carbamazepine

Generic: carbamazepine

Labeler: atlantic biologicals corps
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name carbamazepine
Generic Name carbamazepine
Labeler atlantic biologicals corps
Dosage Form SUSPENSION
Routes
ORAL
Active Ingredients

carbamazepine 100 mg/5mL

Manufacturer
Atlantic Biologicals Corps

Identifiers & Regulatory

Product NDC 17856-4047
Product ID 17856-4047_30a4fdec-3fbc-034c-e063-6294a90aa786
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076729
Listing Expiration 2026-12-31
Marketing Start 2004-09-20

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 178564047
Hyphenated Format 17856-4047

Supplemental Identifiers

RxCUI
308976
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 ANDA076729 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/5mL
source: ndc
Packaging
  • 10 mL in 1 CUP (17856-4047-1)
source: ndc

Packages (1)

17856-4047-1 10 mL in 1 CUP (17856-4047-1)

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": "30a4fdec-3fbc-034c-e063-6294a90aa786", "openfda": {"nui": ["N0000008486", "N0000175751", "N0000185506", "N0000191266", "N0000187064", "N0000185507", "N0000185607"], "unii": ["33CM23913M"], "rxcui": ["308976"], "spl_set_id": ["25939406-a836-43cd-9301-56808e9b31ec"], "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": ["Atlantic Biologicals Corps"]}, "finished": true, "packaging": [{"sample": false, "description": "10 mL in 1 CUP (17856-4047-1)", "package_ndc": "17856-4047-1", "marketing_start_date": "20150428"}], "brand_name": "Carbamazepine", "product_id": "17856-4047_30a4fdec-3fbc-034c-e063-6294a90aa786", "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": "17856-4047", "generic_name": "Carbamazepine", "labeler_name": "Atlantic Biologicals Corps", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Carbamazepine", "active_ingredients": [{"name": "CARBAMAZEPINE", "strength": "100 mg/5mL"}], "application_number": "ANDA076729", "marketing_category": "ANDA", "marketing_start_date": "20040920", "listing_expiration_date": "20261231"}