Home NDC 33342-546 Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate oral
Product NDC 33342-546
11-digit product format 333420546
Labeler code 33342
Product ID 33342-546_e56e8f90-51f5-4f51-9b6b-a6f5a2e499cc
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate oral
Dosage form SOLUTION
Route ORAL
Labeler Macleods Pharmaceuticals Limited
Application ANDA219429
Marketing category ANDA
Marketing start 2026-08-31
Substance SODIUM SULFATE; POTASSIUM SULFATE; MAGNESIUM SULFATE
Active strength 17.5; 3.13; 1.6 g/177mL; g/177mL; g/177mL
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 43 .
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 A219429-001 SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATE MAGNESIUM SULFATE; POTASSIUM SULFATE; SODIUM SULFATE 1.6GM/BOT;3.13GM/BOT;17.5GM/BOT SOLUTION / ORAL AA 2026-08-31
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A219429-001 AA
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 2026-09-14 22:38:34 2026-08 A219429-001 SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATE 1.6GM/BOT;3.13GM/BOT;17.5GM/BOT SOLUTION / ORAL AA 2026-08-31 84e616aacf4f…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-09-14 22:38:34 2026-08 A219429-001 AA 1 84e616aacf4f…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate oral
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SODIUM SULFATE 17.5 g/177mL POTASSIUM SULFATE 3.13 g/177mL MAGNESIUM SULFATE 1.6 g/177mL
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 33342-546-53 33342054653 2 BOTTLE in 1 CARTON (33342-546-53) / 177 mL in 1 BOTTLE (33342-546-23) 2 bottle 2026-08-31 No No Current