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (70377-117-11) / 250 mL in 1 BOTTLE
source: ndc

Packages (1)

70377-117-11 1 BOTTLE in 1 CARTON (70377-117-11) / 250 mL in 1 BOTTLE

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": "f99a88aa-8790-c34c-72d2-aa7a7dec80af", "openfda": {"nui": ["N0000175753", "N0000008486"], "upc": ["0370377117114"], "unii": ["VZI5B1W380"], "rxcui": ["283536"], "spl_set_id": ["62dfed1d-4c5b-446d-97b3-bad9c33959ff"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "pharm_class_epc": ["Anti-epileptic Agent [EPC]"], "manufacturer_name": ["Biocon Pharma Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (70377-117-11)  / 250 mL in 1 BOTTLE", "package_ndc": "70377-117-11", "marketing_start_date": "20240531"}], "brand_name": "OXCARBAZEPINE", "product_id": "70377-117_f99a88aa-8790-c34c-72d2-aa7a7dec80af", "dosage_form": "SUSPENSION", "pharm_class": ["Anti-epileptic Agent [EPC]", "Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "70377-117", "generic_name": "OXCARBAZEPINE", "labeler_name": "Biocon Pharma Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "OXCARBAZEPINE", "active_ingredients": [{"name": "OXCARBAZEPINE", "strength": "60 mg/mL"}], "application_number": "ANDA218278", "marketing_category": "ANDA", "marketing_start_date": "20240531", "listing_expiration_date": "20261231"}