carbamazepine

Generic: carbamazepine

Labeler: zydus pharmaceuticals (usa) inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name carbamazepine
Generic Name carbamazepine
Labeler zydus pharmaceuticals (usa) inc.
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

carbamazepine 200 mg/1

Manufacturer
Zydus Pharmaceuticals (USA) Inc.

Identifiers & Regulatory

Product NDC 68382-556
Product ID 68382-556_1d3f1616-667b-4e79-aa22-35bf35c4c108
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA205571
Listing Expiration 2026-12-31
Marketing Start 2019-03-12

Pharmacologic Class

Established (EPC)
mood stabilizer [epc]
Mechanism of Action
cytochrome p450 3a4 inducers [moa] cytochrome p450 1a2 inducers [moa] cytochrome p450 2b6 inducers [moa] cytochrome p450 2c9 inducers [moa] cytochrome p450 2c19 inducers [moa]
Physiologic Effect
decreased central nervous system disorganized electrical activity [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68382556
Hyphenated Format 68382-556

Supplemental Identifiers

RxCUI
199378 402505 402506
UNII
33CM23913M
NUI
N0000008486 N0000175751 N0000185506 N0000191266 N0000187064 N0000185507 N0000185607

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 carbamazepine (source: ndc)
Generic Name carbamazepine (source: ndc)
Application Number ANDA205571 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/1
source: ndc
Packaging
  • 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-556-01)
  • 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-556-06)
  • 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-556-16)
  • 10 BLISTER PACK in 1 CARTON (68382-556-30) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
source: ndc

Packages (4)

68382-556-01 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-556-01) 68382-556-06 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-556-06) 68382-556-16 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-556-16) 68382-556-30 10 BLISTER PACK in 1 CARTON (68382-556-30) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK

Ingredients (1)

carbamazepine (200 mg/1)

Linked Drug Pages (1)

carbamazepine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "1d3f1616-667b-4e79-aa22-35bf35c4c108", "openfda": {"nui": ["N0000008486", "N0000175751", "N0000185506", "N0000191266", "N0000187064", "N0000185507", "N0000185607"], "unii": ["33CM23913M"], "rxcui": ["199378", "402505", "402506"], "spl_set_id": ["c5e4a25a-0137-4327-96f5-15735891ad5c"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "pharm_class_epc": ["Mood Stabilizer [EPC]"], "pharm_class_moa": ["Cytochrome P450 3A4 Inducers [MoA]", "Cytochrome P450 1A2 Inducers [MoA]", "Cytochrome P450 2B6 Inducers [MoA]", "Cytochrome P450 2C9 Inducers [MoA]", "Cytochrome P450 2C19 Inducers [MoA]"], "manufacturer_name": ["Zydus Pharmaceuticals (USA) Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-556-01)", "package_ndc": "68382-556-01", "marketing_start_date": "20190312"}, {"sample": false, "description": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-556-06)", "package_ndc": "68382-556-06", "marketing_start_date": "20190312"}, {"sample": false, "description": "90 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-556-16)", "package_ndc": "68382-556-16", "marketing_start_date": "20190312"}, {"sample": false, "description": "10 BLISTER PACK in 1 CARTON (68382-556-30)  / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK", "package_ndc": "68382-556-30", "marketing_start_date": "20190312"}], "brand_name": "carbamazepine", "product_id": "68382-556_1d3f1616-667b-4e79-aa22-35bf35c4c108", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Cytochrome P450 1A2 Inducers [MoA]", "Cytochrome P450 2B6 Inducers [MoA]", "Cytochrome P450 2C19 Inducers [MoA]", "Cytochrome P450 2C9 Inducers [MoA]", "Cytochrome P450 3A4 Inducers [MoA]", "Decreased Central Nervous System Disorganized Electrical Activity [PE]", "Mood Stabilizer [EPC]"], "product_ndc": "68382-556", "generic_name": "carbamazepine", "labeler_name": "Zydus Pharmaceuticals (USA) Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "carbamazepine", "active_ingredients": [{"name": "CARBAMAZEPINE", "strength": "200 mg/1"}], "application_number": "ANDA205571", "marketing_category": "ANDA", "marketing_start_date": "20190312", "listing_expiration_date": "20261231"}