Home NDC 69452-428 sodium sulfate, potassium sulfate, and magnesium sulfate
Product NDC 69452-428
11-digit product format 694520428
Labeler code 69452
Product ID 69452-428_557ef7f3-3db5-98bc-e063-6394a90af8ac
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name sodium sulfate, potassium sulfate, and magnesium sulfate
Dosage form SOLUTION
Route ORAL
Labeler Bionpharma Inc.,
Application ANDA204135
Marketing category ANDA
Marketing start 2025-04-15
Substance SODIUM SULFATE; POTASSIUM SULFATE; MAGNESIUM SULFATE ANHYDROUS
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], 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 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 A204135-001 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 2024-06-24
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A204135-001 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 A204135-001 SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATE 1.6GM/BOT;3.13GM/BOT;17.5GM/BOT SOLUTION / ORAL AA 2024-06-24 84e616aacf4f…2026-08-18 06:07:40 2026-07 A204135-001 SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATE 1.6GM/BOT;3.13GM/BOT;17.5GM/BOT SOLUTION / ORAL AA 2024-06-24 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A204135-001 SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATE 1.6GM/BOT;3.13GM/BOT;17.5GM/BOT SOLUTION / ORAL AA 2024-06-24 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204135-001 SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATE 1.6GM/BOT;3.13GM/BOT;17.5GM/BOT SOLUTION / ORAL AA 2024-06-24 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A204135-001 SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATE 1.6GM/BOT;3.13GM/BOT;17.5GM/BOT SOLUTION / ORAL AA 2024-06-24 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204135-001 SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATE 1.6GM/BOT;3.13GM/BOT;17.5GM/BOT SOLUTION / ORAL AA 2024-06-24 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204135-001 SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATE 1.6GM/BOT;3.13GM/BOT;17.5GM/BOT SOLUTION / ORAL AA 2024-06-24 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204135-001 SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATE 1.6GM/BOT;3.13GM/BOT;17.5GM/BOT SOLUTION / ORAL AA 2024-06-24 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204135-001 SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATE 1.6GM/BOT;3.13GM/BOT;17.5GM/BOT SOLUTION / ORAL AA 2024-06-24 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204135-001 SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATE 1.6GM/BOT;3.13GM/BOT;17.5GM/BOT SOLUTION / ORAL AA 2024-06-24 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A204135-001 SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATE 1.6GM/BOT;3.13GM/BOT;17.5GM/BOT SOLUTION / ORAL AA 2024-06-24 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A204135-001 SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATE 1.6GM/BOT;3.13GM/BOT;17.5GM/BOT SOLUTION / ORAL AA 2024-06-24 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A204135-001 SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATE 1.6GM/BOT;3.13GM/BOT;17.5GM/BOT SOLUTION / ORAL AA 2024-06-24 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A204135-001 SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATE 1.6GM/BOT;3.13GM/BOT;17.5GM/BOT SOLUTION / ORAL AA 2024-06-24 301d65b070ca…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A204135-001 SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATE 1.6GM/BOT;3.13GM/BOT;17.5GM/BOT SOLUTION / ORAL AA 2024-06-24 a50c72e98297…
Observed Orange Book normalized TE history# 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
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 ANHYDROUS 1.6 g/177mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 0YPR65R21J Internal UNII lookup 1K573LC5TV Internal UNII lookup ML30MJ2U7I Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1001689 Internal RxNorm lookup 1120068 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 69452-428-62 sodium sulfate, potassium sulfate, and magnesium sulfate 177 mL in 1 BOTTLE, PLASTIC SOLUTION 177 4 69452-428-62 sodium sulfate, potassium sulfate, and magnesium sulfate 2 in 1 KIT SOLUTION 2 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69452-428 SODIUM SULFATE, POTASSIUM SULFATE, AND MAGNESIUM SULFATE SOLUTION [BIONPHARMA INC.,] 1 Current NDC, 2 package rows 20250416_31d13799-0931-7735-e063-6294a90a6d02.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 69452-428-62 69452042862 2 BOTTLE, PLASTIC in 1 KIT (69452-428-62) / 177 mL in 1 BOTTLE, PLASTIC 2025-04-15 No No Current