carbamazepine

Generic: carbamazepine

Labeler: chartwell rx, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

carbamazepine 100 mg/5mL

Manufacturer
Chartwell RX, LLC

Identifiers & Regulatory

Product NDC 62135-802
Product ID 62135-802_199bb366-8124-4f1f-e063-6294a90a231b
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 62135802
Hyphenated Format 62135-802

Supplemental Identifiers

RxCUI
308976
UPC
0362135802530
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 (62135-802-24) / 10 PACKAGE in 1 TRAY / 5 mL in 1 PACKAGE (62135-802-45)
  • 450 mL in 1 BOTTLE (62135-802-53)
source: ndc

Packages (2)

62135-802-24 2 TRAY in 1 BOX (62135-802-24) / 10 PACKAGE in 1 TRAY / 5 mL in 1 PACKAGE (62135-802-45) 62135-802-53 450 mL in 1 BOTTLE (62135-802-53)

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": "199bb366-8124-4f1f-e063-6294a90a231b", "openfda": {"nui": ["N0000008486", "N0000175751", "N0000185506", "N0000191266", "N0000187064", "N0000185507", "N0000185607"], "upc": ["0362135802530"], "unii": ["33CM23913M"], "rxcui": ["308976"], "spl_set_id": ["8d5ace90-983b-48c4-baf1-b44f6af146de"], "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 RX, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2 TRAY in 1 BOX (62135-802-24)  / 10 PACKAGE in 1 TRAY / 5 mL in 1 PACKAGE (62135-802-45)", "package_ndc": "62135-802-24", "marketing_start_date": "20240528"}, {"sample": false, "description": "450 mL in 1 BOTTLE (62135-802-53)", "package_ndc": "62135-802-53", "marketing_start_date": "20231201"}], "brand_name": "Carbamazepine", "product_id": "62135-802_199bb366-8124-4f1f-e063-6294a90a231b", "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": "62135-802", "generic_name": "Carbamazepine", "labeler_name": "Chartwell 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"}