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

Additional Listing Data#

Finished product
Yes
Brand name base
CLENPIQ
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ANHYDROUS CITRIC ACID12 g/175mL
MAGNESIUM OXIDE3.5 g/175mL
SODIUM PICOSULFATE10 mg/175mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiXF417D3PSL, 3A3U0GI71G, LR57574HN8
Rxcui2626364, 2626366

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6e3c022f-0786-43f1-8857-edff89d5153fProduct name120260309
95250459-30e4-45c1-b08a-993044f49109Product name220250805
efd58652-cb8f-4018-91ca-4b0eb2ff729fProduct name720240226
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
2641ccb3-721d-4fbf-9f2f-ca2f18157a62Product name320210309
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
26acd337-b838-40ac-bcbc-05c3b81c8712Product name120170323
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
e7e58cd3-cacb-49df-8d34-1ee335614abbProduct name120150609
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55566-6800-0CLENPIQ175 mL in 1 BOTTLELIQUID1756
55566-6800-1CLENPIQ2 in 1 CARTONLIQUID26
55566-6800-2CLENPIQ2 in 1 CARTONLIQUID26

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55566-6800-0ML - Milliliter55566-68007d0a8189-54e6-4145-a21e-6ef900a8aedd12023-03-13
55566-6800-1ML - Milliliter55566-680026197c59-8754-4235-84d4-87de51461cea12023-03-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55566-6800CLENPIQ (SODIUM PICOSULFATE, MAGNESIUM OXIDE, AND ANHYDROUS CITRIC ACID) LIQUID [FERRING PHARMACEUTICALS INC.]4Current NDC, Legacy NDC, 3 package rows20250409_e95fff66-4ec0-4001-a727-33e66a5ec7d5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2626364citric acid 12 GM / magnesium oxide 3.5 GM / picosulfate sodium 10 MG in 175 mL Oral SolutionPSNe95fff66-4ec0-4001-a727-33e66a5ec7d56
2626366CLENPIQ 10 MG / 3.5 GM / 12 GM in 175 mL Oral SolutionPSNe95fff66-4ec0-4001-a727-33e66a5ec7d56
2626366citric acid 68.6 MG/ML / magnesium oxide 20 MG/ML / picosulfate sodium 0.0571 MG/ML Oral Solution [Clenpiq]SBDe95fff66-4ec0-4001-a727-33e66a5ec7d56
2626364citric acid 68.6 MG/ML / magnesium oxide 20 MG/ML / picosulfate sodium 0.0571 MG/ML Oral SolutionSCDe95fff66-4ec0-4001-a727-33e66a5ec7d56
2626364citric acid 12 GM / magnesium oxide 3.5 GM / picosulfate sodium 10 MG per 175 ML Oral SolutionSYe95fff66-4ec0-4001-a727-33e66a5ec7d56
2626366CLENPIQ (citric acid 12 GM / magnesium oxide 3.5 GM / picosulfate sodium 10 MG) per 175 ML Oral SolutionSYe95fff66-4ec0-4001-a727-33e66a5ec7d56

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55566-6800-055566680000175 mL in 1 BOTTLE175 mlHistorical
55566-6800-1555666800012 BOTTLE in 1 CARTON (55566-6800-1) / 175 mL in 1 BOTTLE (55566-6800-0) 2 bottle2023-03-290000-00-00NoNoCurrent
55566-6800-2555666800022 BOTTLE in 1 CARTON (55566-6800-2) / 175 mL in 1 BOTTLE (55566-6800-0) 2 bottle2023-03-30YesNoHistorical