SODIUM PICOSULFATE, MAGNESIUM OXIDE AND ANHYDROUS CITRIC ACID

Product NDC
31722-874
11-digit product format
317220874
Labeler code
31722
Product ID
31722-874_e5f24116-74a6-1eb8-e053-2a95a90a28cc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
SODIUM PICOSULFATE, MAGNESIUM OXIDE AND ANHYDROUS CITRIC ACID
Dosage form
POWDER, METERED
Route
ORAL
Labeler
Camber Pharmaceuticals, Inc.
Application
ANDA212789
Marketing category
ANDA
Marketing start
2022-07-18
Marketing end
0000-00-00
Substance
ANHYDROUS CITRIC ACID; MAGNESIUM OXIDE; SODIUM PICOSULFATE
Active strength
12 g/16.1g; g/16.1g; mg/16.1g
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
2023-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
31722-874-16SODIUM PICOSULFATE, MAGNESIUM OXIDE AND ANHYDROUS CITRIC ACID16.1 g in 1 PACKETPOWDER, METERED16.11
31722-874-16SODIUM PICOSULFATE, MAGNESIUM OXIDE AND ANHYDROUS CITRIC ACID2 in 1 CARTONPOWDER, METERED21

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
31722-874SODIUM PICOSULFATE, MAGNESIUM OXIDE AND ANHYDROUS CITRIC ACID (SODIUM PICOSULFATE, MAGNESIUM OXIDE AND ANHYDROUS CITRIC ACID) POWDER, METERED [CAMBER PHARMACEUTICALS, INC.]1Legacy NDC, 2 package rows20220812_b759dc12-2dc1-4ef4-a375-1a61630d54d6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1305808sodium picosulfate 10 MG / magnesium oxide 3.5 GM / citric acid 12 GM Powder for Oral SolutionPSNb759dc12-2dc1-4ef4-a375-1a61630d54d61
1305808citric acid 12000 MG / magnesium oxide 3500 MG / picosulfate sodium 10 MG Powder for Oral SolutionSCDb759dc12-2dc1-4ef4-a375-1a61630d54d61
1305808citric acid 12 GM / magnesium oxide 3.5 GM / picosulfate sodium 10 MG Powder for Oral SolutionSYb759dc12-2dc1-4ef4-a375-1a61630d54d61

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
31722-874-16317220874162 PACKET in 1 CARTON (31722-874-16) > 16.1 g in 1 PACKET2 packet2022-07-180000-00-00NoNoCurrent