FDA.reportPublic FDA data

Sodium Sulfate, Potassium Sulfate, and Magnesium Sulfate Bowel Prep kit

Product NDC
51672-4170
11-digit product format
516724170
Labeler code
51672
Product ID
51672-4170_494f52da-8ae6-6ec4-e063-6294a90a73a6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
sodium sulfate anhydrous, potassium sulfate, and magnesium sulfate
Dosage form
SOLUTION
Route
ORAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA206431
Marketing category
ANDA
Marketing start
2024-03-27
Substance
MAGNESIUM SULFATE, UNSPECIFIED FORM; POTASSIUM SULFATE; SODIUM SULFATE ANHYDROUS
Active strength
1.6; 3.13; 17.5 g/177mL; g/177mL; g/177mL
Pharmacologic classes
Calculi Dissolution Agent [EPC], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], 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
Sodium Sulfate, Potassium Sulfate, and Magnesium Sulfate Bowel Prep kit
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MAGNESIUM SULFATE, UNSPECIFIED FORM1.6 g/177mL
POTASSIUM SULFATE3.13 g/177mL
SODIUM SULFATE ANHYDROUS17.5 g/177mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiDE08037SAB, 1K573LC5TV, 36KCS0R750
Rxcui1001689, 1120068

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
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
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
51672-4170-5Sodium Sulfate, Potassium Sulfate, and Magnesium Sulfate Bowel Prep kit2 in 1 CARTONSOLUTION210
51672-4170-5Sodium Sulfate, Potassium Sulfate, and Magnesium Sulfate Bowel Prep kit177 mL in 1 BOTTLESOLUTION17710

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51672-4170-5ML - Milliliter51672-4170089930b7-eef0-42d2-8fc6-043d5d156d6e12024-06-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51672-4170SODIUM SULFATE, POTASSIUM SULFATE, AND MAGNESIUM SULFATE BOWEL PREP KIT (SODIUM SULFATE ANHYDROUS, POTASSIUM SULFATE, AND MAGNESIUM SULFATE) SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.]6Current NDC, 2 package rows20241006_4adeeb11-0f3a-47d8-a664-376df50b05f2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1001689{2 (480 ML) (magnesium sulfate 0.0277 MEQ/ML / potassium sulfate 0.0374 MEQ/ML / sodium sulfate 0.257 MEQ/ML Oral Solution) } PackGPCK4adeeb11-0f3a-47d8-a664-376df50b05f210
10016892 (16 OZ magnesium sulfate 1.6 GM / potassium sulfate 3.13 GM / sodium sulfate 17.5 GM Oral Solution) PackPSN4adeeb11-0f3a-47d8-a664-376df50b05f210
1120068magnesium sulfate 1.6 GM / potassium sulfate 3.13 GM / sodium sulfate 17.5 GM in 177 mL Oral SolutionPSN4adeeb11-0f3a-47d8-a664-376df50b05f210
1120068magnesium sulfate 0.0277 MEQ/ML / potassium sulfate 0.0374 MEQ/ML / sodium sulfate 0.257 MEQ/ML Oral SolutionSCD4adeeb11-0f3a-47d8-a664-376df50b05f210
1120068Magnesium Sulfate 0.0277 MEQ/ML / K+ sulfate 0.0374 MEQ/ML / sodium sulfate 0.257 MEQ/ML Oral SolutionSY4adeeb11-0f3a-47d8-a664-376df50b05f210
1120068Magnesium Sulfate 0.0277 MEQ/ML / Pot sulfate 0.0374 MEQ/ML / sodium sulfate 0.257 MEQ/ML Oral SolutionSY4adeeb11-0f3a-47d8-a664-376df50b05f210
1120068magnesium sulfate 1.6 GM / potassium sulfate 3.13 GM / sodium sulfate 17.5 GM per 177 ML Oral SolutionSY4adeeb11-0f3a-47d8-a664-376df50b05f210

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
51672-4170-5516724170052 BOTTLE in 1 CARTON (51672-4170-5) / 177 mL in 1 BOTTLE2 bottle2024-03-27NoNoCurrent