Home NDC 52268-201-01 SUTAB
Product NDC 52268-201
Requested package NDC 52268-201-01
11-digit product format 522680201
Labeler code 52268
Product ID 52268-201_093f5259-d407-4295-e063-6294a90abb17
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name sodium sulfate, magnesium sulfate, and potassium chloride
Dosage form TABLET
Route ORAL
Labeler Braintree Laboratories, Inc.
Application NDA213135
Marketing category NDA
Marketing start 2020-11-10
Substance MAGNESIUM SULFATE ANHYDROUS; POTASSIUM CHLORIDE; SODIUM SULFATE
Active strength 2.7; 2.25; 17.75 g/1; g/1; g/1
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], Potassium Compounds [CS], Potassium Salt [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]
NDC exclude flag No
Listing certified through 2026-12-31
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 N213135-001 SUTAB MAGNESIUM SULFATE; POTASSIUM CHLORIDE; SODIUM SULFATE 0.225GM;0.188GM;1.479GM TABLET / ORAL AB RLD, RS 2020-11-10
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N213135-001 AB
Orange Book patents# Current patent rows page 1 of 1 · 4 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N213135-001 10143656 2037-08-04 Drug product 2020-11-13 N213135-001 11033498 2037-08-04 U-3164 2021-07-02 N213135-001 11382864 2037-08-04 U-3164 2022-08-04 N213135-001 11638697 2037-08-04 Drug product 2023-05-31
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 2026-02-19 14:30 UTC 2026-02 N213135-001 SUTAB 0.225GM;0.188GM;1.479GM TABLET / ORAL RLD, RS 2020-11-10 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213135-001 SUTAB 0.225GM;0.188GM;1.479GM TABLET / ORAL RLD, RS 2020-11-10 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N213135-001 SUTAB 0.225GM;0.188GM;1.479GM TABLET / ORAL RLD, RS 2020-11-10 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N213135-001 SUTAB 0.225GM;0.188GM;1.479GM TABLET / ORAL RLD, RS 2020-11-10 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N213135-001 SUTAB 0.225GM;0.188GM;1.479GM TABLET / ORAL RLD, RS 2020-11-10 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N213135-001 SUTAB 0.225GM;0.188GM;1.479GM TABLET / ORAL RLD, RS 2020-11-10 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N213135-001 SUTAB 0.225GM;0.188GM;1.479GM TABLET / ORAL RLD, RS 2020-11-10 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N213135-001 SUTAB 0.225GM;0.188GM;1.479GM TABLET / ORAL RLD, RS 2020-11-10 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N213135-001 SUTAB 0.225GM;0.188GM;1.479GM TABLET / ORAL RLD, RS 2020-11-10 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N213135-001 SUTAB 0.225GM;0.188GM;1.479GM TABLET / ORAL RLD, RS 2020-11-10 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N213135-001 SUTAB 0.225GM;0.188GM;1.479GM TABLET / ORAL RLD, RS 2020-11-10 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N213135-001 SUTAB 0.225GM;0.188GM;1.479GM TABLET / ORAL RLD, RS 2020-11-10 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N213135-001 SUTAB 0.225GM;0.188GM;1.479GM TABLET / ORAL RLD, RS 2020-11-10 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N213135-001 SUTAB 0.225GM;0.188GM;1.479GM TABLET / ORAL RLD, RS 2020-11-10 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N213135-001 SUTAB 0.225GM;0.188GM;1.479GM TABLET / ORAL RLD, RS 2020-11-10 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N213135-001 SUTAB 0.225GM;0.188GM;1.479GM TABLET / ORAL RLD, RS 2020-11-10 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N213135-001 SUTAB 0.225GM;0.188GM;1.479GM TABLET / ORAL RLD, RS 2020-11-10 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 N213135-001 SUTAB 0.225GM;0.188GM;1.479GM TABLET / ORAL RLD, RS 2020-11-10 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N213135-001 SUTAB 0.225GM;0.188GM;1.479GM TABLET / ORAL RLD, RS 2020-11-10 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N213135-001 SUTAB (COPACKAGED) 0.225GM;0.188GM;1.479GM TABLET / ORAL RLD, RS 2020-11-10 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N213135-001 SUTAB (COPACKAGED) 0.225GM;0.188GM;1.479GM TABLET / ORAL RLD, RS 2020-11-10 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N213135-001 SUTAB (COPACKAGED) 0.225GM;0.188GM;1.479GM TABLET / ORAL RLD, RS 2020-11-10 8869cabd3fbd…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N213135-001 SUTAB 0.225GM;0.188GM;1.479GM TABLET / ORAL RLD, RS 2020-11-10 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N213135-001 SUTAB 0.225GM;0.188GM;1.479GM TABLET / ORAL RLD, RS 2020-11-10 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N213135-001 SUTAB 0.225GM;0.188GM;1.479GM TABLET / ORAL RLD, RS 2020-11-10 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N213135-001 SUTAB 0.225GM;0.188GM;1.479GM TABLET / ORAL RLD, RS 2020-11-10 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N213135-001 SUTAB 0.225GM;0.188GM;1.479GM TABLET / ORAL RLD, RS 2020-11-10 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N213135-001 SUTAB 0.225GM;0.188GM;1.479GM TABLET / ORAL RLD, RS 2020-11-10 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N213135-001 SUTAB 0.225GM;0.188GM;1.479GM TABLET / ORAL RLD, RS 2020-11-10 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N213135-001 SUTAB 0.225GM;0.188GM;1.479GM TABLET / ORAL RLD, RS 2020-11-10 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N213135-001 SUTAB 0.225GM;0.188GM;1.479GM TABLET / ORAL RLD, RS 2020-11-10 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N213135-001 SUTAB 0.225GM;0.188GM;1.479GM TABLET / ORAL RLD, RS 2020-11-10 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N213135-001 SUTAB 0.225GM;0.188GM;1.479GM TABLET / ORAL RLD, RS 2020-11-10 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N213135-001 SUTAB 0.225GM;0.188GM;1.479GM TABLET / ORAL RLD, RS 2020-11-10 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N213135-001 SUTAB 0.225GM;0.188GM;1.479GM TABLET / ORAL RLD, RS 2020-11-10 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N213135-001 SUTAB 0.225GM;0.188GM;1.479GM TABLET / ORAL AB RLD, RS 2020-11-10 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N213135-001 AB 1 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 3 · 118 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N213135-001 10143656 2037-08-04 Drug product 2020-11-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213135-001 11033498 2037-08-04 U-3164 2021-07-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213135-001 11382864 2037-08-04 U-3164 2022-08-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213135-001 11638697 2037-08-04 Drug product 2023-05-31 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213135-001 10143656 2037-08-04 Drug product 2020-11-13 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213135-001 11033498 2037-08-04 U-3164 2021-07-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213135-001 11382864 2037-08-04 U-3164 2022-08-04 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213135-001 11638697 2037-08-04 Drug product 2023-05-31 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N213135-001 10143656 2037-08-04 Drug product 2020-11-13 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N213135-001 11033498 2037-08-04 U-3164 2021-07-02 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N213135-001 11382864 2037-08-04 U-3164 2022-08-04 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N213135-001 11638697 2037-08-04 Drug product 2023-05-31 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N213135-001 10143656 2037-08-04 Drug product 2020-11-13 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N213135-001 11033498 2037-08-04 U-3164 2021-07-02 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N213135-001 11382864 2037-08-04 U-3164 2022-08-04 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N213135-001 11638697 2037-08-04 Drug product 2023-05-31 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N213135-001 10143656 2037-08-04 Drug product 2020-11-13 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N213135-001 11033498 2037-08-04 U-3164 2021-07-02 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N213135-001 11382864 2037-08-04 U-3164 2022-08-04 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N213135-001 11638697 2037-08-04 Drug product 2023-05-31 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N213135-001 10143656 2037-08-04 Drug product 2020-11-13 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N213135-001 11033498 2037-08-04 U-3164 2021-07-02 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N213135-001 11382864 2037-08-04 U-3164 2022-08-04 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N213135-001 11638697 2037-08-04 Drug product 2023-05-31 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N213135-001 10143656 2037-08-04 Drug product 2020-11-13 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N213135-001 11033498 2037-08-04 U-3164 2021-07-02 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N213135-001 11382864 2037-08-04 U-3164 2022-08-04 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N213135-001 11638697 2037-08-04 Drug product 2023-05-31 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N213135-001 10143656 2037-08-04 Drug product 2020-11-13 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N213135-001 11033498 2037-08-04 U-3164 2021-07-02 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N213135-001 11382864 2037-08-04 U-3164 2022-08-04 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N213135-001 11638697 2037-08-04 Drug product 2023-05-31 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N213135-001 10143656 2037-08-04 Drug product 2020-11-13 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N213135-001 11033498 2037-08-04 U-3164 2021-07-02 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N213135-001 11382864 2037-08-04 U-3164 2022-08-04 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N213135-001 11638697 2037-08-04 Drug product 2023-05-31 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N213135-001 10143656 2037-08-04 Drug product 2020-11-13 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N213135-001 11033498 2037-08-04 U-3164 2021-07-02 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N213135-001 11382864 2037-08-04 U-3164 2022-08-04 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N213135-001 11638697 2037-08-04 Drug product 2023-05-31 d06236e962d9…
Observed Orange Book exclusivity history# Additional Listing Data#
Finished product Yes
Brand name base SUTAB
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SODIUM SULFATE 2.7 g/1 MAGNESIUM SULFATE ANHYDROUS 2.25 g/1 POTASSIUM CHLORIDE 17.75 g/1
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 ML30MJ2U7I Internal UNII lookup 660YQ98I10 Internal UNII 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 52268-201-01 SUTAB 2 in 1 KIT TABLET 2 6 52268-201-01 SUTAB 12 in 1 BOTTLE, PLASTIC TABLET 12 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 52268-201 SUTAB (SODIUM SULFATE, MAGNESIUM SULFATE, AND POTASSIUM CHLORIDE) TABLET [BRAINTREE LABORATORIES, INC.] 6 Current NDC, Legacy NDC, 2 package rows 20231104_dddd2701-4d46-44de-a9f8-303d4dcceef7.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 · 2 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join SUTAB SODIUM SULFATE, MAGNESIUM SULFATE, AND POTASSIUM CHLORIDE Azurity Pharmaceuticals, Inc. c020e973-dccf-4862-999e-17db6209a48a 2026-01-31 Warnings, Adverse reactions Exact identifier application applno (NDA): 213135 application number: NDA213135 SUTAB SODIUM SULFATE, MAGNESIUM SULFATE, AND POTASSIUM CHLORIDE Braintree Laboratories, Inc. dddd2701-4d46-44de-a9f8-303d4dcceef7 2023-11-03 Warnings, Adverse reactions Exact identifier application applno (NDA): 213135 application number: NDA213135 ndc (package): 52268-201-01 ndc (product): 52268-201 ndc11 (package): 52268020101
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 52268-201-01 52268020101 2 BOTTLE, PLASTIC in 1 KIT (52268-201-01) / 12 TABLET in 1 BOTTLE, PLASTIC 2020-11-10 0000-00-00 No No Current