oxcarbazepine

Generic: oxcarbazepine

Labeler: ajanta pharma usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name oxcarbazepine
Generic Name oxcarbazepine
Labeler ajanta pharma usa inc.
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

oxcarbazepine 300 mg/1

Manufacturer
Ajanta Pharma USA Inc.

Identifiers & Regulatory

Product NDC 27241-238
Product ID 27241-238_ffbd0c62-0cbd-4ea3-b1a1-1a40a16884e3
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA217659
Listing Expiration 2027-12-31
Marketing Start 2024-02-22

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 27241238
Hyphenated Format 27241-238

Supplemental Identifiers

RxCUI
1365653 1365842 1365844
UPC
0327241238017 0327241239014 0327241237010
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 ANDA217659 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 300 mg/1
source: ndc
Packaging
  • 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (27241-238-01)
source: ndc

Packages (1)

27241-238-01 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (27241-238-01)

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": "ffbd0c62-0cbd-4ea3-b1a1-1a40a16884e3", "openfda": {"nui": ["N0000175753", "N0000008486"], "upc": ["0327241238017", "0327241239014", "0327241237010"], "unii": ["VZI5B1W380"], "rxcui": ["1365653", "1365842", "1365844"], "spl_set_id": ["d947e9b1-2a15-4048-bb4e-fe56b6851848"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "pharm_class_epc": ["Anti-epileptic Agent [EPC]"], "manufacturer_name": ["Ajanta Pharma USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE (27241-238-01)", "package_ndc": "27241-238-01", "marketing_start_date": "20240222"}], "brand_name": "Oxcarbazepine", "product_id": "27241-238_ffbd0c62-0cbd-4ea3-b1a1-1a40a16884e3", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Anti-epileptic Agent [EPC]", "Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "27241-238", "generic_name": "Oxcarbazepine", "labeler_name": "Ajanta Pharma USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Oxcarbazepine", "active_ingredients": [{"name": "OXCARBAZEPINE", "strength": "300 mg/1"}], "application_number": "ANDA217659", "marketing_category": "ANDA", "marketing_start_date": "20240222", "listing_expiration_date": "20271231"}