Home NDC 72606-555-01 Capecitabine 500mg
Product NDC 72606-555
Requested package NDC 72606-555-01
11-digit product format 726060555
Labeler code 72606
Product ID 72606-555_e38150f6-257d-415d-b90c-09f30f083612
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name CAPECITABINE
Dosage form TABLET, FILM COATED
Route ORAL
Labeler CELLTRION USA, INC.
Application ANDA207456
Marketing category ANDA
Marketing start 2019-11-06
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 2020-12-31
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 · 5 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…
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 A207456-001 CAPECITABINE CAPECITABINE 150MG TABLET / ORAL AB 2016-12-12 A207456-002 CAPECITABINE CAPECITABINE 500MG TABLET / ORAL AB 2016-12-12
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 A207456-001 CAPECITABINE 150MG TABLET / ORAL AB 2016-12-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A207456-002 CAPECITABINE 500MG TABLET / ORAL AB 2016-12-12 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A207456-001 CAPECITABINE 150MG TABLET / ORAL AB 2016-12-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A207456-002 CAPECITABINE 500MG TABLET / ORAL AB 2016-12-12 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207456-001 CAPECITABINE 150MG TABLET / ORAL AB 2016-12-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207456-002 CAPECITABINE 500MG TABLET / ORAL AB 2016-12-12 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A207456-001 CAPECITABINE 150MG TABLET / ORAL AB 2016-12-12 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A207456-002 CAPECITABINE 500MG TABLET / ORAL AB 2016-12-12 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207456-001 CAPECITABINE 150MG TABLET / ORAL AB 2016-12-12 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207456-002 CAPECITABINE 500MG TABLET / ORAL AB 2016-12-12 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207456-001 CAPECITABINE 150MG TABLET / ORAL AB 2016-12-12 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207456-002 CAPECITABINE 500MG TABLET / ORAL AB 2016-12-12 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207456-001 CAPECITABINE 150MG TABLET / ORAL AB 2016-12-12 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207456-002 CAPECITABINE 500MG TABLET / ORAL AB 2016-12-12 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207456-001 CAPECITABINE 150MG TABLET / ORAL AB 2016-12-12 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207456-002 CAPECITABINE 500MG TABLET / ORAL AB 2016-12-12 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207456-001 CAPECITABINE 150MG TABLET / ORAL AB 2016-12-12 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207456-002 CAPECITABINE 500MG TABLET / ORAL AB 2016-12-12 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A207456-001 CAPECITABINE 150MG TABLET / ORAL AB 2016-12-12 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A207456-002 CAPECITABINE 500MG TABLET / ORAL AB 2016-12-12 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A207456-001 CAPECITABINE 150MG TABLET / ORAL AB 2016-12-12 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A207456-002 CAPECITABINE 500MG TABLET / ORAL AB 2016-12-12 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A207456-001 CAPECITABINE 150MG TABLET / ORAL AB 2016-12-12 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A207456-002 CAPECITABINE 500MG TABLET / ORAL AB 2016-12-12 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A207456-001 CAPECITABINE 150MG TABLET / ORAL AB 2016-12-12 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A207456-002 CAPECITABINE 500MG TABLET / ORAL AB 2016-12-12 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A207456-001 CAPECITABINE 150MG TABLET / ORAL AB 2016-12-12 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A207456-002 CAPECITABINE 500MG TABLET / ORAL AB 2016-12-12 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A207456-001 CAPECITABINE 150MG TABLET / ORAL AB 2016-12-12 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A207456-002 CAPECITABINE 500MG TABLET / ORAL AB 2016-12-12 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A207456-001 CAPECITABINE 150MG TABLET / ORAL AB 2016-12-12 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A207456-002 CAPECITABINE 500MG TABLET / ORAL AB 2016-12-12 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A207456-001 CAPECITABINE 150MG TABLET / ORAL AB 2016-12-12 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A207456-002 CAPECITABINE 500MG TABLET / ORAL AB 2016-12-12 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A207456-001 CAPECITABINE 150MG TABLET / ORAL AB 2016-12-12 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A207456-002 CAPECITABINE 500MG TABLET / ORAL AB 2016-12-12 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A207456-001 CAPECITABINE 150MG TABLET / ORAL AB 2016-12-12 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A207456-002 CAPECITABINE 500MG TABLET / ORAL AB 2016-12-12 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A207456-001 CAPECITABINE 150MG TABLET / ORAL AB 2016-12-12 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A207456-002 CAPECITABINE 500MG TABLET / ORAL AB 2016-12-12 bb7c543d1eb4…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 84 observed states.
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 · 2 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 72606-555-01 72606055501 120 TABLET, FILM COATED in 1 BOTTLE (72606-555-01) 2019-11-06 0000-00-00 No No Current