Home NDC 0004-1101 Xeloda
Product NDC 0004-1101
11-digit product format 000041101
Labeler code 0004
Product ID 0004-1101_7905031f-2a24-4618-bd70-cf4343ad0a0e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name capecitabine
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Genentech, Inc.
Application NDA020896
Marketing category NDA
Marketing start 1998-04-30
Marketing end 0000-00-00
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 2023-12-31
Current FDA listing Historical FDA.report record 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 · 4 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 0004-1101-50 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 0004-1101-50 f5e01cc5f278…a2eaf40c39c3…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 · 84 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 2026-08-18 06:07:40 2026-07 N020896-001 XELODA 150MG TABLET / ORAL RLD 1998-04-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N020896-002 XELODA 500MG TABLET / ORAL RLD 1998-04-30 caaa826d4ba7…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…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 78 observed states.
DailyMed Product Concepts# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded capecitabine ACTIVE INGREDIENT 6804DJ8Z9U XELODA (CAPECITABINE) TABLET, FILM COATED [GENENTECH, INC.] 12 capecitabine ACTIVE MOIETY 6804DJ8Z9U XELODA (CAPECITABINE) TABLET, FILM COATED [GENENTECH, INC.] 12 anhydrous lactose INACTIVE INGREDIENT 3SY5LH9PMK XELODA (CAPECITABINE) TABLET, FILM COATED [GENENTECH, INC.] 12 cellulose, microcrystalline INACTIVE INGREDIENT OP1R32D61U XELODA (CAPECITABINE) TABLET, FILM COATED [GENENTECH, INC.] 12 croscarmellose sodium INACTIVE INGREDIENT M28OL1HH48 XELODA (CAPECITABINE) TABLET, FILM COATED [GENENTECH, INC.] 12 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 XELODA (CAPECITABINE) TABLET, FILM COATED [GENENTECH, INC.] 12 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT XELODA (CAPECITABINE) TABLET, FILM COATED [GENENTECH, INC.] 12 hypromelloses INACTIVE INGREDIENT 3NXW29V3WO XELODA (CAPECITABINE) TABLET, FILM COATED [GENENTECH, INC.] 12 magnesium stearate INACTIVE INGREDIENT 70097M6I30 XELODA (CAPECITABINE) TABLET, FILM COATED [GENENTECH, INC.] 12 talc INACTIVE INGREDIENT 7SEV7J4R1U XELODA (CAPECITABINE) TABLET, FILM COATED [GENENTECH, INC.] 12 titanium dioxide INACTIVE INGREDIENT 15FIX9V2JP XELODA (CAPECITABINE) TABLET, FILM COATED [GENENTECH, INC.] 12 water INACTIVE INGREDIENT 059QF0KO0R XELODA (CAPECITABINE) TABLET, FILM COATED [GENENTECH, INC.] 12 capecitabine ACTIVE INGREDIENT 6804DJ8Z9U XELODA (CAPECITABINE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 3 capecitabine ACTIVE MOIETY 6804DJ8Z9U XELODA (CAPECITABINE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 3 cellulose, microcrystalline INACTIVE INGREDIENT OP1R32D61U XELODA (CAPECITABINE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 3 croscarmellose sodium INACTIVE INGREDIENT M28OL1HH48 XELODA (CAPECITABINE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 3 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 XELODA (CAPECITABINE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 3 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT XELODA (CAPECITABINE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 3 Hypromellose 2208 (15000 MPA.S) INACTIVE INGREDIENT Z78RG6M2N2 XELODA (CAPECITABINE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 3 magnesium stearate INACTIVE INGREDIENT 70097M6I30 XELODA (CAPECITABINE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 3 talc INACTIVE INGREDIENT 7SEV7J4R1U XELODA (CAPECITABINE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 3 titanium dioxide INACTIVE INGREDIENT 15FIX9V2JP XELODA (CAPECITABINE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 3 water INACTIVE INGREDIENT 059QF0KO0R XELODA (CAPECITABINE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 3 CAPECITABINE ACTIVE INGREDIENT 6804DJ8Z9U XELODA (CAPECITABINE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 capecitabine ACTIVE MOIETY 6804DJ8Z9U XELODA (CAPECITABINE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK XELODA (CAPECITABINE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U XELODA (CAPECITABINE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 XELODA (CAPECITABINE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 XELODA (CAPECITABINE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT XELODA (CAPECITABINE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 HYPROMELLOSE INACTIVE INGREDIENT 3NXW29V3WO XELODA (CAPECITABINE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 HYPROMELLOSE 2208 (15000 CPS) INACTIVE INGREDIENT Z78RG6M2N2 XELODA (CAPECITABINE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 XELODA (CAPECITABINE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 TALC INACTIVE INGREDIENT 7SEV7J4R1U XELODA (CAPECITABINE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP XELODA (CAPECITABINE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 WATER INACTIVE INGREDIENT 059QF0KO0R XELODA (CAPECITABINE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0004-1101 XELODA (CAPECITABINE) TABLET, FILM COATED [GENENTECH, INC.] 29 Legacy NDC 20241124_a1de8bba-3b1d-4c9d-ab8a-32d2c05e67c8.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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join XELODA CAPECITABINE H2-Pharma, LLC e702d84d-7162-4751-bf37-d724cc7e45a5 2026-02-05 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 020896 application number: NDA020896
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 0004-1101-50 00004110150 120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0004-1101-50) 1998-04-30 0000-00-00 No No Current