Home NDC 54738-005 Sucralfate
Product NDC 54738-005
11-digit product format 547380005
Labeler code 54738
Product ID 54738-005_35d366c4-22fb-2cca-e063-6394a90a6980
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Sucralfate
Dosage form SUSPENSION
Route ORAL
Labeler Richmond Pharmaceuticals, Inc.
Application ANDA216726
Marketing category ANDA
Marketing start 2024-11-21
Substance SUCRALFATE
Active strength 1 g/10mL
Pharmacologic classes Aluminum Complex [EPC], Organometallic Compounds [CS]
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 42 .
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 A216726-001 SUCRALFATE SUCRALFATE 1GM/10ML SUSPENSION / ORAL AB 2024-03-21
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A216726-001 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 2026-08-18 06:07:40 2026-07 A216726-001 SUCRALFATE 1GM/10ML SUSPENSION / ORAL AB 2024-03-21 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A216726-001 SUCRALFATE 1GM/10ML SUSPENSION / ORAL AB 2024-03-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216726-001 SUCRALFATE 1GM/10ML SUSPENSION / ORAL AB 2024-03-21 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A216726-001 SUCRALFATE 1GM/10ML SUSPENSION / ORAL AB 2024-03-21 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216726-001 SUCRALFATE 1GM/10ML SUSPENSION / ORAL AB 2024-03-21 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216726-001 SUCRALFATE 1GM/10ML SUSPENSION / ORAL AB 2024-03-21 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216726-001 SUCRALFATE 1GM/10ML SUSPENSION / ORAL AB 2024-03-21 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A216726-001 SUCRALFATE 1GM/10ML SUSPENSION / ORAL AB 2024-03-21 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A216726-001 SUCRALFATE 1GM/10ML SUSPENSION / ORAL AB 2024-03-21 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A216726-001 SUCRALFATE 1GM/10ML SUSPENSION / ORAL AB 2024-03-21 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A216726-001 SUCRALFATE 1GM/10ML SUSPENSION / ORAL AB 2024-03-21 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A216726-001 SUCRALFATE 1GM/10ML SUSPENSION / ORAL AB 2024-03-21 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A216726-001 SUCRALFATE 1GM/10ML SUSPENSION / ORAL AB 2024-03-21 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A216726-001 SUCRALFATE 1GM/10ML SUSPENSION / ORAL AB 2024-03-21 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A216726-001 SUCRALFATE 1GM/10ML SUSPENSION / ORAL AB 2024-03-21 8072bd15b7f6…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A216726-001 SUCRALFATE 1GM/10ML SUSPENSION / ORAL AB 2024-03-21 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Sucralfate
Listing expiration 2026-12-31 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.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 54738-005-42 Sucralfate 420 mL in 1 BOTTLE SUSPENSION 420 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 54738-005 SUCRALFATE SUSPENSION [RICHMOND PHARMACEUTICALS, INC.] 2 Current NDC, 1 package rows 20250525_7ac10c3f-9d50-4702-900c-41075ac6f896.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 54738-005-42 54738000542 420 mL in 1 BOTTLE (54738-005-42) 420 ml 2025-05-22 No No Current