carbamazepine

Generic: carbamazepine

Labeler: sun pharmaceutical industries, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name carbamazepine
Generic Name carbamazepine
Labeler sun pharmaceutical industries, inc.
Dosage Form TABLET, CHEWABLE
Routes
ORAL
Active Ingredients

carbamazepine 100 mg/1

Manufacturer
Sun Pharmaceutical Industries, Inc.

Identifiers & Regulatory

Product NDC 51672-4041
Product ID 51672-4041_48fd19fc-5d5b-0d24-e063-6294a90a0aa0
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA075687
Listing Expiration 2027-12-31
Marketing Start 2000-10-24

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 516724041
Hyphenated Format 51672-4041

Supplemental Identifiers

RxCUI
197442 199378 308973 308976 308979 402505 402506
UPC
0351672405014 0351672412418 0351672404741
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 ANDA075687 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 10 BLISTER PACK in 1 CARTON (51672-4041-0) / 10 TABLET, CHEWABLE in 1 BLISTER PACK
  • 100 TABLET, CHEWABLE in 1 BOTTLE (51672-4041-1)
  • 500 TABLET, CHEWABLE in 1 BOTTLE (51672-4041-2)
  • 5 BLISTER PACK in 1 CARTON (51672-4041-9) / 10 TABLET, CHEWABLE in 1 BLISTER PACK
source: ndc

Packages (4)

51672-4041-0 10 BLISTER PACK in 1 CARTON (51672-4041-0) / 10 TABLET, CHEWABLE in 1 BLISTER PACK 51672-4041-1 100 TABLET, CHEWABLE in 1 BOTTLE (51672-4041-1) 51672-4041-2 500 TABLET, CHEWABLE in 1 BOTTLE (51672-4041-2) 51672-4041-9 5 BLISTER PACK in 1 CARTON (51672-4041-9) / 10 TABLET, CHEWABLE in 1 BLISTER PACK

Ingredients (1)

carbamazepine (100 mg/1)

Linked Drug Pages (1)

Carbamazepine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "48fd19fc-5d5b-0d24-e063-6294a90a0aa0", "openfda": {"nui": ["N0000008486", "N0000175751", "N0000185506", "N0000191266", "N0000187064", "N0000185507", "N0000185607"], "upc": ["0351672405014", "0351672412418", "0351672404741"], "unii": ["33CM23913M"], "rxcui": ["197442", "199378", "308973", "308976", "308979", "402505", "402506"], "spl_set_id": ["0526a054-3eda-49b4-b390-7d5d16e30af8"], "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": ["Sun Pharmaceutical Industries, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 BLISTER PACK in 1 CARTON (51672-4041-0)  / 10 TABLET, CHEWABLE in 1 BLISTER PACK", "package_ndc": "51672-4041-0", "marketing_start_date": "20001024"}, {"sample": false, "description": "100 TABLET, CHEWABLE in 1 BOTTLE (51672-4041-1)", "package_ndc": "51672-4041-1", "marketing_start_date": "20001024"}, {"sample": false, "description": "500 TABLET, CHEWABLE in 1 BOTTLE (51672-4041-2)", "package_ndc": "51672-4041-2", "marketing_start_date": "20001024"}, {"sample": false, "description": "5 BLISTER PACK in 1 CARTON (51672-4041-9)  / 10 TABLET, CHEWABLE in 1 BLISTER PACK", "package_ndc": "51672-4041-9", "marketing_start_date": "20001024"}], "brand_name": "Carbamazepine", "product_id": "51672-4041_48fd19fc-5d5b-0d24-e063-6294a90a0aa0", "dosage_form": "TABLET, CHEWABLE", "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": "51672-4041", "generic_name": "Carbamazepine", "labeler_name": "Sun Pharmaceutical Industries, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Carbamazepine", "active_ingredients": [{"name": "CARBAMAZEPINE", "strength": "100 mg/1"}], "application_number": "ANDA075687", "marketing_category": "ANDA", "marketing_start_date": "20001024", "listing_expiration_date": "20271231"}