Home NDC 52268-550 SUFLAVE
Product NDC 52268-550
11-digit product format 522680550
Labeler code 52268
Product ID 52268-550_ff5c09e0-dd90-12a1-e053-6294a90ab8a9
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name polyethylene glycol 3350, sodium sulfate, potassium chloride, magnesium sulfate, and sodium chloride for oral solution
Dosage form KIT
Labeler Braintree Laboratories, Inc.
Application NDA215344
Marketing category NDA
Marketing start 2023-06-15
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 N215344-001 SUFLAVE MAGNESIUM SULFATE; POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM SULFATE 0.9GM/BOT;178.7GM/BOT;1.12GM/BOT;0.5GM/BOT;7.3GM/BOT FOR SOLUTION / ORAL RLD, RS 2023-06-15
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 N215344-001 12239659 2044-06-14 U-4143 2025-03-04 N215344-001 12433914 2044-06-14 U-4143 2025-11-06 N215344-001 12594298 2044-06-14 Drug product 2026-04-24 N215344-001 12290529 2044-08-02 Drug product 2025-05-09
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 1 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N215344-001 NP 2026-06-15
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 N215344-001 SUFLAVE 0.9GM/BOT;178.7GM/BOT;1.12GM/BOT;0.5GM/BOT;7.3GM/BOT FOR SOLUTION / ORAL RLD, RS 2023-06-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215344-001 SUFLAVE 0.9GM/BOT;178.7GM/BOT;1.12GM/BOT;0.5GM/BOT;7.3GM/BOT FOR SOLUTION / ORAL RLD, RS 2023-06-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N215344-001 SUFLAVE 0.9GM/BOT;178.7GM/BOT;1.12GM/BOT;0.5GM/BOT;7.3GM/BOT FOR SOLUTION / ORAL RLD, RS 2023-06-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N215344-001 SUFLAVE 0.9GM/BOT;178.7GM/BOT;1.12GM/BOT;0.5GM/BOT;7.3GM/BOT FOR SOLUTION / ORAL RLD, RS 2023-06-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N215344-001 SUFLAVE 0.9GM/BOT;178.7GM/BOT;1.12GM/BOT;0.5GM/BOT;7.3GM/BOT FOR SOLUTION / ORAL RLD, RS 2023-06-15 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N215344-001 SUFLAVE 0.9GM/BOT;178.7GM/BOT;1.12GM/BOT;0.5GM/BOT;7.3GM/BOT FOR SOLUTION / ORAL RLD, RS 2023-06-15 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N215344-001 SUFLAVE 0.9GM/BOT;178.7GM/BOT;1.12GM/BOT;0.5GM/BOT;7.3GM/BOT FOR SOLUTION / ORAL RLD, RS 2023-06-15 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N215344-001 SUFLAVE 0.9GM/BOT;178.7GM/BOT;1.12GM/BOT;0.5GM/BOT;7.3GM/BOT FOR SOLUTION / ORAL RLD, RS 2023-06-15 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N215344-001 SUFLAVE 0.9GM/BOT;178.7GM/BOT;1.12GM/BOT;0.5GM/BOT;7.3GM/BOT FOR SOLUTION / ORAL RLD, RS 2023-06-15 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N215344-001 SUFLAVE 0.9GM/BOT;178.7GM/BOT;1.12GM/BOT;0.5GM/BOT;7.3GM/BOT FOR SOLUTION / ORAL RLD, RS 2023-06-15 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N215344-001 SUFLAVE 0.9GM/BOT;178.7GM/BOT;1.12GM/BOT;0.5GM/BOT;7.3GM/BOT FOR SOLUTION / ORAL RLD, RS 2023-06-15 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N215344-001 SUFLAVE 0.9GM/BOT;178.7GM/BOT;1.12GM/BOT;0.5GM/BOT;7.3GM/BOT FOR SOLUTION / ORAL RLD, RS 2023-06-15 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N215344-001 SUFLAVE 0.9GM/BOT;178.7GM/BOT;1.12GM/BOT;0.5GM/BOT;7.3GM/BOT FOR SOLUTION / ORAL RLD, RS 2023-06-15 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N215344-001 SUFLAVE 0.9GM/BOT;178.7GM/BOT;1.12GM/BOT;0.5GM/BOT;7.3GM/BOT FOR SOLUTION / ORAL RLD, RS 2023-06-15 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N215344-001 SUFLAVE 0.9GM/BOT;178.7GM/BOT;1.12GM/BOT;0.5GM/BOT;7.3GM/BOT FOR SOLUTION / ORAL RLD, RS 2023-06-15 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N215344-001 SUFLAVE 0.9GM/BOT;178.7GM/BOT;1.12GM/BOT;0.5GM/BOT;7.3GM/BOT FOR SOLUTION / ORAL RLD, RS 2023-06-15 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N215344-001 SUFLAVE 0.9GM/BOT;178.7GM/BOT;1.12GM/BOT;0.5GM/BOT;7.3GM/BOT FOR SOLUTION / ORAL RLD, RS 2023-06-15 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N215344-001 SUFLAVE 0.9GM/BOT;178.7GM/BOT;1.12GM/BOT;0.5GM/BOT;7.3GM/BOT FOR SOLUTION / ORAL RLD, RS 2023-06-15 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N215344-001 SUFLAVE 0.9GM/BOT;178.7GM/BOT;1.12GM/BOT;0.5GM/BOT;7.3GM/BOT FOR SOLUTION / ORAL RLD, RS 2023-06-15 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N215344-001 SUFLAVE 0.9GM/BOT;178.7GM/BOT;1.12GM/BOT;0.5GM/BOT;7.3GM/BOT FOR SOLUTION / ORAL RLD, RS 2023-06-15 a67488948f0b…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N215344-001 SUFLAVE 0.9GM/BOT;178.7GM/BOT;1.12GM/BOT;0.5GM/BOT;7.3GM/BOT FOR SOLUTION / ORAL RLD, RS 2023-06-15 a50c72e98297…
Observed Orange Book patent history# 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 N215344-001 12239659 2044-06-14 U-4143 2025-03-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215344-001 12433914 2044-06-14 U-4143 2025-11-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215344-001 12290529 2044-08-02 Drug product 2025-05-09 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215344-001 12239659 2044-06-14 U-4143 2025-03-04 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215344-001 12433914 2044-06-14 U-4143 2025-11-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215344-001 12290529 2044-08-02 Drug product 2025-05-09 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N215344-001 12239659 2044-06-14 U-4143 2025-03-04 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N215344-001 12290529 2044-08-02 Drug product 2025-05-09 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N215344-001 12239659 2044-06-14 U-4143 2025-03-04 fd3edfee7708…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N215344-001 12239659 2044-06-14 U-4143 2025-03-04 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N215344-001 12433914 2044-06-14 U-4143 2025-11-06 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N215344-001 12594298 2044-06-14 Drug product 2026-04-24 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N215344-001 12290529 2044-08-02 Drug product 2025-05-09 a50c72e98297…
Observed Orange Book exclusivity history# Additional Listing Data#
Finished product Yes
Brand name base SUFLAVE
Listing expiration 2026-12-31 Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2641142 Internal RxNorm lookup 2641143 Internal RxNorm lookup 2641144 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 52268-550-01 SUFLAVE 1 in 1 KIT KIT 1 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 52268-550 SUFLAVE (POLYETHYLENE GLYCOL 3350, SODIUM SULFATE, POTASSIUM CHLORIDE, MAGNESIUM SULFATE, AND SODIUM CHLORIDE FOR ORAL SOLUTION) KIT [BRAINTREE LABORATORIES, INC.] 1 Current NDC, 1 package rows 20230701_546cfc44-791c-4524-99a9-6a0af96c4ec8.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 SUFLAVE POLYETHYLENE GLYCOL 3350, SODIUM SULFATE, POTASSIUM CHLORIDE, MAGNESIUM SULFATE, AND SODIUM CHLORIDE FOR ORAL SOLUTION Azurity Pharmaceuticals, Inc. d5710a04-2b0a-402c-a8b0-025766f1a437 2026-01-31 Warnings, Adverse reactions Exact identifier application applno (NDA): 215344 application number: NDA215344 SUFLAVE POLYETHYLENE GLYCOL 3350, SODIUM SULFATE, POTASSIUM CHLORIDE, MAGNESIUM SULFATE, AND SODIUM CHLORIDE FOR ORAL SOLUTION Braintree Laboratories, Inc. 546cfc44-791c-4524-99a9-6a0af96c4ec8 2023-06-15 Warnings, Adverse reactions Exact identifier application applno (NDA): 215344 application number: NDA215344 ndc (product): 52268-550
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 52268-550-01 52268055001 1 KIT in 1 KIT (52268-550-01) 1 kit 2023-06-15 No No Current