Home NDC 42291-936 Sucralfate
Product NDC 42291-936
11-digit product format 422910936
Labeler code 42291
Product ID 42291-936_48c0e47e-08b1-0c73-e063-6394a90a90b7
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Sucralfate
Dosage form TABLET
Route ORAL
Labeler AvKARE
Application ANDA215576
Marketing category ANDA
Marketing start 2023-10-31
Substance SUCRALFATE
Active strength 1 g/1
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 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 A215576-001 SUCRALFATE SUCRALFATE 1GM TABLET / ORAL AB 2022-04-15
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A215576-001 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 A215576-001 SUCRALFATE 1GM TABLET / ORAL AB 2022-04-15 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A215576-001 SUCRALFATE 1GM TABLET / ORAL AB 2022-04-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A215576-001 SUCRALFATE 1GM TABLET / ORAL AB 2022-04-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A215576-001 SUCRALFATE 1GM TABLET / ORAL AB 2022-04-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A215576-001 SUCRALFATE 1GM TABLET / ORAL AB 2022-04-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A215576-001 SUCRALFATE 1GM TABLET / ORAL AB 2022-04-15 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A215576-001 SUCRALFATE 1GM TABLET / ORAL AB 2022-04-15 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A215576-001 SUCRALFATE 1GM TABLET / ORAL AB 2022-04-15 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A215576-001 SUCRALFATE 1GM TABLET / ORAL AB 2022-04-15 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A215576-001 SUCRALFATE 1GM TABLET / ORAL AB 2022-04-15 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A215576-001 SUCRALFATE 1GM TABLET / ORAL AB 2022-04-15 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A215576-001 SUCRALFATE 1GM TABLET / ORAL AB 2022-04-15 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A215576-001 SUCRALFATE 1GM TABLET / ORAL AB 2022-04-15 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A215576-001 SUCRALFATE 1GM TABLET / ORAL AB 2022-04-15 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A215576-001 SUCRALFATE 1GM TABLET / ORAL AB 2022-04-15 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A215576-001 SUCRALFATE 1GM TABLET / ORAL AB 2022-04-15 5c6f7cd8ea54…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A215576-001 SUCRALFATE 1GM TABLET / ORAL AB 2022-04-15 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A215576-001 SUCRALFATE 1GM TABLET / ORAL AB 2022-04-15 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A215576-001 SUCRALFATE 1GM TABLET / ORAL AB 2022-04-15 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A215576-001 SUCRALFATE 1GM TABLET / ORAL AB 2022-04-15 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A215576-001 SUCRALFATE 1GM TABLET / ORAL AB 2022-04-15 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A215576-001 SUCRALFATE 1GM TABLET / ORAL AB 2022-04-15 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A215576-001 SUCRALFATE 1GM TABLET / ORAL AB 2022-04-15 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A215576-001 SUCRALFATE 1GM TABLET / ORAL AB 2022-04-15 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A215576-001 SUCRALFATE 1GM TABLET / ORAL AB 2022-04-15 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A215576-001 SUCRALFATE 1GM TABLET / ORAL AB 2022-04-15 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A215576-001 SUCRALFATE 1GM TABLET / ORAL AB 2022-04-15 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A215576-001 SUCRALFATE 1GM TABLET / ORAL AB 2022-04-15 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A215576-001 SUCRALFATE 1GM TABLET / ORAL AB 2022-04-15 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A215576-001 SUCRALFATE 1GM TABLET / ORAL AB 2022-04-15 a50c72e98297…
Observed Orange Book normalized TE history# 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/1
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 314234 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 42291-936-90 Sucralfate 90 in 1 BOTTLE TABLET 90 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 42291-936 SUCRALFATE TABLET [AVKARE] 1 Current NDC, 1 package rows 20231101_0909acc5-c746-17fb-e063-6394a90a677f.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 · 3 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 42291-936-90 42291093690 90 TABLET in 1 BOTTLE (42291-936-90) 90 tablet 2023-10-31 No No Current