Home NDC 55566-6800 CLENPIQ
Product NDC 55566-6800
11-digit product format 555666800
Labeler code 55566
Product ID 55566-6800_aa0cda22-b2c4-4612-abc8-8c91bf421c93
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name SODIUM PICOSULFATE, MAGNESIUM OXIDE, and ANHYDROUS CITRIC ACID
Dosage form LIQUID
Route ORAL
Labeler Ferring Pharmaceuticals Inc.
Application NDA209589
Marketing category NDA
Marketing start 2023-03-29
Substance ANHYDROUS CITRIC ACID; MAGNESIUM OXIDE; SODIUM PICOSULFATE
Active strength 12; 3.5; 10 g/175mL; g/175mL; mg/175mL
Pharmacologic classes Acidifying Activity [MoA], Anti-coagulant [EPC], Calcium Chelating Activity [MoA], Calculi Dissolution Agent [EPC], Calculi Dissolution Agent [EPC], Decreased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulant Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]
NDC exclude flag No
Listing certified through 2027-12-31
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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N209589-001 CLENPIQ CITRIC ACID; MAGNESIUM OXIDE; SODIUM PICOSULFATE 12GM/BOT;3.5GM/BOT;10MG/BOT SOLUTION / ORAL RLD, RS 2017-11-28
Orange Book patents# Current patent rows page 1 of 1 · 5 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N209589-001 10624879 2034-06-23 Drug product 2020-05-04 N209589-001 11191753 2034-06-23 U-3261 2021-12-21 N209589-001 12576072 2034-06-23 U-3261 Drug product 2026-04-14 N209589-001 9827231 2034-06-26 U-2162 Drug product 2017-12-06 N209589-001 12458634 2038-01-27 Drug product 2025-11-07
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 · 42 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 N209589-001 CLENPIQ 12GM/BOT;3.5GM/BOT;10MG/BOT SOLUTION / ORAL RLD, RS 2017-11-28 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N209589-001 CLENPIQ 12GM/BOT;3.5GM/BOT;10MG/BOT SOLUTION / ORAL RLD, RS 2017-11-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209589-001 CLENPIQ 12GM/BOT;3.5GM/BOT;10MG/BOT SOLUTION / ORAL RLD, RS 2017-11-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N209589-001 CLENPIQ 12GM/BOT;3.5GM/BOT;10MG/BOT SOLUTION / ORAL RLD, RS 2017-11-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N209589-001 CLENPIQ 12GM/BOT;3.5GM/BOT;10MG/BOT SOLUTION / ORAL RLD, RS 2017-11-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N209589-001 CLENPIQ 12GM/BOT;3.5GM/BOT;10MG/BOT SOLUTION / ORAL RLD, RS 2017-11-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N209589-001 CLENPIQ 12GM/BOT;3.5GM/BOT;10MG/BOT SOLUTION / ORAL RLD, RS 2017-11-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N209589-001 CLENPIQ 12GM/BOT;3.5GM/BOT;10MG/BOT SOLUTION / ORAL RLD, RS 2017-11-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N209589-001 CLENPIQ 12GM/BOT;3.5GM/BOT;10MG/BOT SOLUTION / ORAL RLD, RS 2017-11-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N209589-001 CLENPIQ 12GM/BOT;3.5GM/BOT;10MG/BOT SOLUTION / ORAL RLD, RS 2017-11-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N209589-001 CLENPIQ 12GM/BOT;3.5GM/BOT;10MG/BOT SOLUTION / ORAL RLD, RS 2017-11-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N209589-001 CLENPIQ 12GM/BOT;3.5GM/BOT;10MG/BOT SOLUTION / ORAL RLD, RS 2017-11-28 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N209589-001 CLENPIQ 12GM/BOT;3.5GM/BOT;10MG/BOT SOLUTION / ORAL RLD, RS 2017-11-28 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N209589-001 CLENPIQ 12GM/BOT;3.5GM/BOT;10MG/BOT SOLUTION / ORAL RLD, RS 2017-11-28 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N209589-001 CLENPIQ 12GM/BOT;3.5GM/BOT;10MG/BOT SOLUTION / ORAL RLD, RS 2017-11-28 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N209589-001 CLENPIQ 12GM/BOT;3.5GM/BOT;10MG/BOT SOLUTION / ORAL RLD, RS 2017-11-28 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N209589-001 CLENPIQ 12GM/BOT;3.5GM/BOT;10MG/BOT SOLUTION / ORAL RLD, RS 2017-11-28 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N209589-001 CLENPIQ 12GM/BOT;3.5GM/BOT;10MG/BOT SOLUTION / ORAL RLD, RS 2017-11-28 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N209589-001 CLENPIQ 12GM/BOT;3.5GM/BOT;10MG/BOT SOLUTION / ORAL RLD, RS 2017-11-28 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N209589-001 CLENPIQ 12GM/BOT;3.5GM/BOT;10MG/BOT SOLUTION / ORAL RLD, RS 2017-11-28 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N209589-001 CLENPIQ 12GM/BOT;3.5GM/BOT;10MG/BOT SOLUTION / ORAL RLD, RS 2017-11-28 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N209589-001 CLENPIQ 12GM/BOT;3.5GM/BOT;10MG/BOT SOLUTION / ORAL RLD, RS 2017-11-28 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N209589-001 CLENPIQ 12GM/BOT;3.5GM/BOT;10MG/BOT SOLUTION / ORAL RLD, RS 2017-11-28 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N209589-001 CLENPIQ 12GM/BOT;3.5GM/BOT;10MG/BOT SOLUTION / ORAL RLD, RS 2017-11-28 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N209589-001 CLENPIQ 12GM/BOT;3.5GM/BOT;10MG/BOT SOLUTION / ORAL RLD, RS 2017-11-28 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N209589-001 CLENPIQ 12GM/BOT;3.5GM/BOT;10MG/BOT SOLUTION / ORAL RLD, RS 2017-11-28 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N209589-001 CLENPIQ 12GM/BOT;3.5GM/BOT;10MG/BOT SOLUTION / ORAL RLD, RS 2017-11-28 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N209589-001 CLENPIQ 12GM/BOT;3.5GM/BOT;10MG/BOT SOLUTION / ORAL RLD, RS 2017-11-28 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N209589-001 CLENPIQ 12GM/BOT;3.5GM/BOT;10MG/BOT SOLUTION / ORAL RLD, RS 2017-11-28 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N209589-001 CLENPIQ 12GM/BOT;3.5GM/BOT;10MG/BOT SOLUTION / ORAL RLD, RS 2017-11-28 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N209589-001 CLENPIQ 12GM/BOT;3.5GM/BOT;10MG/BOT SOLUTION / ORAL RLD, RS 2017-11-28 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N209589-001 CLENPIQ 12GM/BOT;3.5GM/BOT;10MG/BOT SOLUTION / ORAL RLD, RS 2017-11-28 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N209589-001 CLENPIQ 12GM/BOT;3.5GM/BOT;10MG/BOT SOLUTION / ORAL RLD, RS 2017-11-28 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N209589-001 CLENPIQ 12GM/BOT;3.5GM/BOT;10MG/BOT SOLUTION / ORAL RLD, RS 2017-11-28 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N209589-001 CLENPIQ 12GM/BOT;3.5GM/BOT;10MG/BOT SOLUTION / ORAL RLD, RS 2017-11-28 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N209589-001 CLENPIQ 12GM/BOT;3.5GM/BOT;10MG/BOT SOLUTION / ORAL RLD, RS 2017-11-28 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N209589-001 CLENPIQ 12GM/BOT;3.5GM/BOT;10MG/BOT SOLUTION / ORAL RLD, RS 2017-11-28 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N209589-001 CLENPIQ 12GM/BOT;3.5GM/BOT;10MG/BOT SOLUTION / ORAL RLD, RS 2017-11-28 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N209589-001 CLENPIQ 12GM/BOT;3.5GM/BOT;10MG/BOT SOLUTION / ORAL RLD, RS 2017-11-28 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N209589-001 CLENPIQ 12GM/BOT;3.5GM/BOT;10MG/BOT SOLUTION / ORAL RLD, RS 2017-11-28 e64feba35796…
Observed Orange Book patent history# Patent history page 1 of 3 · 119 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-08-18 06:07:40 2026-07 N209589-001 10624879 2034-06-23 Drug product 2020-05-04 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209589-001 11191753 2034-06-23 U-3261 2021-12-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209589-001 12576072 2034-06-23 U-3261 Drug product 2026-04-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209589-001 9827231 2034-06-26 U-2162 Drug product 2017-12-06 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209589-001 12458634 2038-01-27 Drug product 2025-11-07 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N209589-001 10624879 2034-06-23 Drug product 2020-05-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209589-001 11191753 2034-06-23 U-3261 2021-12-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209589-001 9827231 2034-06-26 U-2162 Drug product 2017-12-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209589-001 12458634 2038-01-27 Drug product 2025-11-07 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209589-001 10624879 2034-06-23 Drug product 2020-05-04 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209589-001 11191753 2034-06-23 U-3261 2021-12-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209589-001 9827231 2034-06-26 U-2162 Drug product 2017-12-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209589-001 12458634 2038-01-27 Drug product 2025-11-07 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N209589-001 10624879 2034-06-23 Drug product 2020-05-04 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N209589-001 11191753 2034-06-23 U-3261 2021-12-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N209589-001 9827231 2034-06-26 U-2162 Drug product 2017-12-06 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N209589-001 10624879 2034-06-23 Drug product 2020-05-04 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N209589-001 11191753 2034-06-23 U-3261 2021-12-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N209589-001 9827231 2034-06-26 U-2162 Drug product 2017-12-06 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N209589-001 10624879 2034-06-23 Drug product 2020-05-04 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N209589-001 11191753 2034-06-23 U-3261 2021-12-21 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N209589-001 9827231 2034-06-26 U-2162 Drug product 2017-12-06 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N209589-001 10624879 2034-06-23 Drug product 2020-05-04 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N209589-001 11191753 2034-06-23 U-3261 2021-12-21 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N209589-001 9827231 2034-06-26 U-2162 Drug product 2017-12-06 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N209589-001 10624879 2034-06-23 Drug product 2020-05-04 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N209589-001 11191753 2034-06-23 U-3261 2021-12-21 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N209589-001 9827231 2034-06-26 U-2162 Drug product 2017-12-06 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N209589-001 10624879 2034-06-23 Drug product 2020-05-04 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N209589-001 11191753 2034-06-23 U-3261 2021-12-21 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N209589-001 9827231 2034-06-26 U-2162 Drug product 2017-12-06 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N209589-001 10624879 2034-06-23 Drug product 2020-05-04 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N209589-001 11191753 2034-06-23 U-3261 2021-12-21 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N209589-001 9827231 2034-06-26 U-2162 Drug product 2017-12-06 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N209589-001 10624879 2034-06-23 Drug product 2020-05-04 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N209589-001 11191753 2034-06-23 U-3261 2021-12-21 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N209589-001 9827231 2034-06-26 U-2162 Drug product 2017-12-06 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N209589-001 10624879 2034-06-23 Drug product 2020-05-04 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N209589-001 11191753 2034-06-23 U-3261 2021-12-21 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N209589-001 9827231 2034-06-26 U-2162 Drug product 2017-12-06 79d66fd596c7…
Observed Orange Book exclusivity history# Captured, Edition, Application-product table Captured Edition Application-product Exclusivity code Expiration Source SHA-256 2021-12-28 21:50 UTC 2021-12 N209589-001 NPP 2021-08-15 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N209589-001 NPP 2021-08-15 87673890dc5c…
Additional Listing Data#
Finished product Yes
Brand name base CLENPIQ
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SODIUM PICOSULFATE 12 g/175mL MAGNESIUM OXIDE 3.5 g/175mL ANHYDROUS CITRIC ACID 10 mg/175mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination LR57574HN8 Internal UNII lookup 3A3U0GI71G Internal UNII lookup XF417D3PSL Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2626364 Internal RxNorm lookup 2626366 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 55566-6800-0 CLENPIQ 175 mL in 1 BOTTLE LIQUID 175 6 55566-6800-1 CLENPIQ 2 in 1 CARTON LIQUID 2 6 55566-6800-2 CLENPIQ 2 in 1 CARTON LIQUID 2 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55566-6800 CLENPIQ (SODIUM PICOSULFATE, MAGNESIUM OXIDE, AND ANHYDROUS CITRIC ACID) LIQUID [FERRING PHARMACEUTICALS INC.] 4 Current NDC, Legacy NDC, 3 package rows 20250409_e95fff66-4ec0-4001-a727-33e66a5ec7d5.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 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join CLENPIQ SODIUM PICOSULFATE, MAGNESIUM OXIDE, AND ANHYDROUS CITRIC ACID Ferring Pharmaceuticals Inc. e95fff66-4ec0-4001-a727-33e66a5ec7d5 2026-04-15 Warnings, Adverse reactions Exact identifier application applno (NDA): 209589 application number: NDA209589 ndc (product): 55566-6800
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 55566-6800-0 55566680000 175 mL in 1 BOTTLE 175 ml Historical 55566-6800-1 55566680001 2 BOTTLE in 1 CARTON (55566-6800-1) / 175 mL in 1 BOTTLE (55566-6800-0) 2 bottle 2023-03-29 0000-00-00 No No Current 55566-6800-2 55566680002 2 BOTTLE in 1 CARTON (55566-6800-2) / 175 mL in 1 BOTTLE (55566-6800-0) 2 bottle 2023-03-30 Yes No Current