Home NDC 61269-475-12 XELODA
Product NDC 61269-475
Requested package NDC 61269-475-12
11-digit product format 612690475
Labeler code 61269
Product ID 61269-475_32dd0155-c5cb-49c2-9b74-74f40df22df7
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name capecitabine
Dosage form TABLET, FILM COATED
Route ORAL
Labeler H2-Pharma, LLC
Application NDA020896
Marketing category NDA
Marketing start 1998-04-30
Substance CAPECITABINE
Active strength 500 mg/1
Pharmacologic classes Nucleic Acid Synthesis Inhibitors [MoA], Nucleoside Metabolic Inhibitor [EPC]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 1 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 61269-475 61269-475-12 U Excluded because listing certification expired excluded / ndc_excluded.zip 0efc9e666f02…f202fb6c5f17…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N020896-001 XELODA CAPECITABINE 150MG TABLET / ORAL RLD 1998-04-30 N020896-002 XELODA CAPECITABINE 500MG TABLET / ORAL RLD 1998-04-30
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 1 of 3 · 82 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N020896-001 XELODA 150MG TABLET / ORAL RLD 1998-04-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020896-002 XELODA 500MG TABLET / ORAL RLD 1998-04-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020896-001 XELODA 150MG TABLET / ORAL AB RLD 1998-04-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020896-002 XELODA 500MG TABLET / ORAL AB RLD, RS 1998-04-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020896-001 XELODA 150MG TABLET / ORAL AB RLD 1998-04-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020896-002 XELODA 500MG TABLET / ORAL AB RLD, RS 1998-04-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020896-001 XELODA 150MG TABLET / ORAL AB RLD 1998-04-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020896-002 XELODA 500MG TABLET / ORAL AB RLD, RS 1998-04-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020896-001 XELODA 150MG TABLET / ORAL AB RLD 1998-04-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020896-002 XELODA 500MG TABLET / ORAL AB RLD, RS 1998-04-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020896-001 XELODA 150MG TABLET / ORAL AB RLD 1998-04-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020896-002 XELODA 500MG TABLET / ORAL AB RLD, RS 1998-04-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020896-001 XELODA 150MG TABLET / ORAL AB RLD 1998-04-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020896-002 XELODA 500MG TABLET / ORAL AB RLD, RS 1998-04-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020896-001 XELODA 150MG TABLET / ORAL AB RLD 1998-04-30 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020896-002 XELODA 500MG TABLET / ORAL AB RLD, RS 1998-04-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020896-001 XELODA 150MG TABLET / ORAL AB RLD 1998-04-30 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020896-002 XELODA 500MG TABLET / ORAL AB RLD, RS 1998-04-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N020896-001 XELODA 150MG TABLET / ORAL AB RLD 1998-04-30 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N020896-002 XELODA 500MG TABLET / ORAL AB RLD, RS 1998-04-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020896-001 XELODA 150MG TABLET / ORAL AB RLD 1998-04-30 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020896-002 XELODA 500MG TABLET / ORAL AB RLD, RS 1998-04-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020896-001 XELODA 150MG TABLET / ORAL AB RLD 1998-04-30 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020896-002 XELODA 500MG TABLET / ORAL AB RLD, RS 1998-04-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020896-001 XELODA 150MG TABLET / ORAL AB RLD 1998-04-30 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020896-002 XELODA 500MG TABLET / ORAL AB RLD, RS 1998-04-30 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N020896-001 XELODA 150MG TABLET / ORAL AB RLD 1998-04-30 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N020896-002 XELODA 500MG TABLET / ORAL AB RLD, RS 1998-04-30 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020896-001 XELODA 150MG TABLET / ORAL AB RLD 1998-04-30 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020896-002 XELODA 500MG TABLET / ORAL AB RLD, RS 1998-04-30 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N020896-001 XELODA 150MG TABLET / ORAL AB RLD 1998-04-30 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N020896-002 XELODA 500MG TABLET / ORAL AB RLD, RS 1998-04-30 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N020896-001 XELODA 150MG TABLET / ORAL AB RLD 1998-04-30 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N020896-002 XELODA 500MG TABLET / ORAL AB RLD, RS 1998-04-30 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N020896-001 XELODA 150MG TABLET / ORAL AB RLD 1998-04-30 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N020896-002 XELODA 500MG TABLET / ORAL AB RLD, RS 1998-04-30 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N020896-001 XELODA 150MG TABLET / ORAL AB RLD 1998-04-30 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N020896-002 XELODA 500MG TABLET / ORAL AB RLD, RS 1998-04-30 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N020896-001 XELODA 150MG TABLET / ORAL AB RLD 1998-04-30 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N020896-002 XELODA 500MG TABLET / ORAL AB RLD, RS 1998-04-30 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 78 observed states.
Additional Listing Data#
Finished product Yes
Brand name base XELODA
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CAPECITABINE 500 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 6804DJ8Z9U Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 200327 Internal RxNorm lookup 200328 Internal RxNorm lookup 213292 Internal RxNorm lookup 213293 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 61269-475-12 XELODA 120 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 120 32
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 61269-475 XELODA (CAPECITABINE) TABLET, FILM COATED [H2-PHARMA, LLC] 30 Current NDC, 1 package rows 20250112_e702d84d-7162-4751-bf37-d724cc7e45a5.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 61269-475-12 61269047512 120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (61269-475-12) 1998-04-30 No No Current