carbamazepine

Generic: carbamazepine

Labeler: pd-rx pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name carbamazepine
Generic Name carbamazepine
Labeler pd-rx pharmaceuticals, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

carbamazepine 200 mg/1

Manufacturer
PD-Rx Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 43063-328
Product ID 43063-328_47a67b68-3732-3c2d-e063-6394a90a7788
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA074649
Listing Expiration 2027-12-31
Marketing Start 1996-10-03

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 43063328
Hyphenated Format 43063-328

Supplemental Identifiers

RxCUI
308979
UPC
0343063328309
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 ANDA074649 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/1
source: ndc
Packaging
  • 12 TABLET in 1 BOTTLE, PLASTIC (43063-328-12)
  • 30 TABLET in 1 BOTTLE, PLASTIC (43063-328-30)
source: ndc

Packages (2)

43063-328-12 12 TABLET in 1 BOTTLE, PLASTIC (43063-328-12) 43063-328-30 30 TABLET in 1 BOTTLE, PLASTIC (43063-328-30)

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": "47a67b68-3732-3c2d-e063-6394a90a7788", "openfda": {"nui": ["N0000008486", "N0000175751", "N0000185506", "N0000191266", "N0000187064", "N0000185507", "N0000185607"], "upc": ["0343063328309"], "unii": ["33CM23913M"], "rxcui": ["308979"], "spl_set_id": ["ce5aec7a-e161-46bf-8fc0-afb41689e59a"], "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": ["PD-Rx Pharmaceuticals, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "12 TABLET in 1 BOTTLE, PLASTIC (43063-328-12)", "package_ndc": "43063-328-12", "marketing_start_date": "20110921"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE, PLASTIC (43063-328-30)", "package_ndc": "43063-328-30", "marketing_start_date": "20110921"}], "brand_name": "Carbamazepine", "product_id": "43063-328_47a67b68-3732-3c2d-e063-6394a90a7788", "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": "43063-328", "generic_name": "Carbamazepine", "labeler_name": "PD-Rx Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Carbamazepine", "active_ingredients": [{"name": "CARBAMAZEPINE", "strength": "200 mg/1"}], "application_number": "ANDA074649", "marketing_category": "ANDA", "marketing_start_date": "19961003", "listing_expiration_date": "20271231"}