capecitabine

Generic: capecitabine

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

Drug Facts

Product Profile

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

capecitabine 150 mg/1

Manufacturer
Dr. Reddy's Laboratories Limited

Identifiers & Regulatory

Product NDC 55111-496
Product ID 55111-496_25eb47d5-42ca-889b-6798-6f91d7795417
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204345
Listing Expiration 2027-12-31
Marketing Start 2020-12-10

Pharmacologic Class

Established (EPC)
nucleoside metabolic inhibitor [epc]
Mechanism of Action
nucleic acid synthesis inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 55111496
Hyphenated Format 55111-496

Supplemental Identifiers

RxCUI
200327 200328
UPC
0355111496601 0355111497042
UNII
6804DJ8Z9U
NUI
N0000000233 N0000175595

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 capecitabine (source: ndc)
Generic Name capecitabine (source: ndc)
Application Number ANDA204345 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 150 mg/1
source: ndc
Packaging
  • 500 TABLET in 1 BOTTLE (55111-496-05)
  • 60 TABLET in 1 BOTTLE (55111-496-60)
source: ndc

Packages (2)

55111-496-05 500 TABLET in 1 BOTTLE (55111-496-05) 55111-496-60 60 TABLET in 1 BOTTLE (55111-496-60)

Ingredients (1)

capecitabine (150 mg/1)

Linked Drug Pages (1)

capecitabine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "25eb47d5-42ca-889b-6798-6f91d7795417", "openfda": {"nui": ["N0000000233", "N0000175595"], "upc": ["0355111496601", "0355111497042"], "unii": ["6804DJ8Z9U"], "rxcui": ["200327", "200328"], "spl_set_id": ["007e3432-c8aa-2a76-52ba-c346924c08a7"], "pharm_class_epc": ["Nucleoside Metabolic Inhibitor [EPC]"], "pharm_class_moa": ["Nucleic Acid Synthesis Inhibitors [MoA]"], "manufacturer_name": ["Dr. Reddy's Laboratories Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 TABLET in 1 BOTTLE (55111-496-05)", "package_ndc": "55111-496-05", "marketing_start_date": "20201210"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (55111-496-60)", "package_ndc": "55111-496-60", "marketing_start_date": "20201210"}], "brand_name": "capecitabine", "product_id": "55111-496_25eb47d5-42ca-889b-6798-6f91d7795417", "dosage_form": "TABLET", "pharm_class": ["Nucleic Acid Synthesis Inhibitors [MoA]", "Nucleoside Metabolic Inhibitor [EPC]"], "product_ndc": "55111-496", "generic_name": "capecitabine", "labeler_name": "Dr. Reddy's Laboratories Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "capecitabine", "active_ingredients": [{"name": "CAPECITABINE", "strength": "150 mg/1"}], "application_number": "ANDA204345", "marketing_category": "ANDA", "marketing_start_date": "20201210", "listing_expiration_date": "20271231"}