carbamazepine er

Generic: carbamazepine er

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

Drug Facts

Product Profile

Brand Name carbamazepine er
Generic Name carbamazepine er
Labeler chartwell rx, llc
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

carbamazepine 200 mg/1

Manufacturer
Chartwell RX, LLC

Identifiers & Regulatory

Product NDC 62135-928
Product ID 62135-928_458c15a3-d257-681b-e063-6294a90a282a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA215591
Listing Expiration 2026-12-31
Marketing Start 2022-03-31

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 62135928
Hyphenated Format 62135-928

Supplemental Identifiers

RxCUI
199378 402505 402506
UPC
0362135930608 0362135928605 0362135927608
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 er (source: ndc)
Generic Name carbamazepine er (source: ndc)
Application Number ANDA215591 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/1
source: ndc
Packaging
  • 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (62135-928-60)
source: ndc

Packages (1)

62135-928-60 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (62135-928-60)

Ingredients (1)

carbamazepine (200 mg/1)

Linked Drug Pages (1)

Carbamazepine ER ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "458c15a3-d257-681b-e063-6294a90a282a", "openfda": {"nui": ["N0000008486", "N0000175751", "N0000185506", "N0000191266", "N0000187064", "N0000185507", "N0000185607"], "upc": ["0362135930608", "0362135928605", "0362135927608"], "unii": ["33CM23913M"], "rxcui": ["199378", "402505", "402506"], "spl_set_id": ["bf2bff52-d1ae-4b81-951c-7d39d3c5058f"], "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": "60 TABLET, EXTENDED RELEASE in 1 BOTTLE (62135-928-60)", "package_ndc": "62135-928-60", "marketing_start_date": "20241106"}], "brand_name": "Carbamazepine ER", "product_id": "62135-928_458c15a3-d257-681b-e063-6294a90a282a", "dosage_form": "TABLET, EXTENDED RELEASE", "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": "62135-928", "generic_name": "Carbamazepine ER", "labeler_name": "Chartwell RX, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Carbamazepine ER", "active_ingredients": [{"name": "CARBAMAZEPINE", "strength": "200 mg/1"}], "application_number": "ANDA215591", "marketing_category": "ANDA", "marketing_start_date": "20220331", "listing_expiration_date": "20261231"}