carbamazepine

Generic: carbamazepine

Labeler: ani pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name carbamazepine
Generic Name carbamazepine
Labeler ani pharmaceuticals, inc.
Dosage Form SUSPENSION
Routes
ORAL
Active Ingredients

carbamazepine 100 mg/5mL

Manufacturer
ANI Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 70954-240
Product ID 70954-240_cd071fae-afb9-4b46-8e1c-dcb99d5c0f61
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA214277
Listing Expiration 2027-12-31
Marketing Start 2022-10-06

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 70954240
Hyphenated Format 70954-240

Supplemental Identifiers

RxCUI
308976
UPC
0370954240105
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 ANDA214277 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/5mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (70954-240-10) / 450 mL in 1 BOTTLE
source: ndc

Packages (1)

70954-240-10 1 BOTTLE in 1 CARTON (70954-240-10) / 450 mL in 1 BOTTLE

Ingredients (1)

carbamazepine (100 mg/5mL)

Linked Drug Pages (1)

Carbamazepine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "cd071fae-afb9-4b46-8e1c-dcb99d5c0f61", "openfda": {"nui": ["N0000008486", "N0000175751", "N0000185506", "N0000191266", "N0000187064", "N0000185507", "N0000185607"], "upc": ["0370954240105"], "unii": ["33CM23913M"], "rxcui": ["308976"], "spl_set_id": ["e006049f-1c0c-4544-969e-0344d1b8c5ba"], "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": ["ANI Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (70954-240-10)  / 450 mL in 1 BOTTLE", "package_ndc": "70954-240-10", "marketing_start_date": "20221006"}], "brand_name": "Carbamazepine", "product_id": "70954-240_cd071fae-afb9-4b46-8e1c-dcb99d5c0f61", "dosage_form": "SUSPENSION", "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": "70954-240", "generic_name": "Carbamazepine", "labeler_name": "ANI Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Carbamazepine", "active_ingredients": [{"name": "CARBAMAZEPINE", "strength": "100 mg/5mL"}], "application_number": "ANDA214277", "marketing_category": "ANDA", "marketing_start_date": "20221006", "listing_expiration_date": "20271231"}