Home NDC 0093-7474 Capecitabine
Product NDC 0093-7474
11-digit product format 000937474
Labeler code 0093
Product ID 0093-7474_94cd2146-70ff-43e3-a896-b9e55d75540f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Capecitabine
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Teva Pharmaceuticals USA, Inc.
Application ANDA091649
Marketing category ANDA
Marketing start 2014-03-07
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 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 A091649-001 CAPECITABINE CAPECITABINE 150MG TABLET / ORAL AB 2013-09-16 A091649-002 CAPECITABINE CAPECITABINE 500MG TABLET / ORAL AB 2013-09-16
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 · 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 A091649-001 CAPECITABINE 150MG TABLET / ORAL AB 2013-09-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A091649-002 CAPECITABINE 500MG TABLET / ORAL AB 2013-09-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091649-001 CAPECITABINE 150MG TABLET / ORAL AB 2013-09-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091649-002 CAPECITABINE 500MG TABLET / ORAL AB 2013-09-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A091649-001 CAPECITABINE 150MG TABLET / ORAL AB 2013-09-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A091649-002 CAPECITABINE 500MG TABLET / ORAL AB 2013-09-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091649-001 CAPECITABINE 150MG TABLET / ORAL AB 2013-09-16 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091649-002 CAPECITABINE 500MG TABLET / ORAL AB 2013-09-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091649-001 CAPECITABINE 150MG TABLET / ORAL AB 2013-09-16 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091649-002 CAPECITABINE 500MG TABLET / ORAL AB 2013-09-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091649-001 CAPECITABINE 150MG TABLET / ORAL AB 2013-09-16 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091649-002 CAPECITABINE 500MG TABLET / ORAL AB 2013-09-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091649-001 CAPECITABINE 150MG TABLET / ORAL AB 2013-09-16 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091649-002 CAPECITABINE 500MG TABLET / ORAL AB 2013-09-16 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091649-001 CAPECITABINE 150MG TABLET / ORAL AB 2013-09-16 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091649-002 CAPECITABINE 500MG TABLET / ORAL AB 2013-09-16 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091649-001 CAPECITABINE 150MG TABLET / ORAL AB 2013-09-16 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091649-002 CAPECITABINE 500MG TABLET / ORAL AB 2013-09-16 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A091649-001 CAPECITABINE 150MG TABLET / ORAL AB 2013-09-16 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A091649-002 CAPECITABINE 500MG TABLET / ORAL AB 2013-09-16 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091649-001 CAPECITABINE 150MG TABLET / ORAL AB 2013-09-16 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091649-002 CAPECITABINE 500MG TABLET / ORAL AB 2013-09-16 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A091649-001 CAPECITABINE 150MG TABLET / ORAL AB 2013-09-16 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A091649-002 CAPECITABINE 500MG TABLET / ORAL AB 2013-09-16 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A091649-001 CAPECITABINE 150MG TABLET / ORAL AB 2013-09-16 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A091649-002 CAPECITABINE 500MG TABLET / ORAL AB 2013-09-16 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A091649-001 CAPECITABINE 150MG TABLET / ORAL AB 2013-09-16 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A091649-002 CAPECITABINE 500MG TABLET / ORAL AB 2013-09-16 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A091649-001 CAPECITABINE 150MG TABLET / ORAL AB 2013-09-16 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A091649-002 CAPECITABINE 500MG TABLET / ORAL AB 2013-09-16 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A091649-001 CAPECITABINE 150MG TABLET / ORAL AB 2013-09-16 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A091649-002 CAPECITABINE 500MG TABLET / ORAL AB 2013-09-16 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A091649-001 CAPECITABINE 150MG TABLET / ORAL AB 2013-09-16 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A091649-002 CAPECITABINE 500MG TABLET / ORAL AB 2013-09-16 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A091649-001 CAPECITABINE 150MG TABLET / ORAL AB 2013-09-16 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A091649-002 CAPECITABINE 500MG TABLET / ORAL AB 2013-09-16 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A091649-001 CAPECITABINE 150MG TABLET / ORAL AB 2013-09-16 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A091649-002 CAPECITABINE 500MG TABLET / ORAL AB 2013-09-16 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A091649-001 CAPECITABINE 150MG TABLET / ORAL AB 2013-09-16 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A091649-002 CAPECITABINE 500MG TABLET / ORAL AB 2013-09-16 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 82 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Capecitabine
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 · 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 0093-7474-89 Capecitabine 120 in 1 BOTTLE TABLET, FILM COATED 120 14
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded CAPECITABINE ACTIVE INGREDIENT 6804DJ8Z9U CAPECITABINE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 4 CAPECITABINE ACTIVE MOIETY 6804DJ8Z9U CAPECITABINE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 4 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK CAPECITABINE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 4 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U CAPECITABINE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 4 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 CAPECITABINE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 4 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 CAPECITABINE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 4 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT CAPECITABINE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 4 HYPROMELLOSE 2910 (3 MPA.S) INACTIVE INGREDIENT 0VUT3PMY82 CAPECITABINE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 4 HYPROMELLOSE 2910 (6 MPA.S) INACTIVE INGREDIENT 0WZ8WG20P6 CAPECITABINE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 4 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 CAPECITABINE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 4 TALC INACTIVE INGREDIENT 7SEV7J4R1U CAPECITABINE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 4 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP CAPECITABINE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 4 CAPECITABINE ACTIVE INGREDIENT 6804DJ8Z9U CAPECITABINE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] 1 CAPECITABINE ACTIVE MOIETY 6804DJ8Z9U CAPECITABINE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] 1 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK CAPECITABINE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U CAPECITABINE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] 1 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 CAPECITABINE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] 1 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 CAPECITABINE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] 1 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT CAPECITABINE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] 1 HYPROMELLOSE 2910 (3 MPA.S) INACTIVE INGREDIENT 0VUT3PMY82 CAPECITABINE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] 1 HYPROMELLOSE 2910 (6 MPA.S) INACTIVE INGREDIENT 0WZ8WG20P6 CAPECITABINE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 CAPECITABINE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] 1 TALC INACTIVE INGREDIENT 7SEV7J4R1U CAPECITABINE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP CAPECITABINE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0093-7474 CAPECITABINE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA, INC.] 13 Current NDC, Legacy NDC, 1 package rows 20240815_5753679a-506c-4ac4-b8b2-b27c664d1d40.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 · 3 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Capecitabine CAPECITABINE Golden State Medical Supply, Inc. e28a5ef7-4731-f8ac-e053-2995a90a21bf 2026-04-16 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 091649 application number: ANDA091649 Capecitabine CAPECITABINE Teva Pharmaceuticals USA, Inc. 5753679a-506c-4ac4-b8b2-b27c664d1d40 2025-12-31 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 091649 application number: ANDA091649 ndc (product): 0093-7474 Capecitabine CAPECITABINE American Health Packaging 2777b481-7d7f-461a-b5e0-c09ce2990c34 2025-08-20 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 091649 application number: ANDA091649
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 0093-7474-89 00093747489 120 TABLET, FILM COATED in 1 BOTTLE (0093-7474-89) 2014-03-07 0000-00-00 No No Current