Colcrys
- Product NDC
- 43353-854
- Requested package NDC
- 43353-854-09
- 11-digit product format
- 433530854
- Labeler code
- 43353
- Product ID
- 43353-854_9d38ee67-c179-48c6-8280-075fd7919069
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Colchicine
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Aphena Pharma Solutions - Tennessee, LLC
- Application
- NDA022352
- Marketing category
- NDA
- Marketing start
- 2009-09-01
- Marketing end
- 0000-00-00
- Substance
- COLCHICINE
- Active strength
- 1 mg/1
- Pharmacologic classes
- Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Interactions [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2020-12-31
- Current FDA listing
- Historical FDA.report record
NDC auxiliary status#
These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded package | package | 43353-854 | 43353-854-09 | I | Inactivated by FDA | 2026-08-11 |
Observed NDC auxiliary status history#
This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
| Captured / source date | Snapshot | Source SHA-256 |
|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-05-28 21:12 UTC · source 2024-05-28 | 8af77b9d5b6f… | d9bbb34c5368… |
| 2024-05-15 03:39 UTC · source 2024-05-14 | 834df4deac94… | adcc014656a3… |
| 2024-03-11 06:39 UTC · source 2024-03-08 | 1332a3947898… | d4bfe170f9cd… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N022352-001 | COLCRYS | COLCHICINE | 0.6MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2009-07-29 |
Orange Book patents#
| Application-product | Patent | Expiration | Use code | Coverage / status | Submission date |
|---|---|---|---|---|---|
| N022352-001 | 7964647 | 2028-10-06 | U-1007 | 2011-06-24 | |
| N022352-001 | 7964648 | 2028-10-06 | U-1161 | 2011-06-24 | |
| N022352-001 | 7981938 | 2028-10-06 | U-1166 | 2011-07-22 | |
| N022352-001 | 8093296 | 2028-10-06 | U-1007 | 2012-01-13 | |
| N022352-001 | 8093297 | 2028-10-06 | U-1161 | 2012-01-13 | |
| N022352-001 | 8093298 | 2028-10-06 | U-1116 | 2012-01-13 | |
| N022352-001 | 8097655 | 2028-10-06 | U-1020 | 2012-01-27 | |
| N022352-001 | 8415395 | 2028-10-06 | U-1007 | 2013-05-08 | |
| N022352-001 | 8415396 | 2028-10-06 | U-1007 | 2013-05-08 | |
| N022352-001 | 7619004 | 2028-12-03 | U-1020 | ||
| N022352-001 | 7935731 | 2028-12-03 | U-1116 | 2011-06-24 | |
| N022352-001 | 7601758 | 2029-02-10 | U-1007 | ||
| N022352-001 | 7820681 | 2029-02-17 | U-1020 | ||
| N022352-001 | 7906519 | 2029-02-17 | U-1116 | ||
| N022352-001 | 7915269 | 2029-02-17 | U-1007 | ||
| N022352-001 | 8440721 | 2029-02-17 | U-1007 | 2013-06-10 | |
| N022352-001 | 8440722 | 2029-02-17 | U-1020 | 2013-06-10 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | N022352-001 | COLCRYS | 0.6MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2009-07-29 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022352-001 | COLCRYS | 0.6MG | TABLET / ORAL | RLD | 2009-07-29 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N022352-001 | COLCRYS | 0.6MG | TABLET / ORAL | RLD | 2009-07-29 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022352-001 | COLCRYS | 0.6MG | TABLET / ORAL | RLD | 2009-07-29 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022352-001 | COLCRYS | 0.6MG | TABLET / ORAL | RLD | 2009-07-29 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022352-001 | COLCRYS | 0.6MG | TABLET / ORAL | RLD | 2009-07-29 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022352-001 | COLCRYS | 0.6MG | TABLET / ORAL | RLD | 2009-07-29 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N022352-001 | COLCRYS | 0.6MG | TABLET / ORAL | RLD | 2009-07-29 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N022352-001 | COLCRYS | 0.6MG | TABLET / ORAL | RLD | 2009-07-29 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N022352-001 | COLCRYS | 0.6MG | TABLET / ORAL | RLD | 2009-07-29 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N022352-001 | COLCRYS | 0.6MG | TABLET / ORAL | RLD | 2009-07-29 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N022352-001 | COLCRYS | 0.6MG | TABLET / ORAL | RLD | 2009-07-29 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N022352-001 | COLCRYS | 0.6MG | TABLET / ORAL | RLD | 2009-07-29 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N022352-001 | COLCRYS | 0.6MG | TABLET / ORAL | AB | RLD, RS | 2009-07-29 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N022352-001 | COLCRYS | 0.6MG | TABLET / ORAL | AB | RLD, RS | 2009-07-29 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | N022352-001 | COLCRYS | 0.6MG | TABLET / ORAL | AB | RLD, RS | 2009-07-29 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | N022352-001 | COLCRYS | 0.6MG | TABLET / ORAL | AB | RLD, RS | 2009-07-29 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | N022352-001 | COLCRYS | 0.6MG | TABLET / ORAL | AB | RLD, RS | 2009-07-29 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | N022352-001 | COLCRYS | 0.6MG | TABLET / ORAL | AB | RLD, RS | 2009-07-29 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | N022352-001 | COLCRYS | 0.6MG | TABLET / ORAL | AB | RLD, RS | 2009-07-29 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N022352-001 | COLCRYS | 0.6MG | TABLET / ORAL | AB | RLD, RS | 2009-07-29 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | N022352-001 | COLCRYS | 0.6MG | TABLET / ORAL | AB | RLD, RS | 2009-07-29 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | N022352-001 | COLCRYS | 0.6MG | TABLET / ORAL | AB | RLD, RS | 2009-07-29 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | N022352-001 | COLCRYS | 0.6MG | TABLET / ORAL | AB | RLD, RS | 2009-07-29 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | N022352-001 | COLCRYS | 0.6MG | TABLET / ORAL | AB | RLD, RS | 2009-07-29 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | N022352-001 | COLCRYS | 0.6MG | TABLET / ORAL | AB | RLD, RS | 2009-07-29 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | N022352-001 | COLCRYS | 0.6MG | TABLET / ORAL | AB | RLD, RS | 2009-07-29 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N022352-001 | COLCRYS | 0.6MG | TABLET / ORAL | AB | RLD, RS | 2009-07-29 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | N022352-001 | COLCRYS | 0.6MG | TABLET / ORAL | AB | RLD, RS | 2009-07-29 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | N022352-001 | COLCRYS | 0.6MG | TABLET / ORAL | AB | RLD, RS | 2009-07-29 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N022352-001 | COLCRYS | 0.6MG | TABLET / ORAL | AB | RLD, RS | 2009-07-29 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N022352-001 | COLCRYS | 0.6MG | TABLET / ORAL | AB | RLD, RS | 2009-07-29 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N022352-001 | COLCRYS | 0.6MG | TABLET / ORAL | AB | RLD, RS | 2009-07-29 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N022352-001 | COLCRYS | 0.6MG | TABLET / ORAL | AB | RLD, RS | 2009-07-29 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | N022352-001 | COLCRYS | 0.6MG | TABLET / ORAL | AB | RLD, RS | 2009-07-29 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | N022352-001 | COLCRYS | 0.6MG | TABLET / ORAL | AB | RLD, RS | 2009-07-29 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N022352-001 | COLCRYS | 0.6MG | TABLET / ORAL | AB | RLD, RS | 2009-07-29 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | N022352-001 | COLCRYS | 0.6MG | TABLET / ORAL | AB | RLD, RS | 2009-07-29 | f41ea6bd6efb… |
| 2022-09-29 23:25 UTC | 2022-09 | N022352-001 | COLCRYS | 0.6MG | TABLET / ORAL | AB | RLD, RS | 2009-07-29 | e64feba35796… |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | N022352-001 | COLCRYS | 0.6MG | TABLET / ORAL | AB | RLD, RS | 2009-07-29 | cb3db0bc1861… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2024-05-31 18:47 UTC | 2024-05 | N022352-001 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N022352-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | N022352-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | N022352-001 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | N022352-001 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | N022352-001 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | N022352-001 | AB | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N022352-001 | AB | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | N022352-001 | AB | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | N022352-001 | AB | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | N022352-001 | AB | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | N022352-001 | AB | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | N022352-001 | AB | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | N022352-001 | AB | 1 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N022352-001 | AB | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | N022352-001 | AB | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | N022352-001 | AB | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N022352-001 | AB | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N022352-001 | AB | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N022352-001 | AB | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N022352-001 | AB | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | N022352-001 | AB | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | N022352-001 | AB | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N022352-001 | AB | 1 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | N022352-001 | AB | 1 | f41ea6bd6efb… |
| 2022-09-29 23:25 UTC | 2022-09 | N022352-001 | AB | 1 | e64feba35796… |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | N022352-001 | AB | 1 | cb3db0bc1861… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | N022352-001 | 7964647 | 2028-10-06 | U-1007 | 2011-06-24 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N022352-001 | 7964648 | 2028-10-06 | U-1161 | 2011-06-24 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N022352-001 | 7981938 | 2028-10-06 | U-1166 | 2011-07-22 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N022352-001 | 8093296 | 2028-10-06 | U-1007 | 2012-01-13 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N022352-001 | 8093297 | 2028-10-06 | U-1161 | 2012-01-13 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N022352-001 | 8093298 | 2028-10-06 | U-1116 | 2012-01-13 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N022352-001 | 8097655 | 2028-10-06 | U-1020 | 2012-01-27 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N022352-001 | 8415395 | 2028-10-06 | U-1007 | 2013-05-08 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N022352-001 | 8415396 | 2028-10-06 | U-1007 | 2013-05-08 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N022352-001 | 7619004 | 2028-12-03 | U-1020 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N022352-001 | 7935731 | 2028-12-03 | U-1116 | 2011-06-24 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N022352-001 | 7601758 | 2029-02-10 | U-1007 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N022352-001 | 7820681 | 2029-02-17 | U-1020 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N022352-001 | 7906519 | 2029-02-17 | U-1116 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N022352-001 | 7915269 | 2029-02-17 | U-1007 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N022352-001 | 8440721 | 2029-02-17 | U-1007 | 2013-06-10 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N022352-001 | 8440722 | 2029-02-17 | U-1020 | 2013-06-10 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022352-001 | 7964647 | 2028-10-06 | U-1007 | 2011-06-24 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022352-001 | 7964648 | 2028-10-06 | U-1161 | 2011-06-24 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022352-001 | 7981938 | 2028-10-06 | U-1166 | 2011-07-22 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022352-001 | 8093296 | 2028-10-06 | U-1007 | 2012-01-13 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022352-001 | 8093297 | 2028-10-06 | U-1161 | 2012-01-13 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022352-001 | 8093298 | 2028-10-06 | U-1116 | 2012-01-13 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022352-001 | 8097655 | 2028-10-06 | U-1020 | 2012-01-27 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022352-001 | 8415395 | 2028-10-06 | U-1007 | 2013-05-08 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022352-001 | 8415396 | 2028-10-06 | U-1007 | 2013-05-08 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022352-001 | 7619004 | 2028-12-03 | U-1020 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022352-001 | 7935731 | 2028-12-03 | U-1116 | 2011-06-24 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022352-001 | 7601758 | 2029-02-10 | U-1007 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022352-001 | 7820681 | 2029-02-17 | U-1020 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022352-001 | 7906519 | 2029-02-17 | U-1116 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022352-001 | 7915269 | 2029-02-17 | U-1007 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022352-001 | 8440721 | 2029-02-17 | U-1007 | 2013-06-10 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022352-001 | 8440722 | 2029-02-17 | U-1020 | 2013-06-10 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N022352-001 | 7964647 | 2028-10-06 | U-1007 | 2011-06-24 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N022352-001 | 7964648 | 2028-10-06 | U-1161 | 2011-06-24 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N022352-001 | 7981938 | 2028-10-06 | U-1166 | 2011-07-22 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N022352-001 | 8093296 | 2028-10-06 | U-1007 | 2012-01-13 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N022352-001 | 8093297 | 2028-10-06 | U-1161 | 2012-01-13 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N022352-001 | 8093298 | 2028-10-06 | U-1116 | 2012-01-13 | 6a471c1ec25d… |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 51989a2b-944a-b31f-835e-469c133570ad | Product name | 2 | 20250716 |
| 11e940b0-77bd-45d4-a80f-028ff6bd67e2 | Product name | 2 | 20250214 |
| 14efe2b0-2695-4943-8b2f-24f519c99fed | Product name | 1 | 20231023 |
| bf4e8ffd-8f13-3050-5248-581676b7ea42 | Product name | 6 | 20221214 |
| 987af351-b977-4822-ac44-c76d29e24e78 | Product name | 1 | 20190611 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 43353-854-09 | 2023-01-30 | C162847 | 48780-1 | f386c649-fa6d-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use colchicine safely and effectively. See full prescribing information for COLCRYS ® . COLCRYS ® (colchicine, USP) tablets for Oral use Initial U.S. Approval: 1961 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 43353-854-09 | Colcrys | 9000 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 9000 | 2 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 43353-854-09 | EA - Each | 43353-854 | 3437f4be-4eb3-4a11-9372-174c0c9556d5 | 1 | 2014-05-02 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
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 |
|---|---|---|---|---|---|---|
| COLCHICINE | COLCHICINE | direct rx | c7d013b7-0a67-0953-e053-2a95a90ac47c | 2025-01-20 | Warnings, Adverse reactions | 022352 NDA022352 |
| Colchicine | COLCHICINE | Bryant Ranch Prepack | a15538ee-d1eb-4118-97c3-53748cea012a | 2024-05-22 | Warnings, Adverse reactions | 022352 NDA022352 |
| Colchicine | COLCHICINE | Bryant Ranch Prepack | df1dd89a-a1b3-48e8-b0e8-ad71b4cb0c96 | 2024-01-10 | Warnings, Adverse reactions | 022352 NDA022352 |
| Colchicine | COLCHICINE | Bryant Ranch Prepack | 5e5d9488-d9d0-4b37-b535-941d66c3430d | 2024-01-10 | Warnings, Adverse reactions | 022352 NDA022352 |
| Colcrys | COLCHICINE | Proficient Rx LP | d6adc880-5499-4691-93f3-27c87902d5fc | 2022-10-01 | Warnings, Adverse reactions | 022352 NDA022352 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 197541 | colchicine 0.6 MG Oral Tablet | PSN | a80036fe-3016-4541-aa42-6c06cf37ae55 | 2 |
| 858071 | Colcrys 0.6 MG Oral Tablet | PSN | a80036fe-3016-4541-aa42-6c06cf37ae55 | 2 |
| 858071 | colchicine 0.6 MG Oral Tablet [Colcrys] | SBD | a80036fe-3016-4541-aa42-6c06cf37ae55 | 2 |
| 197541 | colchicine 0.6 MG Oral Tablet | SCD | a80036fe-3016-4541-aa42-6c06cf37ae55 | 2 |
| 197541 | colchicine 600 MCG Oral Tablet | SY | a80036fe-3016-4541-aa42-6c06cf37ae55 | 2 |
| 858071 | Colcrys (colchicine 0.6 MG) Oral Tablet | SY | a80036fe-3016-4541-aa42-6c06cf37ae55 | 2 |
| 858071 | Colcrys 0.6 MG Oral Tablet | SY | a80036fe-3016-4541-aa42-6c06cf37ae55 | 2 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 43353-854-09 | 43353085409 | 9000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43353-854-09) | 2013-07-02 | 0000-00-00 | No | No | Current |