oxcarbazepine

Generic: oxcarbazepine

Labeler: camber pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

oxcarbazepine 300 mg/1

Manufacturer
Camber Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 31722-024
Product ID 31722-024_4998217b-01c6-d647-e063-6294a90a2ff9
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA215939
Listing Expiration 2027-12-31
Marketing Start 2022-01-11

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 31722024
Hyphenated Format 31722-024

Supplemental Identifiers

RxCUI
312136 312137 312138
UPC
0331722023054 0331722024051 0331722025058
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 ANDA215939 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 300 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (31722-024-01)
  • 500 TABLET, FILM COATED in 1 BOTTLE (31722-024-05)
  • 1000 TABLET, FILM COATED in 1 BOTTLE (31722-024-10)
  • 10 BLISTER PACK in 1 CARTON (31722-024-31) / 10 TABLET, FILM COATED in 1 BLISTER PACK
source: ndc

Packages (4)

31722-024-01 100 TABLET, FILM COATED in 1 BOTTLE (31722-024-01) 31722-024-05 500 TABLET, FILM COATED in 1 BOTTLE (31722-024-05) 31722-024-10 1000 TABLET, FILM COATED in 1 BOTTLE (31722-024-10) 31722-024-31 10 BLISTER PACK in 1 CARTON (31722-024-31) / 10 TABLET, FILM COATED in 1 BLISTER PACK

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": "4998217b-01c6-d647-e063-6294a90a2ff9", "openfda": {"nui": ["N0000175753", "N0000008486"], "upc": ["0331722023054", "0331722024051", "0331722025058"], "unii": ["VZI5B1W380"], "rxcui": ["312136", "312137", "312138"], "spl_set_id": ["fe49a773-562c-4da6-96b7-bba52f4d61e2"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "pharm_class_epc": ["Anti-epileptic Agent [EPC]"], "manufacturer_name": ["Camber Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (31722-024-01)", "package_ndc": "31722-024-01", "marketing_start_date": "20220111"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (31722-024-05)", "package_ndc": "31722-024-05", "marketing_start_date": "20230310"}, {"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (31722-024-10)", "package_ndc": "31722-024-10", "marketing_start_date": "20230310"}, {"sample": false, "description": "10 BLISTER PACK in 1 CARTON (31722-024-31)  / 10 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "31722-024-31", "marketing_start_date": "20220111"}], "brand_name": "Oxcarbazepine", "product_id": "31722-024_4998217b-01c6-d647-e063-6294a90a2ff9", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Anti-epileptic Agent [EPC]", "Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "31722-024", "generic_name": "Oxcarbazepine", "labeler_name": "Camber Pharmaceuticals, 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": "20220111", "listing_expiration_date": "20271231"}