carbamazepine

Generic: carbamazepine

Labeler: american health packaging
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name carbamazepine
Generic Name carbamazepine
Labeler american health packaging
Dosage Form TABLET
Routes
ORAL
Active Ingredients

carbamazepine 200 mg/1

Manufacturer
American Health Packaging

Identifiers & Regulatory

Product NDC 68084-444
Product ID 68084-444_2515a881-5a14-86cf-e063-6394a90a5c47
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA075948
Listing Expiration 2026-12-31
Marketing Start 2023-06-02

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 68084444
Hyphenated Format 68084-444

Supplemental Identifiers

RxCUI
308979
UNII
33CM23913M
NUI
N0000008486 N0000175751 N0000185506 N0000191266 N0000187064 N0000185507 N0000185607

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 ANDA075948 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/1
source: ndc
Packaging
  • 100 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-444-01) / 1 TABLET in 1 BLISTER PACK (68084-444-11)
source: ndc

Packages (1)

68084-444-01 100 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-444-01) / 1 TABLET in 1 BLISTER PACK (68084-444-11)

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": "2515a881-5a14-86cf-e063-6394a90a5c47", "openfda": {"nui": ["N0000008486", "N0000175751", "N0000185506", "N0000191266", "N0000187064", "N0000185507", "N0000185607"], "unii": ["33CM23913M"], "rxcui": ["308979"], "spl_set_id": ["1dd3d934-efee-4fdb-ae6f-f47b61831a2e"], "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": ["American Health Packaging"]}, "finished": true, "packaging": [{"sample": false, "description": "100 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-444-01)  / 1 TABLET in 1 BLISTER PACK (68084-444-11)", "package_ndc": "68084-444-01", "marketing_start_date": "20230602"}], "brand_name": "Carbamazepine", "product_id": "68084-444_2515a881-5a14-86cf-e063-6394a90a5c47", "dosage_form": "TABLET", "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": "68084-444", "generic_name": "Carbamazepine", "labeler_name": "American Health Packaging", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Carbamazepine", "active_ingredients": [{"name": "CARBAMAZEPINE", "strength": "200 mg/1"}], "application_number": "ANDA075948", "marketing_category": "ANDA", "marketing_start_date": "20230602", "listing_expiration_date": "20261231"}