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OXTELLAR XR

Oxcarbazepine · Tablet

Prescription NDA TE AB RLD
Informational index, not medical advice. Content is reproduced from public FDA and NLM data. Always confirm against the manufacturer's current prescribing information. Report adverse events to FDA MedWatch.

Overview

Brand name
OXTELLAR XR
Generic name
Oxcarbazepine
Dosage form
Tablet
Route
Oral
Marketing category
NDA · NDA
Labeler
Supernus Pharmaceuticals, Inc.
Product type
Human Prescription Drug
DEA schedule
Not scheduled
Active ingredients
3
NDC product codes
3
Packages
9
Data completeness
54% of corroborating sources present

Active ingredients

Source: NDC Directory
Active ingredients and strengths as listed in the NDC Directory.
Ingredient Strength RxCUI Monograph
Oxcarbazepine 150 mg/1 312136 View
Oxcarbazepine 300 mg/1 312136 View
Oxcarbazepine 600 mg/1 312136 View

Forms, strengths and routes

Source: NDC Directory
Dosage form
Tablet
Route of administration
Oral
Presentations
12

Pharmacologic classes are listed in the class section below.

Pharmacologic class

Source: NDC Directory
Established pharmacologic classes (EPC), mechanisms of action (MoA), chemical structures (CS) and physiologic effects (PE).
Class Type Browse
Anti-epileptic Agent [EPC] EPC All 62 members
Decreased Central Nervous System Disorganized Electrical Activity [PE] PE All 114 members

Regulatory status

Source: Drugs@FDANDC Directory
Application number
202810
Application type
NDA · New Drug Application
Approval date
October 19, 2012
Sponsor
SUPERNUS PHARMS
Products on application
3
Submissions recorded
10
Products approved under application 202810.
Product Trade name Form Strength Ingredient Status TE Flags
202810-001 OXTELLAR XR TABLET, EXTENDED RELEASE OXCARBAZEPINE Prescription AB RLD
202810-002 OXTELLAR XR TABLET, EXTENDED RELEASE OXCARBAZEPINE Prescription AB RLD
202810-003 OXTELLAR XR TABLET, EXTENDED RELEASE OXCARBAZEPINE Prescription AB RLD RS

Therapeutic equivalence

Source: Orange Book
TE code
AB
Reference Listed Drug
Yes
Reference Standard
Yes

What this rating means: Therapeutically equivalent — bioequivalence demonstrated by in vivo or in vitro testing

Codes beginning with “A” indicate products the FDA considers therapeutically equivalent. Codes beginning with “B” indicate bioequivalence has not been established. See methodology.

Patents and exclusivity

Source: Orange Book
Patent listings submitted under 21 U.S.C. 355(b)(1) and (c)(2).
Patent Expires Product Substance Use code Submitted
10220042 April 13, 2027 001 No U-2501 March 28, 2019
7910131 April 13, 2027 001 No U-2041 November 20, 2012
9119791 April 13, 2027 001 No U-2041 September 11, 2015
11896599 April 13, 2027 001 No February 28, 2024
9855278 April 13, 2027 001 No January 5, 2018
7722898 April 13, 2027 001 No November 20, 2012
8821930 April 13, 2027 001 No —
8617600 April 13, 2027 001 No —
11166960 April 13, 2027 001 No November 24, 2021
9370525 April 13, 2027 001 No June 24, 2016
9351975 April 13, 2027 001 No June 10, 2016
10220042 April 13, 2027 002 No U-2501 March 28, 2019
9119791 April 13, 2027 002 No U-2041 September 11, 2015
7910131 April 13, 2027 002 No U-2041 —
11166960 April 13, 2027 002 No November 24, 2021
9855278 April 13, 2027 002 No January 5, 2018
7722898 April 13, 2027 002 No —
9370525 April 13, 2027 002 No June 24, 2016
8821930 April 13, 2027 002 No —
8617600 April 13, 2027 002 No —
11896599 April 13, 2027 002 No February 28, 2024
9351975 April 13, 2027 002 No June 10, 2016
7910131 April 13, 2027 003 No U-2041 —
9119791 April 13, 2027 003 No U-2041 September 11, 2015
10220042 April 13, 2027 003 No U-2501 March 28, 2019
9370525 April 13, 2027 003 No June 24, 2016
9855278 April 13, 2027 003 No January 5, 2018
11166960 April 13, 2027 003 No November 24, 2021
7722898 April 13, 2027 003 No —
8821930 April 13, 2027 003 No —
9351975 April 13, 2027 003 No June 10, 2016
8617600 April 13, 2027 003 No —
11896599 April 13, 2027 003 No February 28, 2024

Approval history

Source: Drugs@FDA
Most recent submissions on application 202810.
Type No. Action Status Date Review
Supplement 20 Labeling Approved August 14, 2024 Standard
Supplement 14 Labeling Approved August 8, 2023 Standard
Supplement 10 Efficacy Approved December 13, 2018 Standard
Supplement 7 Manufacturing (CMC) Approved June 17, 2016 Standard
Supplement 6 Manufacturing (CMC) Approved December 23, 2015 Standard
Supplement 5 Labeling Approved December 4, 2015 Standard
Supplement 4 Manufacturing (CMC) Approved September 11, 2015 Standard
Supplement 2 Manufacturing (CMC) Approved August 23, 2013 Standard
Supplement 1 Manufacturing (CMC) Approved June 14, 2013 Standard
Original application 1 Type 3 - New Dosage Form Approved October 19, 2012 Standard

Review documents

  • 0 · Supplement · August 16, 2024
  • 0 · Supplement · August 16, 2024
  • 0 · Supplement · August 16, 2024
  • 0 · Supplement · August 25, 2023
  • 0 · Supplement · August 9, 2023
  • 0 · Supplement · January 9, 2019
  • 0 · Supplement · December 20, 2018
  • 0 · Supplement · December 8, 2015
  • 0 · Supplement · December 8, 2015
  • 0 · Original application · November 29, 2012
  • 0 · Original application · November 29, 2012
  • 0 · Original application · October 23, 2012
  • 0 · Original application · October 22, 2012
  • 0 · Original application · January 1, 1900
  • 0 · Original application · January 1, 1900
  • 0 · Original application · January 1, 1900

Adverse event reports

Source: openFDA FAERS
31,341
FAERS reports mentioning this drug
as of 2026-09-25T03:42:24+00:00
A report count is not a risk measure. FAERS accepts voluntary and mandatory reports without establishing causation, and reporting is influenced by how widely a drug is used, how long it has been marketed, and media attention. FDA states that reports “do not prove that the drug caused the event”. Compare rates, not totals.

Attributed to this product's most-reported active ingredient: OXCARBAZEPINE. Combination products with more than six active ingredients are not attributed, because a report count summed across a long ingredient list measures the list, not the medicine.

Packaging and NDCs

Source: NDC Directory
Every National Drug Code package associated with this medication. The NDC is the identifier used for dispensing, billing and pharmacovigilance in the United States.
Package NDC Product NDC Labeler Description Marketing start
17772-121-01 17772-121 Supernus Pharmaceuticals, Inc. 100 TABLET in 1 BOTTLE (17772-121-01) January 17, 2013
17772-121-07 17772-121 Supernus Pharmaceuticals, Inc. 7 TABLET in 1 BOTTLE (17772-121-07) July 1, 2023
17772-121-10 17772-121 Supernus Pharmaceuticals, Inc. 5 TABLET in 1 BLISTER PACK (17772-121-10) January 17, 2013
17772-122-01 17772-122 Supernus Pharmaceuticals, Inc. 100 TABLET in 1 BOTTLE (17772-122-01) January 17, 2013
17772-122-07 17772-122 Supernus Pharmaceuticals, Inc. 7 TABLET in 1 BOTTLE (17772-122-07) July 1, 2023
17772-122-10 17772-122 Supernus Pharmaceuticals, Inc. 5 TABLET in 1 BLISTER PACK (17772-122-10) January 17, 2013
17772-123-01 17772-123 Supernus Pharmaceuticals, Inc. 100 TABLET in 1 BOTTLE (17772-123-01) January 17, 2013
17772-123-07 17772-123 Supernus Pharmaceuticals, Inc. 7 TABLET in 1 BOTTLE (17772-123-07) July 1, 2023
17772-123-10 17772-123 Supernus Pharmaceuticals, Inc. 5 TABLET in 1 BLISTER PACK (17772-123-10) January 17, 2013
17772-121 17772-121 Supernus Pharmaceuticals, Inc. — January 17, 2013
17772-122 17772-122 Supernus Pharmaceuticals, Inc. — January 17, 2013
17772-123 17772-123 Supernus Pharmaceuticals, Inc. — January 17, 2013

Sources for this page

Every dataset that contributed a fact to this page.
Dataset Agency Used for
NDC Directory FDA Identity, ingredients, strengths, forms, routes, labelers, packages
Drugs@FDA FDA Application, sponsor, submissions, review documents, marketing status
Orange Book FDA Therapeutic equivalence codes, reference drug flags, patents, exclusivity
FAERS FDA Adverse event report counts

Generated September 25, 2026 · 11 sections on this page.