oxtellar xr

Generic: oxcarbazepine

Labeler: supernus pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name oxtellar xr
Generic Name oxcarbazepine
Labeler supernus pharmaceuticals, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

oxcarbazepine 300 mg/1

Manufacturer
Supernus Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 17772-122
Product ID 17772-122_41c1a4d4-ff5a-00b4-e063-6294a90a6ec7
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA202810
Listing Expiration 2026-12-31
Marketing Start 2013-01-17

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 17772122
Hyphenated Format 17772-122

Supplemental Identifiers

RxCUI
1365653 1365660 1365842 1365844 1365847 1365850
UPC
0317772123012 0317772121018 0317772122015
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 oxtellar xr (source: ndc)
Generic Name oxcarbazepine (source: ndc)
Application Number NDA202810 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 300 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (17772-122-01)
  • 7 TABLET in 1 BOTTLE (17772-122-07)
  • 5 TABLET in 1 BLISTER PACK (17772-122-10)
source: ndc

Packages (3)

17772-122-01 100 TABLET in 1 BOTTLE (17772-122-01) 17772-122-07 7 TABLET in 1 BOTTLE (17772-122-07) 17772-122-10 5 TABLET in 1 BLISTER PACK (17772-122-10)

Ingredients (1)

oxcarbazepine (300 mg/1)

Linked Drug Pages (1)

OXTELLAR XR ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "41c1a4d4-ff5a-00b4-e063-6294a90a6ec7", "openfda": {"nui": ["N0000175753", "N0000008486"], "upc": ["0317772123012", "0317772121018", "0317772122015"], "unii": ["VZI5B1W380"], "rxcui": ["1365653", "1365660", "1365842", "1365844", "1365847", "1365850"], "spl_set_id": ["aa610e56-1d1d-11e1-8bc2-0800200c9a66"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "pharm_class_epc": ["Anti-epileptic Agent [EPC]"], "manufacturer_name": ["Supernus Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (17772-122-01)", "package_ndc": "17772-122-01", "marketing_start_date": "20130117"}, {"sample": true, "description": "7 TABLET in 1 BOTTLE (17772-122-07)", "package_ndc": "17772-122-07", "marketing_start_date": "20230701"}, {"sample": true, "description": "5 TABLET in 1 BLISTER PACK (17772-122-10)", "package_ndc": "17772-122-10", "marketing_start_date": "20130117"}], "brand_name": "OXTELLAR XR", "product_id": "17772-122_41c1a4d4-ff5a-00b4-e063-6294a90a6ec7", "dosage_form": "TABLET", "pharm_class": ["Anti-epileptic Agent [EPC]", "Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "17772-122", "generic_name": "OXCARBAZEPINE", "labeler_name": "Supernus Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "OXTELLAR XR", "active_ingredients": [{"name": "OXCARBAZEPINE", "strength": "300 mg/1"}], "application_number": "NDA202810", "marketing_category": "NDA", "marketing_start_date": "20130117", "listing_expiration_date": "20261231"}