Capecitabine
- Product NDC
- 63759-3000
- 11-digit product format
- 637593000
- Labeler code
- 63759
- Product ID
- 63759-3000_35f3619e-3301-4410-8de1-33ae333b56d5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Capecitabine
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Shilpa Medicare Limited
- Application
- ANDA207456
- Marketing category
- ANDA
- Marketing start
- 2016-12-31
- Marketing end
- 0000-00-00
- Substance
- CAPECITABINE
- Active strength
- 150 mg/1
- Pharmacologic classes
- Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2019-12-31
- Current FDA listing
- Historical FDA.report record
Orange Book products#
| 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#
| Application-product | TE code |
|---|---|
| A207456-001 | AB |
| A207456-002 | AB |
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.
| 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#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A207456-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A207456-002 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A207456-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A207456-002 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A207456-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A207456-002 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A207456-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A207456-002 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A207456-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A207456-002 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A207456-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A207456-002 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A207456-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A207456-002 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A207456-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A207456-002 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A207456-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A207456-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A207456-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A207456-002 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A207456-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A207456-002 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A207456-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A207456-002 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A207456-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A207456-002 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A207456-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A207456-002 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A207456-001 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A207456-002 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A207456-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A207456-002 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A207456-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A207456-002 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A207456-001 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A207456-002 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A207456-001 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A207456-002 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A207456-001 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A207456-002 | AB | 1 | bb7c543d1eb4… |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Capecitabine 500mg | CAPECITABINE | Armas Pharmaceuticals Inc. | f050d16c-ab76-489d-b92c-8c155b4e3f7c | 2020-12-26 | Boxed warning, Warnings, Adverse reactions | 207456 ANDA207456 |
| Capecitabine 150mg | CAPECITABINE | Armas Pharmaceuticals Inc. | 7f555b6b-60db-45e2-a61e-537e57f43fdc | 2020-12-22 | Boxed warning, Warnings, Adverse reactions | 207456 ANDA207456 |