carbamazepine

Generic: carbamazepine

Labeler: chartwell governmental & specialty rx, llc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name carbamazepine
Generic Name carbamazepine
Labeler chartwell governmental & specialty rx, llc.
Dosage Form SUSPENSION
Routes
ORAL
Active Ingredients

carbamazepine 100 mg/5mL

Manufacturer
Chartwell Governmental & Specialty RX, LLC.

Identifiers & Regulatory

Product NDC 68999-802
Product ID 68999-802_41dd08a0-b89b-6ad3-e063-6394a90afdc6
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA075714
Listing Expiration 2026-12-31
Marketing Start 2002-06-05

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 68999802
Hyphenated Format 68999-802

Supplemental Identifiers

RxCUI
308976
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 ANDA075714 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/5mL
source: ndc
Packaging
  • 2 TRAY in 1 BOX (68999-802-24) / 10 CUP in 1 TRAY / 5 mL in 1 CUP (68999-802-45)
source: ndc

Packages (1)

68999-802-24 2 TRAY in 1 BOX (68999-802-24) / 10 CUP in 1 TRAY / 5 mL in 1 CUP (68999-802-45)

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": "41dd08a0-b89b-6ad3-e063-6394a90afdc6", "openfda": {"nui": ["N0000008486", "N0000175751", "N0000185506", "N0000191266", "N0000187064", "N0000185507", "N0000185607"], "unii": ["33CM23913M"], "rxcui": ["308976"], "spl_set_id": ["35298eaf-3478-4dfb-a629-298dd52713f0"], "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": ["Chartwell Governmental & Specialty RX, LLC."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2 TRAY in 1 BOX (68999-802-24)  / 10 CUP in 1 TRAY / 5 mL in 1 CUP (68999-802-45)", "package_ndc": "68999-802-24", "marketing_start_date": "20251015"}], "brand_name": "Carbamazepine", "product_id": "68999-802_41dd08a0-b89b-6ad3-e063-6394a90afdc6", "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": "68999-802", "generic_name": "Carbamazepine", "labeler_name": "Chartwell Governmental & Specialty RX, LLC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Carbamazepine", "active_ingredients": [{"name": "CARBAMAZEPINE", "strength": "100 mg/5mL"}], "application_number": "ANDA075714", "marketing_category": "ANDA", "marketing_start_date": "20020605", "listing_expiration_date": "20261231"}