Home NDC 48433-226 Sucralfate
Product NDC 48433-226
11-digit product format 484330226
Labeler code 48433
Product ID 48433-226_56bc4a66-18f6-0c11-e063-6294a90a7e26
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Sucralfate
Dosage form SUSPENSION
Route ORAL
Labeler Safecor Health, LLC
Application ANDA217126
Marketing category ANDA
Marketing start 2026-07-16
Substance SUCRALFATE
Active strength 1 g/10mL
Pharmacologic classes Aluminum Complex [EPC], Organometallic Compounds [CS]
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 A217126-001 SUCRALFATE SUCRALFATE 1GM/10ML SUSPENSION / ORAL AB 2024-11-13
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A217126-001 AB
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 A217126-001 SUCRALFATE 1GM/10ML SUSPENSION / ORAL AB 2024-11-13 84e616aacf4f…2026-08-18 06:07:40 2026-07 A217126-001 SUCRALFATE 1GM/10ML SUSPENSION / ORAL AB 2024-11-13 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A217126-001 SUCRALFATE 1GM/10ML SUSPENSION / ORAL AB 2024-11-13 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217126-001 SUCRALFATE 1GM/10ML SUSPENSION / ORAL AB 2024-11-13 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A217126-001 SUCRALFATE 1GM/10ML SUSPENSION / ORAL AB 2024-11-13 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A217126-001 SUCRALFATE 1GM/10ML SUSPENSION / ORAL AB 2024-11-13 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A217126-001 SUCRALFATE 1GM/10ML SUSPENSION / ORAL AB 2024-11-13 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A217126-001 SUCRALFATE 1GM/10ML SUSPENSION / ORAL AB 2024-11-13 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A217126-001 SUCRALFATE 1GM/10ML SUSPENSION / ORAL AB 2024-11-13 2680178bc6a6…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A217126-001 SUCRALFATE 1GM/10ML SUSPENSION / ORAL AB 2024-11-13 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 Sucralfate
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SUCRALFATE 1 g/10mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination XX73205DH5 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 313123 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 48433-226-40 48433022640 40 CUP, UNIT-DOSE in 1 CASE (48433-226-40) / 10 mL in 1 CUP, UNIT-DOSE (48433-226-10) 2026-07-16 No No Current