Home NDC 16714-468-01 CAPECITABINE
Product NDC 16714-468
Requested package NDC 16714-468-01
11-digit product format 167140468
Labeler code 16714
Product ID 16714-468_d6937464-feb2-ada0-e053-2a95a90a3aef
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name CAPECITABINE
Dosage form TABLET, FILM COATED
Route ORAL
Labeler NORTHSTAR RXLLC
Application ANDA202593
Marketing category ANDA
Marketing start 2015-11-01
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 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.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded CAPECITABINE ACTIVE INGREDIENT 6804DJ8Z9U CAPECITABINE TABLET, FILM COATED [NORTHSTAR RXLLC] 1 CAPECITABINE ACTIVE MOIETY 6804DJ8Z9U CAPECITABINE TABLET, FILM COATED [NORTHSTAR RXLLC] 1 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK CAPECITABINE TABLET, FILM COATED [NORTHSTAR RXLLC] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U CAPECITABINE TABLET, FILM COATED [NORTHSTAR RXLLC] 1 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 CAPECITABINE TABLET, FILM COATED [NORTHSTAR RXLLC] 1 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 CAPECITABINE TABLET, FILM COATED [NORTHSTAR RXLLC] 1 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT CAPECITABINE TABLET, FILM COATED [NORTHSTAR RXLLC] 1 HYPROMELLOSE 2910 (5 MPA.S) INACTIVE INGREDIENT R75537T0T4 CAPECITABINE TABLET, FILM COATED [NORTHSTAR RXLLC] 1 HYPROMELLOSE 2910 (6 MPA.S) INACTIVE INGREDIENT 0WZ8WG20P6 CAPECITABINE TABLET, FILM COATED [NORTHSTAR RXLLC] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 CAPECITABINE TABLET, FILM COATED [NORTHSTAR RXLLC] 1 TALC INACTIVE INGREDIENT 7SEV7J4R1U CAPECITABINE TABLET, FILM COATED [NORTHSTAR RXLLC] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP CAPECITABINE TABLET, FILM COATED [NORTHSTAR RXLLC] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 16714-468 CAPECITABINE TABLET, FILM COATED [NORTHSTAR RXLLC] 6 Legacy NDC 20241204_7b260da3-dee2-4bbb-9235-39b16720d578.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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 16714-468-01 16714046801 120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (16714-468-01) 2015-11-01 0000-00-00 No No Current