Home NDC 16729-073 CAPECITABINE
Product NDC 16729-073
11-digit product format 167290073
Labeler code 16729
Product ID 16729-073_0e1e6b8e-1e8f-3b26-e063-6294a90ad5fb
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name CAPECITABINE
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Accord Healthcare Inc.
Application ANDA202593
Marketing category ANDA
Marketing start 2015-05-20
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 2026-12-31
Current FDA listing Yes 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 A202593-001 CAPECITABINE CAPECITABINE 150MG TABLET / ORAL AB 2015-04-23 A202593-002 CAPECITABINE CAPECITABINE 500MG TABLET / ORAL AB 2015-04-23
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 A202593-001 CAPECITABINE 150MG TABLET / ORAL AB 2015-04-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A202593-002 CAPECITABINE 500MG TABLET / ORAL AB 2015-04-23 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A202593-001 CAPECITABINE 150MG TABLET / ORAL AB 2015-04-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A202593-002 CAPECITABINE 500MG TABLET / ORAL AB 2015-04-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202593-001 CAPECITABINE 150MG TABLET / ORAL AB 2015-04-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202593-002 CAPECITABINE 500MG TABLET / ORAL AB 2015-04-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A202593-001 CAPECITABINE 150MG TABLET / ORAL AB 2015-04-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A202593-002 CAPECITABINE 500MG TABLET / ORAL AB 2015-04-23 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202593-001 CAPECITABINE 150MG TABLET / ORAL AB 2015-04-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202593-002 CAPECITABINE 500MG TABLET / ORAL AB 2015-04-23 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202593-001 CAPECITABINE 150MG TABLET / ORAL AB 2015-04-23 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202593-002 CAPECITABINE 500MG TABLET / ORAL AB 2015-04-23 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A202593-001 CAPECITABINE 150MG TABLET / ORAL AB 2015-04-23 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A202593-002 CAPECITABINE 500MG TABLET / ORAL AB 2015-04-23 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A202593-001 CAPECITABINE 150MG TABLET / ORAL AB 2015-04-23 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A202593-002 CAPECITABINE 500MG TABLET / ORAL AB 2015-04-23 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A202593-001 CAPECITABINE 150MG TABLET / ORAL AB 2015-04-23 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A202593-002 CAPECITABINE 500MG TABLET / ORAL AB 2015-04-23 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A202593-001 CAPECITABINE 150MG TABLET / ORAL AB 2015-04-23 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A202593-002 CAPECITABINE 500MG TABLET / ORAL AB 2015-04-23 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A202593-001 CAPECITABINE 150MG TABLET / ORAL AB 2015-04-23 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A202593-002 CAPECITABINE 500MG TABLET / ORAL AB 2015-04-23 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A202593-001 CAPECITABINE 150MG TABLET / ORAL AB 2015-04-23 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A202593-002 CAPECITABINE 500MG TABLET / ORAL AB 2015-04-23 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A202593-001 CAPECITABINE 150MG TABLET / ORAL AB 2015-04-23 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A202593-002 CAPECITABINE 500MG TABLET / ORAL AB 2015-04-23 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A202593-001 CAPECITABINE 150MG TABLET / ORAL AB 2015-04-23 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A202593-002 CAPECITABINE 500MG TABLET / ORAL AB 2015-04-23 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A202593-001 CAPECITABINE 150MG TABLET / ORAL AB 2015-04-23 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A202593-002 CAPECITABINE 500MG TABLET / ORAL AB 2015-04-23 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A202593-001 CAPECITABINE 150MG TABLET / ORAL AB 2015-04-23 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A202593-002 CAPECITABINE 500MG TABLET / ORAL AB 2015-04-23 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A202593-001 CAPECITABINE 150MG TABLET / ORAL AB 2015-04-23 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A202593-002 CAPECITABINE 500MG TABLET / ORAL AB 2015-04-23 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A202593-001 CAPECITABINE 150MG TABLET / ORAL AB 2015-04-23 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A202593-002 CAPECITABINE 500MG TABLET / ORAL AB 2015-04-23 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A202593-001 CAPECITABINE 150MG TABLET / ORAL AB 2015-04-23 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A202593-002 CAPECITABINE 500MG TABLET / ORAL AB 2015-04-23 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A202593-001 CAPECITABINE 150MG TABLET / ORAL AB 2015-04-23 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A202593-002 CAPECITABINE 500MG TABLET / ORAL AB 2015-04-23 bb7c543d1eb4…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 84 observed states.
Additional Listing Data#
Finished product Yes
Brand name base CAPECITABINE
Listing expiration 2026-12-31 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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 200327 Internal RxNorm lookup 200328 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 16729-073-29 CAPECITABINE 120 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 120 13
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded CAPECITABINE ACTIVE INGREDIENT 6804DJ8Z9U CAPECITABINE TABLET, FILM COATED [ACCORD HEALTHCARE INC.] 4 CAPECITABINE ACTIVE MOIETY 6804DJ8Z9U CAPECITABINE TABLET, FILM COATED [ACCORD HEALTHCARE INC.] 4 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK CAPECITABINE TABLET, FILM COATED [ACCORD HEALTHCARE INC.] 4 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U CAPECITABINE TABLET, FILM COATED [ACCORD HEALTHCARE INC.] 4 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 CAPECITABINE TABLET, FILM COATED [ACCORD HEALTHCARE INC.] 4 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 CAPECITABINE TABLET, FILM COATED [ACCORD HEALTHCARE INC.] 4 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT CAPECITABINE TABLET, FILM COATED [ACCORD HEALTHCARE INC.] 4 HYPROMELLOSE 2910 (5 MPA.S) INACTIVE INGREDIENT R75537T0T4 CAPECITABINE TABLET, FILM COATED [ACCORD HEALTHCARE INC.] 4 HYPROMELLOSE 2910 (6 MPA.S) INACTIVE INGREDIENT 0WZ8WG20P6 CAPECITABINE TABLET, FILM COATED [ACCORD HEALTHCARE INC.] 4 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 CAPECITABINE TABLET, FILM COATED [ACCORD HEALTHCARE INC.] 4 TALC INACTIVE INGREDIENT 7SEV7J4R1U CAPECITABINE TABLET, FILM COATED [ACCORD HEALTHCARE INC.] 4 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP CAPECITABINE TABLET, FILM COATED [ACCORD HEALTHCARE INC.] 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 16729-073 CAPECITABINE TABLET, FILM COATED [ACCORD HEALTHCARE INC.] 13 Current NDC, Legacy NDC, 1 package rows 20240105_8345d55e-ad02-4726-a04b-1a46e3337a4b.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 · 2 matching rows.
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 16729-073-29 16729007329 120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (16729-073-29) 2015-05-20 0000-00-00 No No Current