oxcarbazepine

Generic: oxcarbazepine

Labeler: chartwell rx, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

oxcarbazepine 300 mg/5mL

Manufacturer
Chartwell RX, LLC

Identifiers & Regulatory

Product NDC 62135-841
Product ID 62135-841_47e4dcae-6305-e681-e063-6294a90a5359
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212428
Listing Expiration 2027-12-31
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 62135841
Hyphenated Format 62135-841

Supplemental Identifiers

RxCUI
283536
UPC
0362135841546
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
  • 20 CUP, UNIT-DOSE in 1 CARTON (62135-841-24) / 5 mL in 1 CUP, UNIT-DOSE (62135-841-45)
  • 250 mL in 1 BOTTLE (62135-841-54)
source: ndc

Packages (2)

62135-841-24 20 CUP, UNIT-DOSE in 1 CARTON (62135-841-24) / 5 mL in 1 CUP, UNIT-DOSE (62135-841-45) 62135-841-54 250 mL in 1 BOTTLE (62135-841-54)

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": "47e4dcae-6305-e681-e063-6294a90a5359", "openfda": {"nui": ["N0000175753", "N0000008486"], "upc": ["0362135841546"], "unii": ["VZI5B1W380"], "rxcui": ["283536"], "spl_set_id": ["c2affa00-1d57-4d85-8db3-745191b4714d"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "pharm_class_epc": ["Anti-epileptic Agent [EPC]"], "manufacturer_name": ["Chartwell RX, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "20 CUP, UNIT-DOSE in 1 CARTON (62135-841-24)  / 5 mL in 1 CUP, UNIT-DOSE (62135-841-45)", "package_ndc": "62135-841-24", "marketing_start_date": "20240327"}, {"sample": false, "description": "250 mL in 1 BOTTLE (62135-841-54)", "package_ndc": "62135-841-54", "marketing_start_date": "20240327"}], "brand_name": "Oxcarbazepine", "product_id": "62135-841_47e4dcae-6305-e681-e063-6294a90a5359", "dosage_form": "SUSPENSION", "pharm_class": ["Anti-epileptic Agent [EPC]", "Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "62135-841", "generic_name": "Oxcarbazepine", "labeler_name": "Chartwell 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": "20271231"}