Home NDC 69097-948 Capecitabine
Product NDC 69097-948
11-digit product format 690970948
Labeler code 69097
Product ID 69097-948_c1549b67-948e-402d-9ba4-6fc16237df8f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Capecitabine
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Cipla USA Inc.
Application ANDA209365
Marketing category ANDA
Marketing start 2023-07-01
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 A209365-001 CAPECITABINE CAPECITABINE 150MG TABLET / ORAL AB 2018-07-02 A209365-002 CAPECITABINE CAPECITABINE 500MG TABLET / ORAL AB 2018-07-02
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 A209365-001 CAPECITABINE 150MG TABLET / ORAL AB 2018-07-02 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A209365-002 CAPECITABINE 500MG TABLET / ORAL AB 2018-07-02 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A209365-001 CAPECITABINE 150MG TABLET / ORAL AB 2018-07-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A209365-002 CAPECITABINE 500MG TABLET / ORAL AB 2018-07-02 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209365-001 CAPECITABINE 150MG TABLET / ORAL AB 2018-07-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209365-002 CAPECITABINE 500MG TABLET / ORAL AB 2018-07-02 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A209365-001 CAPECITABINE 150MG TABLET / ORAL AB 2018-07-02 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A209365-002 CAPECITABINE 500MG TABLET / ORAL AB 2018-07-02 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A209365-001 CAPECITABINE 150MG TABLET / ORAL AB 2018-07-02 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A209365-002 CAPECITABINE 500MG TABLET / ORAL AB 2018-07-02 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A209365-001 CAPECITABINE 150MG TABLET / ORAL AB 2018-07-02 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A209365-002 CAPECITABINE 500MG TABLET / ORAL AB 2018-07-02 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A209365-001 CAPECITABINE 150MG TABLET / ORAL AB 2018-07-02 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A209365-002 CAPECITABINE 500MG TABLET / ORAL AB 2018-07-02 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A209365-001 CAPECITABINE 150MG TABLET / ORAL AB 2018-07-02 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A209365-002 CAPECITABINE 500MG TABLET / ORAL AB 2018-07-02 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A209365-001 CAPECITABINE 150MG TABLET / ORAL AB 2018-07-02 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A209365-002 CAPECITABINE 500MG TABLET / ORAL AB 2018-07-02 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A209365-001 CAPECITABINE 150MG TABLET / ORAL AB 2018-07-02 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A209365-002 CAPECITABINE 500MG TABLET / ORAL AB 2018-07-02 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A209365-001 CAPECITABINE 150MG TABLET / ORAL AB 2018-07-02 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A209365-002 CAPECITABINE 500MG TABLET / ORAL AB 2018-07-02 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A209365-001 CAPECITABINE 150MG TABLET / ORAL AB 2018-07-02 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A209365-002 CAPECITABINE 500MG TABLET / ORAL AB 2018-07-02 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A209365-001 CAPECITABINE 150MG TABLET / ORAL AB 2018-07-02 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A209365-002 CAPECITABINE 500MG TABLET / ORAL AB 2018-07-02 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A209365-001 CAPECITABINE 150MG TABLET / ORAL AB 2018-07-02 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A209365-002 CAPECITABINE 500MG TABLET / ORAL AB 2018-07-02 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A209365-001 CAPECITABINE 150MG TABLET / ORAL AB 2018-07-02 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A209365-002 CAPECITABINE 500MG TABLET / ORAL AB 2018-07-02 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A209365-001 CAPECITABINE 150MG TABLET / ORAL AB 2018-07-02 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A209365-002 CAPECITABINE 500MG TABLET / ORAL AB 2018-07-02 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A209365-001 CAPECITABINE 150MG TABLET / ORAL AB 2018-07-02 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A209365-002 CAPECITABINE 500MG TABLET / ORAL AB 2018-07-02 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A209365-001 CAPECITABINE 150MG TABLET / ORAL AB 2018-07-02 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A209365-002 CAPECITABINE 500MG TABLET / ORAL AB 2018-07-02 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A209365-001 CAPECITABINE 150MG TABLET / ORAL AB 2018-07-02 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A209365-002 CAPECITABINE 500MG TABLET / ORAL AB 2018-07-02 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A209365-001 CAPECITABINE 150MG TABLET / ORAL AB 2018-07-02 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A209365-002 CAPECITABINE 500MG TABLET / ORAL AB 2018-07-02 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 69097-948-08 Capecitabine 120 in 1 BOTTLE TABLET, FILM COATED 120 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69097-948 CAPECITABINE TABLET, FILM COATED [CIPLA USA INC.] 5 Current NDC, Legacy NDC, 1 package rows 20230701_2871c37d-5e55-437b-a434-fc86d845492a.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 69097-948-08 69097094808 120 TABLET, FILM COATED in 1 BOTTLE (69097-948-08) 2023-07-01 0000-00-00 No No Current