Home NDC 69238-1656 Sucralfate
Product NDC 69238-1656
11-digit product format 692381656
Labeler code 69238
Product ID 69238-1656_507ba68d-7593-4545-bbe1-dc9463c1a893
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Sucralfate
Dosage form TABLET
Route ORAL
Labeler Amneal Pharmaceuticals NY LLC
Application ANDA215576
Marketing category ANDA
Marketing start 2022-04-22
Substance SUCRALFATE
Active strength 1 g/1
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 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 2026-12-31 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 69238-1656-1 Sucralfate 100 in 1 BOTTLE TABLET 100 6 69238-1656-5 Sucralfate 500 in 1 BOTTLE TABLET 500 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69238-1656 SUCRALFATE TABLET [AMNEAL PHARMACEUTICALS NY LLC] 6 Current NDC, Legacy NDC, 2 package rows 20231231_a4f722e7-2885-4f27-8358-9c662439600a.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 Marketing end Sample Exclude flag Status 69238-1656-1 69238165601 100 TABLET in 1 BOTTLE (69238-1656-1) 100 tablet 2022-04-22 0000-00-00 No No Current 69238-1656-5 69238165605 500 TABLET in 1 BOTTLE (69238-1656-5) 500 tablet 2022-05-23 0000-00-00 No No Current