CLENPIQ

Product NDC
72032-6700
11-digit product format
720326700
Labeler code
72032
Product ID
72032-6700_4281e5a9-1b98-4e2a-9a85-f6e6d6e63763
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
SODIUM PICOSULFATE, MAGNESIUM OXIDE, and ANHYDROUS CITRIC ACID
Dosage form
LIQUID
Route
ORAL
Labeler
ASM Aerosol-Service AG
Application
NDA209589
Marketing category
NDA
Marketing start
2017-11-28
Marketing end
0000-00-00
Substance
SODIUM PICOSULFATE; MAGNESIUM OXIDE; ANHYDROUS CITRIC ACID
Active strength
10 mg/160mL; g/160mL; g/160mL
Pharmacologic classes
Increased Large Intestinal Motility [PE],Stimulant Laxative [EPC],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA]
NDC exclude flag
No
Listing certified through
2021-12-31
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.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct72032-6700DDiscontinued by firm2026-08-17
excluded packagepackage72032-670072032-6700-1DDiscontinued by firm2026-08-17

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 · 24 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage72032-6700-1d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage72032-6700-1f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage72032-6700-12ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage72032-6700-1a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage72032-6700-1cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage72032-6700-1cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage72032-6700-1302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage72032-6700-1ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage72032-6700-10efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage72032-6700-1ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage72032-6700-1367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage72032-6700-1557ba5c1ecfa…9c80585c8c6e…

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N209589-001CLENPIQCITRIC ACID; MAGNESIUM OXIDE; SODIUM PICOSULFATE12GM/BOT;3.5GM/BOT;10MG/BOTSOLUTION / ORALRLD, RS2017-11-28

Orange Book patents#

Current patent rows page 1 of 1 · 5 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N209589-001106248792034-06-23Drug product2020-05-04
N209589-001111917532034-06-23U-32612021-12-21
N209589-001125760722034-06-23U-3261Drug product2026-04-14
N209589-00198272312034-06-26U-2162Drug product2017-12-06
N209589-001124586342038-01-27Drug product2025-11-07

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07N209589-001CLENPIQ12GM/BOT;3.5GM/BOT;10MG/BOTSOLUTION / ORALRLD, RS2017-11-28caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N209589-001CLENPIQ12GM/BOT;3.5GM/BOT;10MG/BOTSOLUTION / ORALRLD, RS2017-11-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N209589-001CLENPIQ12GM/BOT;3.5GM/BOT;10MG/BOTSOLUTION / ORALRLD, RS2017-11-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08N209589-001CLENPIQ12GM/BOT;3.5GM/BOT;10MG/BOTSOLUTION / ORALRLD, RS2017-11-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N209589-001CLENPIQ12GM/BOT;3.5GM/BOT;10MG/BOTSOLUTION / ORALRLD, RS2017-11-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N209589-001CLENPIQ12GM/BOT;3.5GM/BOT;10MG/BOTSOLUTION / ORALRLD, RS2017-11-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N209589-001CLENPIQ12GM/BOT;3.5GM/BOT;10MG/BOTSOLUTION / ORALRLD, RS2017-11-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N209589-001CLENPIQ12GM/BOT;3.5GM/BOT;10MG/BOTSOLUTION / ORALRLD, RS2017-11-282680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N209589-001CLENPIQ12GM/BOT;3.5GM/BOT;10MG/BOTSOLUTION / ORALRLD, RS2017-11-285bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N209589-001CLENPIQ12GM/BOT;3.5GM/BOT;10MG/BOTSOLUTION / ORALRLD, RS2017-11-28d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N209589-001CLENPIQ12GM/BOT;3.5GM/BOT;10MG/BOTSOLUTION / ORALRLD, RS2017-11-28d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N209589-001CLENPIQ12GM/BOT;3.5GM/BOT;10MG/BOTSOLUTION / ORALRLD, RS2017-11-2879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N209589-001CLENPIQ12GM/BOT;3.5GM/BOT;10MG/BOTSOLUTION / ORALRLD, RS2017-11-28301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N209589-001CLENPIQ12GM/BOT;3.5GM/BOT;10MG/BOTSOLUTION / ORALRLD, RS2017-11-281e350fbaab3a…
2024-05-31 18:47 UTC2024-05N209589-001CLENPIQ12GM/BOT;3.5GM/BOT;10MG/BOTSOLUTION / ORALRLD, RS2017-11-288072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N209589-001CLENPIQ12GM/BOT;3.5GM/BOT;10MG/BOTSOLUTION / ORALRLD, RS2017-11-285c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N209589-001CLENPIQ12GM/BOT;3.5GM/BOT;10MG/BOTSOLUTION / ORALRLD, RS2017-11-285d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N209589-001CLENPIQ12GM/BOT;3.5GM/BOT;10MG/BOTSOLUTION / ORALRLD, RS2017-11-284b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N209589-001CLENPIQ12GM/BOT;3.5GM/BOT;10MG/BOTSOLUTION / ORALRLD, RS2017-11-2874a2ff9319b5…
2022-03-09 01:35 UTC2022-03N209589-001CLENPIQ12GM/BOT;3.5GM/BOT;10MG/BOTSOLUTION / ORALRLD, RS2017-11-28bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N209589-001CLENPIQ12GM/BOT;3.5GM/BOT;10MG/BOTSOLUTION / ORALRLD, RS2017-11-28782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N209589-001CLENPIQ12GM/BOT;3.5GM/BOT;10MG/BOTSOLUTION / ORALRLD, RS2017-11-2887673890dc5c…
2021-03-12 10:30 UTC2021-03N209589-001CLENPIQ12GM/BOT;3.5GM/BOT;10MG/BOTSOLUTION / ORALRLD, RS2017-11-285aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N209589-001CLENPIQ12GM/BOT;3.5GM/BOT;10MG/BOTSOLUTION / ORALRLD, RS2017-11-288869cabd3fbd…
2020-11-12 02:37 UTC2020-11N209589-001CLENPIQ12GM/BOT;3.5GM/BOT;10MG/BOTSOLUTION / ORALRLD, RS2017-11-28c0c555d07b60…
2019-12-14 00:12 UTC2019-12N209589-001CLENPIQ12GM/BOT;3.5GM/BOT;10MG/BOTSOLUTION / ORALRLD, RS2017-11-283f01610625f2…
2019-09-15 20:21 UTC2019-09N209589-001CLENPIQ12GM/BOT;3.5GM/BOT;10MG/BOTSOLUTION / ORALRLD, RS2017-11-28b00525d2431f…
2019-07-19 19:46 UTC2019-07N209589-001CLENPIQ12GM/BOT;3.5GM/BOT;10MG/BOTSOLUTION / ORALRLD, RS2017-11-28ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N209589-001CLENPIQ12GM/BOT;3.5GM/BOT;10MG/BOTSOLUTION / ORALRLD, RS2017-11-286a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N209589-001CLENPIQ12GM/BOT;3.5GM/BOT;10MG/BOTSOLUTION / ORALRLD, RS2017-11-281c564ffb4f44…
2023-12-20 04:57 UTC2023-12N209589-001CLENPIQ12GM/BOT;3.5GM/BOT;10MG/BOTSOLUTION / ORALRLD, RS2017-11-28ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N209589-001CLENPIQ12GM/BOT;3.5GM/BOT;10MG/BOTSOLUTION / ORALRLD, RS2017-11-28a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N209589-001CLENPIQ12GM/BOT;3.5GM/BOT;10MG/BOTSOLUTION / ORALRLD, RS2017-11-289b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N209589-001CLENPIQ12GM/BOT;3.5GM/BOT;10MG/BOTSOLUTION / ORALRLD, RS2017-11-28a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N209589-001CLENPIQ12GM/BOT;3.5GM/BOT;10MG/BOTSOLUTION / ORALRLD, RS2017-11-283f0d92c62455…
2023-05-13 08:27 UTC2023-05N209589-001CLENPIQ12GM/BOT;3.5GM/BOT;10MG/BOTSOLUTION / ORALRLD, RS2017-11-28053a50430f4f…
2023-01-26 05:58 UTC2023-01N209589-001CLENPIQ12GM/BOT;3.5GM/BOT;10MG/BOTSOLUTION / ORALRLD, RS2017-11-283bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N209589-001CLENPIQ12GM/BOT;3.5GM/BOT;10MG/BOTSOLUTION / ORALRLD, RS2017-11-283a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N209589-001CLENPIQ12GM/BOT;3.5GM/BOT;10MG/BOTSOLUTION / ORALRLD, RS2017-11-28f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N209589-001CLENPIQ12GM/BOT;3.5GM/BOT;10MG/BOTSOLUTION / ORALRLD, RS2017-11-28e64feba35796…

Observed Orange Book patent history#

Patent history page 1 of 3 · 119 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-08-18 06:07:402026-07N209589-001106248792034-06-23Drug product2020-05-04caaa826d4ba7…
2026-08-18 06:07:402026-07N209589-001111917532034-06-23U-32612021-12-21caaa826d4ba7…
2026-08-18 06:07:402026-07N209589-001125760722034-06-23U-3261Drug product2026-04-14caaa826d4ba7…
2026-08-18 06:07:402026-07N209589-00198272312034-06-26U-2162Drug product2017-12-06caaa826d4ba7…
2026-08-18 06:07:402026-07N209589-001124586342038-01-27Drug product2025-11-07caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N209589-001106248792034-06-23Drug product2020-05-04011fe1cb6892…
2026-02-19 14:30 UTC2026-02N209589-001111917532034-06-23U-32612021-12-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02N209589-00198272312034-06-26U-2162Drug product2017-12-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02N209589-001124586342038-01-27Drug product2025-11-07011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N209589-001106248792034-06-23Drug product2020-05-0431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N209589-001111917532034-06-23U-32612021-12-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N209589-00198272312034-06-26U-2162Drug product2017-12-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N209589-001124586342038-01-27Drug product2025-11-0731067a03dcf5…
2025-08-23 18:47 UTC2025-08N209589-001106248792034-06-23Drug product2020-05-046a471c1ec25d…
2025-08-23 18:47 UTC2025-08N209589-001111917532034-06-23U-32612021-12-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08N209589-00198272312034-06-26U-2162Drug product2017-12-066a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N209589-001106248792034-06-23Drug product2020-05-04fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N209589-001111917532034-06-23U-32612021-12-21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N209589-00198272312034-06-26U-2162Drug product2017-12-06fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N209589-001106248792034-06-23Drug product2020-05-04b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N209589-001111917532034-06-23U-32612021-12-21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N209589-00198272312034-06-26U-2162Drug product2017-12-06b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N209589-001106248792034-06-23Drug product2020-05-0403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N209589-001111917532034-06-23U-32612021-12-2103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N209589-00198272312034-06-26U-2162Drug product2017-12-0603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N209589-001106248792034-06-23Drug product2020-05-042680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N209589-001111917532034-06-23U-32612021-12-212680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N209589-00198272312034-06-26U-2162Drug product2017-12-062680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N209589-001106248792034-06-23Drug product2020-05-045bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N209589-001111917532034-06-23U-32612021-12-215bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N209589-00198272312034-06-26U-2162Drug product2017-12-065bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N209589-001106248792034-06-23Drug product2020-05-04d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N209589-001111917532034-06-23U-32612021-12-21d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N209589-00198272312034-06-26U-2162Drug product2017-12-06d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N209589-001106248792034-06-23Drug product2020-05-04d06236e962d9…
2024-10-29 15:01 UTC2024-10N209589-001111917532034-06-23U-32612021-12-21d06236e962d9…
2024-10-29 15:01 UTC2024-10N209589-00198272312034-06-26U-2162Drug product2017-12-06d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N209589-001106248792034-06-23Drug product2020-05-0479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N209589-001111917532034-06-23U-32612021-12-2179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N209589-00198272312034-06-26U-2162Drug product2017-12-0679d66fd596c7…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2021-12-28 21:50 UTC2021-12N209589-001NPP2021-08-15782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N209589-001NPP2021-08-1587673890dc5c…

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CLENPIQSODIUM PICOSULFATE, MAGNESIUM OXIDE, AND ANHYDROUS CITRIC ACIDFerring Pharmaceuticals Inc.e95fff66-4ec0-4001-a727-33e66a5ec7d52026-04-15Warnings, Adverse reactionsExact identifier
application applno (NDA): 209589
application number: NDA209589