oxcarbazepine

Generic: oxcarbazepine

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

Drug Facts

Product Profile

Brand Name oxcarbazepine
Generic Name oxcarbazepine
Labeler remedyrepack inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

oxcarbazepine 300 mg/1

Manufacturer
REMEDYREPACK INC.

Identifiers & Regulatory

Product NDC 70518-3921
Product ID 70518-3921_3646eab6-6f97-cf2b-e063-6294a90a1b93
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA215939
Listing Expiration 2026-12-31
Marketing Start 2023-11-22

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 705183921
Hyphenated Format 70518-3921

Supplemental Identifiers

RxCUI
312137
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 ANDA215939 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 300 mg/1
source: ndc
Packaging
  • 100 POUCH in 1 BOX (70518-3921-0) / 1 TABLET, FILM COATED in 1 POUCH (70518-3921-1)
source: ndc

Packages (1)

70518-3921-0 100 POUCH in 1 BOX (70518-3921-0) / 1 TABLET, FILM COATED in 1 POUCH (70518-3921-1)

Ingredients (1)

oxcarbazepine (300 mg/1)

Linked Drug Pages (1)

Oxcarbazepine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "3646eab6-6f97-cf2b-e063-6294a90a1b93", "openfda": {"nui": ["N0000175753", "N0000008486"], "unii": ["VZI5B1W380"], "rxcui": ["312137"], "spl_set_id": ["0abe9478-4084-286d-e063-6294a90a9ba7"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "pharm_class_epc": ["Anti-epileptic Agent [EPC]"], "manufacturer_name": ["REMEDYREPACK INC."]}, "finished": true, "packaging": [{"sample": false, "description": "100 POUCH in 1 BOX (70518-3921-0)  / 1 TABLET, FILM COATED in 1 POUCH (70518-3921-1)", "package_ndc": "70518-3921-0", "marketing_start_date": "20231122"}], "brand_name": "Oxcarbazepine", "product_id": "70518-3921_3646eab6-6f97-cf2b-e063-6294a90a1b93", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Anti-epileptic Agent [EPC]", "Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "70518-3921", "generic_name": "Oxcarbazepine", "labeler_name": "REMEDYREPACK INC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Oxcarbazepine", "active_ingredients": [{"name": "OXCARBAZEPINE", "strength": "300 mg/1"}], "application_number": "ANDA215939", "marketing_category": "ANDA", "marketing_start_date": "20231122", "listing_expiration_date": "20261231"}