Home NDC 10572-112-01 SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATE
Product NDC 10572-112
Requested package NDC 10572-112-01
11-digit product format 105720112
Labeler code 10572
Product ID 10572-112_6ea7a63a-4e7e-4e24-a067-968bd91bb317
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name sodium sulfate, potassium sulfate, magnesium sulfate
Dosage form SOLUTION, CONCENTRATE
Route ORAL
Labeler Affordable Pharmaceuticals, LLC
Application NDA022372
Marketing category NDA
Marketing start 2010-08-05
Substance MAGNESIUM SULFATE, UNSPECIFIED FORM; POTASSIUM SULFATE; SODIUM SULFATE
Active strength 1.2; 2.35; 13.13 g/133.1mL; g/133.1mL; g/133.1mL
Pharmacologic classes Calculi Dissolution Agent [EPC], Increased Large Intestinal Motility [PE], 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 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 Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N022372-001 SUPREP BOWEL PREP KIT MAGNESIUM SULFATE; POTASSIUM SULFATE; SODIUM SULFATE 1.6GM/BOT;3.13GM/BOT;17.5GM/BOT SOLUTION / ORAL AA RLD, RS 2010-08-05
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N022372-001 AA
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 1 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N022372-001 ODE-315 2027-08-05
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.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-01 22:54:32 2026-06 N022372-001 SUPREP BOWEL PREP KIT 1.6GM/BOT;3.13GM/BOT;17.5GM/BOT SOLUTION / ORAL AA RLD, RS 2010-08-05 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-08-01 22:54:32 2026-06 N022372-001 AA 1 a50c72e98297…
Observed Orange Book exclusivity history# Captured, Edition, Application-product table Captured Edition Application-product Exclusivity code Expiration Source SHA-256 2026-08-01 22:54:32 2026-06 N022372-001 ODE-315 2027-08-05 a50c72e98297…
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 4 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATE SODIUM SULFATE, POTASSIUM SULFATE, MAGNESIUM SULFATE Wilshire Pharmaceuticals, Inc. f269929e-c2ff-4288-9d3b-7770bcb5a498 2026-04-13 Warnings, Adverse reactions Exact identifier application applno (NDA): 022372 application number: NDA022372 SUPREP Bowel Prep SODIUM SULFATE, POTASSIUM SULFATE, MAGNESIUM SULFATE Azurity Pharmaceuticals, Inc. 50f23abd-6a66-44cb-960e-d43c16a5ae5f 2026-01-31 Warnings, Adverse reactions Exact identifier application applno (NDA): 022372 application number: NDA022372 SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATE SODIUM SULFATE, POTASSIUM SULFATE, MAGNESIUM SULFATE Affordable Pharmaceuticals, LLC f86bdcc8-e643-4160-89ae-01c89bee842d 2025-11-30 Warnings, Adverse reactions Exact identifier application applno (NDA): 022372 application number: NDA022372 ndc (package): 10572-112-01 ndc (product): 10572-112 ndc11 (package): 10572011201 SUPREP Bowel Prep SODIUM SULFATE, POTASSIUM SULFATE, MAGNESIUM SULFATE Braintree Laboratories, Inc. 2f5f06de-ee98-44c0-be7e-9a998d1e5c16 2025-11-30 Warnings, Adverse reactions Exact identifier application applno (NDA): 022372 application number: NDA022372
Additional Listing Data#
Finished product Yes
Brand name base SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATE
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SODIUM SULFATE 1.2 g/133.1mL POTASSIUM SULFATE 2.35 g/133.1mL MAGNESIUM SULFATE, UNSPECIFIED FORM 13.13 g/133.1mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination DE08037SAB Internal UNII lookup 1K573LC5TV Internal UNII lookup 0YPR65R21J Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1001689 Internal RxNorm lookup 1120068 Internal RxNorm lookup 2390767 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 10572-112-01 SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATE 133.1 mL in 1 BOTTLE, PLASTIC SOLUTION, CONCENTRATE 133.1 2 10572-112-01 SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATE 2 in 1 CARTON SOLUTION, CONCENTRATE 2 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 10572-112 SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATE (SODIUM SULFATE, POTASSIUM SULFATE, MAGNESIUM SULFATE) SOLUTION, CONCENTRATE [AFFORDABLE PHARMACEUTICALS, LLC] 1 Current NDC, Legacy NDC, 2 package rows 20220706_f86bdcc8-e643-4160-89ae-01c89bee842d.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 10572-112-01 10572011201 2 BOTTLE, PLASTIC in 1 CARTON (10572-112-01) / 133.1 mL in 1 BOTTLE, PLASTIC 2021-01-05 0000-00-00 No No Current