FDA.reportPublic FDA data

SODIUM SULFATE, POTASSIUM SULFATE, MAGNESIUM SULFATE

Product NDC
43386-700
11-digit product format
433860700
Labeler code
43386
Product ID
43386-700_9fffaef0-0578-452d-a365-166b183d8e00
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
sodium sulfate, potassium sulfate, magnesium sulfate
Dosage form
SOLUTION
Route
ORAL
Labeler
Lupin Pharmaceuticals, Inc.
Application
ANDA202511
Marketing category
ANDA
Marketing start
2022-12-30
Substance
MAGNESIUM SULFATE ANHYDROUS; POTASSIUM SULFATE; SODIUM SULFATE
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
SODIUM SULFATE, POTASSIUM SULFATE, MAGNESIUM SULFATE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MAGNESIUM SULFATE ANHYDROUS1.6 g/177mL
POTASSIUM SULFATE3.13 g/177mL
SODIUM SULFATE17.5 g/177mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiML30MJ2U7I, 1K573LC5TV, 0YPR65R21J
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
43386-700-83SODIUM SULFATE, POTASSIUM SULFATE, MAGNESIUM SULFATE177 mL in 1 BOTTLESOLUTION1774
43386-700-83SODIUM SULFATE, POTASSIUM SULFATE, MAGNESIUM SULFATE2 in 1 CARTONSOLUTION24

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43386-700-02ML - Milliliter43386-700fee5b452-2276-4771-91de-bcf3d37381c512024-01-04
43386-700-83ML - Milliliter43386-70064ba38f9-e11d-4bce-8a21-9d4fdefd274012023-02-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43386-700SODIUM SULFATE, POTASSIUM SULFATE, MAGNESIUM SULFATE SOLUTION [LUPIN PHARMACEUTICALS, INC.]3Current NDC, Legacy NDC, 2 package rows20231221_d4883657-d27d-4056-a567-5fb12d5e05d1.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) } PackGPCKd4883657-d27d-4056-a567-5fb12d5e05d14
10016892 (16 OZ magnesium sulfate 1.6 GM / potassium sulfate 3.13 GM / sodium sulfate 17.5 GM Oral Solution) PackPSNd4883657-d27d-4056-a567-5fb12d5e05d14
1120068magnesium sulfate 1.6 GM / potassium sulfate 3.13 GM / sodium sulfate 17.5 GM in 177 mL Oral SolutionPSNd4883657-d27d-4056-a567-5fb12d5e05d14
1120068magnesium sulfate 0.0277 MEQ/ML / potassium sulfate 0.0374 MEQ/ML / sodium sulfate 0.257 MEQ/ML Oral SolutionSCDd4883657-d27d-4056-a567-5fb12d5e05d14
1120068Magnesium Sulfate 0.0277 MEQ/ML / K+ sulfate 0.0374 MEQ/ML / sodium sulfate 0.257 MEQ/ML Oral SolutionSYd4883657-d27d-4056-a567-5fb12d5e05d14
1120068Magnesium Sulfate 0.0277 MEQ/ML / Pot sulfate 0.0374 MEQ/ML / sodium sulfate 0.257 MEQ/ML Oral SolutionSYd4883657-d27d-4056-a567-5fb12d5e05d14
1120068magnesium sulfate 1.6 GM / potassium sulfate 3.13 GM / sodium sulfate 17.5 GM per 177 ML Oral SolutionSYd4883657-d27d-4056-a567-5fb12d5e05d14

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43386-700-83433860700832 BOTTLE in 1 CARTON (43386-700-83) / 177 mL in 1 BOTTLE2 bottle2022-12-300000-00-00NoNoCurrent