Home NDC 75854-801-01 Gloperba
Product NDC 75854-801
Requested package NDC 75854-801-01
11-digit product format 758540801
Labeler code 75854
Product ID 75854-801_b85547d8-fce6-323d-e053-2995a90a4e7e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name colchicine
Dosage form SOLUTION
Route ORAL
Labeler Avion Pharmaceuticals, LLC
Application NDA210942
Marketing category NDA
Marketing start 2019-08-01
Marketing end 0000-00-00
Substance COLCHICINE
Active strength 1 mg/5mL
Pharmacologic classes Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Interactions [MoA]
NDC exclude flag No
Listing certified through 2022-12-31
Current FDA listing Historical FDA.report record 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.
Historic NDC status page 1 of 1 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table 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…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N210942-001 GLOPERBA COLCHICINE 0.6MG/5ML SOLUTION / ORAL RLD, RS 2019-01-30
Orange Book patents# Current patent rows page 1 of 1 · 6 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N210942-001 10383820 2036-11-22 U-2814 Drug product 2019-08-28 N210942-001 10383821 2036-11-22 Drug product 2019-08-28 N210942-001 12274751 2036-11-22 U-2814 2025-04-25 N210942-001 12514819 2036-11-22 U-2814 2026-02-03 N210942-001 9907751 2036-11-22 Drug product 2019-02-26 N210942-001 10226423 2037-12-20 Drug product 2019-03-27
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 2 · 41 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 N210942-001 GLOPERBA 0.6MG/5ML SOLUTION / ORAL RLD, RS 2019-01-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210942-001 GLOPERBA 0.6MG/5ML SOLUTION / ORAL RLD, RS 2019-01-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N210942-001 GLOPERBA 0.6MG/5ML SOLUTION / ORAL RLD, RS 2019-01-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210942-001 GLOPERBA 0.6MG/5ML SOLUTION / ORAL RLD, RS 2019-01-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N210942-001 GLOPERBA 0.6MG/5ML SOLUTION / ORAL RLD, RS 2019-01-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N210942-001 GLOPERBA 0.6MG/5ML SOLUTION / ORAL RLD, RS 2019-01-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N210942-001 GLOPERBA 0.6MG/5ML SOLUTION / ORAL RLD, RS 2019-01-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N210942-001 GLOPERBA 0.6MG/5ML SOLUTION / ORAL RLD, RS 2019-01-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N210942-001 GLOPERBA 0.6MG/5ML SOLUTION / ORAL RLD, RS 2019-01-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N210942-001 GLOPERBA 0.6MG/5ML SOLUTION / ORAL RLD, RS 2019-01-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N210942-001 GLOPERBA 0.6MG/5ML SOLUTION / ORAL RLD, RS 2019-01-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N210942-001 GLOPERBA 0.6MG/5ML SOLUTION / ORAL RLD, RS 2019-01-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N210942-001 GLOPERBA 0.6MG/5ML SOLUTION / ORAL RLD, RS 2019-01-30 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N210942-001 GLOPERBA 0.6MG/5ML SOLUTION / ORAL RLD, RS 2019-01-30 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N210942-001 GLOPERBA 0.6MG/5ML SOLUTION / ORAL RLD, RS 2019-01-30 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N210942-001 GLOPERBA 0.6MG/5ML SOLUTION / ORAL RLD, RS 2019-01-30 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N210942-001 GLOPERBA 0.6MG/5ML SOLUTION / ORAL RLD, RS 2019-01-30 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N210942-001 GLOPERBA 0.6MG/5ML SOLUTION / ORAL RLD, RS 2019-01-30 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N210942-001 GLOPERBA 0.6MG/5ML SOLUTION / ORAL RLD, RS 2019-01-30 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N210942-001 GLOPERBA 0.6MG/5ML SOLUTION / ORAL RLD, RS 2019-01-30 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N210942-001 GLOPERBA 0.6MG/5ML SOLUTION / ORAL RLD, RS 2019-01-30 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N210942-001 GLOPERBA 0.6MG/5ML SOLUTION / ORAL RLD, RS 2019-01-30 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N210942-001 GLOPERBA 0.6MG/5ML SOLUTION / ORAL RLD, RS 2019-01-30 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N210942-001 GLOPERBA 0.6MG/5ML SOLUTION / ORAL RLD, RS 2019-01-30 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N210942-001 GLOPERBA 0.6MG/5ML SOLUTION / ORAL RLD, RS 2019-01-30 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N210942-001 GLOPERBA 0.6MG/5ML SOLUTION / ORAL RLD, RS 2019-01-30 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N210942-001 GLOPERBA 0.6MG/5ML SOLUTION / ORAL RLD, RS 2019-01-30 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N210942-001 GLOPERBA 0.6MG/5ML SOLUTION / ORAL RLD, RS 2019-01-30 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N210942-001 GLOPERBA 0.6MG/5ML SOLUTION / ORAL RLD, RS 2019-01-30 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N210942-001 GLOPERBA 0.6MG/5ML SOLUTION / ORAL RLD, RS 2019-01-30 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N210942-001 GLOPERBA 0.6MG/5ML SOLUTION / ORAL RLD, RS 2019-01-30 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N210942-001 GLOPERBA 0.6MG/5ML SOLUTION / ORAL RLD, RS 2019-01-30 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N210942-001 GLOPERBA 0.6MG/5ML SOLUTION / ORAL RLD, RS 2019-01-30 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N210942-001 GLOPERBA 0.6MG/5ML SOLUTION / ORAL RLD, RS 2019-01-30 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N210942-001 GLOPERBA 0.6MG/5ML SOLUTION / ORAL RLD, RS 2019-01-30 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N210942-001 GLOPERBA 0.6MG/5ML SOLUTION / ORAL RLD, RS 2019-01-30 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N210942-001 GLOPERBA 0.6MG/5ML SOLUTION / ORAL RLD, RS 2019-01-30 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N210942-001 GLOPERBA 0.6MG/5ML SOLUTION / ORAL RLD, RS 2019-01-30 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N210942-001 GLOPERBA 0.6MG/5ML SOLUTION / ORAL RLD, RS 2019-01-30 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N210942-001 GLOPERBA 0.6MG/5ML SOLUTION / ORAL RLD, RS 2019-01-30 cb3db0bc1861…
Observed Orange Book patent history# Patent history page 1 of 5 · 162 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N210942-001 10383820 2036-11-22 U-2814 Drug product 2019-08-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210942-001 10383821 2036-11-22 Drug product 2019-08-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210942-001 12274751 2036-11-22 U-2814 2025-04-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210942-001 12514819 2036-11-22 U-2814 2026-02-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210942-001 9907751 2036-11-22 Drug product 2019-02-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210942-001 10226423 2037-12-20 Drug product 2019-03-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210942-001 10383820 2036-11-22 U-2814 Drug product 2019-08-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210942-001 10383821 2036-11-22 Drug product 2019-08-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210942-001 12274751 2036-11-22 U-2814 2025-04-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210942-001 9907751 2036-11-22 Drug product 2019-02-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210942-001 10226423 2037-12-20 Drug product 2019-03-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N210942-001 10383820 2036-11-22 U-2814 Drug product 2019-08-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N210942-001 10383821 2036-11-22 Drug product 2019-08-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N210942-001 12274751 2036-11-22 U-2814 2025-04-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N210942-001 9907751 2036-11-22 Drug product 2019-02-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N210942-001 10226423 2037-12-20 Drug product 2019-03-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210942-001 10383820 2036-11-22 U-2814 Drug product 2019-08-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210942-001 10383821 2036-11-22 Drug product 2019-08-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210942-001 9907751 2036-11-22 Drug product 2019-02-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210942-001 10226423 2037-12-20 Drug product 2019-03-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N210942-001 10383820 2036-11-22 U-2814 Drug product 2019-08-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N210942-001 10383821 2036-11-22 Drug product 2019-08-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N210942-001 9907751 2036-11-22 Drug product 2019-02-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N210942-001 10226423 2037-12-20 Drug product 2019-03-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N210942-001 10383820 2036-11-22 U-2814 Drug product 2019-08-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N210942-001 10383821 2036-11-22 Drug product 2019-08-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N210942-001 9907751 2036-11-22 Drug product 2019-02-26 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N210942-001 10226423 2037-12-20 Drug product 2019-03-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N210942-001 10383820 2036-11-22 U-2814 Drug product 2019-08-28 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N210942-001 10383821 2036-11-22 Drug product 2019-08-28 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N210942-001 9907751 2036-11-22 Drug product 2019-02-26 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N210942-001 10226423 2037-12-20 Drug product 2019-03-27 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N210942-001 10383820 2036-11-22 U-2814 Drug product 2019-08-28 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N210942-001 10383821 2036-11-22 Drug product 2019-08-28 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N210942-001 9907751 2036-11-22 Drug product 2019-02-26 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N210942-001 10226423 2037-12-20 Drug product 2019-03-27 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N210942-001 10383820 2036-11-22 U-2814 Drug product 2019-08-28 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N210942-001 10383821 2036-11-22 Drug product 2019-08-28 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N210942-001 9907751 2036-11-22 Drug product 2019-02-26 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N210942-001 10226423 2037-12-20 Drug product 2019-03-27 d8e5a09893c0…
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 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Gloperba COLCHICINE Scilex Pharmaceuticals Inc. 467cd83f-d695-4040-9434-10e80b4271da 2024-11-01 Warnings, Adverse reactions Exact identifier application applno (NDA): 210942 application number: NDA210942
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 75854-801-01 75854080101 150 mL in 1 BOTTLE, PLASTIC (75854-801-01) 150 ml 2019-08-01 0000-00-00 No No Current