imatinib

Generic: imatinib

Labeler: dr.reddy's laboratories inc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name imatinib
Generic Name imatinib
Labeler dr.reddy's laboratories inc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

imatinib mesylate 400 mg/1

Manufacturer
Dr.Reddy's Laboratories Inc

Identifiers & Regulatory

Product NDC 43598-345
Product ID 43598-345_38a9944b-db90-72f2-3f0b-7767da490ae2
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA206547
Listing Expiration 2026-12-31
Marketing Start 2018-08-13

Pharmacologic Class

Classes
bcr-abl tyrosine kinase inhibitors [moa] cytochrome p450 2d6 inhibitors [moa] cytochrome p450 3a4 inhibitors [moa] kinase inhibitor [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 43598345
Hyphenated Format 43598-345

Supplemental Identifiers

RxCUI
403878 403879
UNII
8A1O1M485B

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 imatinib (source: ndc)
Generic Name imatinib (source: ndc)
Application Number ANDA206547 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 400 mg/1
source: ndc
Packaging
  • 500 TABLET in 1 CONTAINER (43598-345-05)
  • 30 TABLET in 1 CONTAINER (43598-345-30)
  • 3 BLISTER PACK in 1 CARTON (43598-345-31) / 10 TABLET in 1 BLISTER PACK
  • 90 TABLET in 1 CONTAINER (43598-345-90)
source: ndc

Packages (4)

43598-345-05 500 TABLET in 1 CONTAINER (43598-345-05) 43598-345-30 30 TABLET in 1 CONTAINER (43598-345-30) 43598-345-31 3 BLISTER PACK in 1 CARTON (43598-345-31) / 10 TABLET in 1 BLISTER PACK 43598-345-90 90 TABLET in 1 CONTAINER (43598-345-90)

Ingredients (1)

imatinib mesylate (400 mg/1)

Linked Drug Pages (1)

Imatinib ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "38a9944b-db90-72f2-3f0b-7767da490ae2", "openfda": {"unii": ["8A1O1M485B"], "rxcui": ["403878", "403879"], "spl_set_id": ["559dd8e5-11f9-70cd-3fb0-9f9eb8484a37"], "manufacturer_name": ["Dr.Reddy's Laboratories Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 TABLET in 1 CONTAINER (43598-345-05)", "package_ndc": "43598-345-05", "marketing_start_date": "20180813"}, {"sample": false, "description": "30 TABLET in 1 CONTAINER (43598-345-30)", "package_ndc": "43598-345-30", "marketing_start_date": "20180813"}, {"sample": false, "description": "3 BLISTER PACK in 1 CARTON (43598-345-31)  / 10 TABLET in 1 BLISTER PACK", "package_ndc": "43598-345-31", "marketing_start_date": "20200915"}, {"sample": false, "description": "90 TABLET in 1 CONTAINER (43598-345-90)", "package_ndc": "43598-345-90", "marketing_start_date": "20180813"}], "brand_name": "Imatinib", "product_id": "43598-345_38a9944b-db90-72f2-3f0b-7767da490ae2", "dosage_form": "TABLET", "pharm_class": ["Bcr-Abl Tyrosine Kinase Inhibitors [MoA]", "Cytochrome P450 2D6 Inhibitors [MoA]", "Cytochrome P450 3A4 Inhibitors [MoA]", "Kinase Inhibitor [EPC]"], "product_ndc": "43598-345", "generic_name": "Imatinib", "labeler_name": "Dr.Reddy's Laboratories Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Imatinib", "active_ingredients": [{"name": "IMATINIB MESYLATE", "strength": "400 mg/1"}], "application_number": "ANDA206547", "marketing_category": "ANDA", "marketing_start_date": "20180813", "listing_expiration_date": "20261231"}