Home NDC 17856-0306 Sucralfate
Product NDC 17856-0306
11-digit product format 178560306
Labeler code 17856
Product ID 17856-0306_361f83ba-0caa-c1c1-e063-6394a90a4c10
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Sucralfate
Dosage form SUSPENSION
Route ORAL
Labeler ATLANTIC BIOLOGICALS CORP.
Application ANDA211884
Marketing category ANDA
Marketing start 2022-03-15
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 Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 10 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-03-22 03:12 UTC · source 2025-03-21 excluded product product I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 17856-0306-1 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 17856-0306-1 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 17856-0306-1 U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 17856-0306-1 U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 17856-0306-1 U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…
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 A211884-001 SUCRALFATE SUCRALFATE 1GM/10ML SUSPENSION / ORAL AB RS 2022-03-15
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A211884-001 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 A211884-001 SUCRALFATE 1GM/10ML SUSPENSION / ORAL AB RS 2022-03-15 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A211884-001 SUCRALFATE 1GM/10ML SUSPENSION / ORAL AB 2022-03-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211884-001 SUCRALFATE 1GM/10ML SUSPENSION / ORAL AB 2022-03-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A211884-001 SUCRALFATE 1GM/10ML SUSPENSION / ORAL AB 2022-03-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211884-001 SUCRALFATE 1GM/10ML SUSPENSION / ORAL AB 2022-03-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211884-001 SUCRALFATE 1GM/10ML SUSPENSION / ORAL AB 2022-03-15 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211884-001 SUCRALFATE 1GM/10ML SUSPENSION / ORAL AB 2022-03-15 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211884-001 SUCRALFATE 1GM/10ML SUSPENSION / ORAL AB 2022-03-15 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211884-001 SUCRALFATE 1GM/10ML SUSPENSION / ORAL AB 2022-03-15 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211884-001 SUCRALFATE 1GM/10ML SUSPENSION / ORAL AB 2022-03-15 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A211884-001 SUCRALFATE 1GM/10ML SUSPENSION / ORAL AB 2022-03-15 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A211884-001 SUCRALFATE 1GM/10ML SUSPENSION / ORAL AB 2022-03-15 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A211884-001 SUCRALFATE 1GM/10ML SUSPENSION / ORAL AB 2022-03-15 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A211884-001 SUCRALFATE 1GM/10ML SUSPENSION / ORAL AB 2022-03-15 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A211884-001 SUCRALFATE 1GM/10ML SUSPENSION / ORAL AB 2022-03-15 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A211884-001 SUCRALFATE 1GM/10ML SUSPENSION / ORAL AB 2022-03-15 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A211884-001 SUCRALFATE 1GM/10ML SUSPENSION / ORAL AB 2022-03-15 5d02ea3f76ae…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A211884-001 SUCRALFATE 1GM/10ML SUSPENSION / ORAL AB 2022-03-15 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A211884-001 SUCRALFATE 1GM/10ML SUSPENSION / ORAL AB 2022-03-15 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A211884-001 SUCRALFATE 1GM/10ML SUSPENSION / ORAL AB 2022-03-15 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A211884-001 SUCRALFATE 1GM/10ML SUSPENSION / ORAL AB 2022-03-15 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A211884-001 SUCRALFATE 1GM/10ML SUSPENSION / ORAL AB 2022-03-15 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A211884-001 SUCRALFATE 1GM/10ML SUSPENSION / ORAL AB 2022-03-15 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A211884-001 SUCRALFATE 1GM/10ML SUSPENSION / ORAL AB 2022-03-15 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A211884-001 SUCRALFATE 1GM/10ML SUSPENSION / ORAL AB 2022-03-15 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A211884-001 SUCRALFATE 1GM/10ML SUSPENSION / ORAL AB 2022-03-15 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A211884-001 SUCRALFATE 1GM/10ML SUSPENSION / ORAL AB 2022-03-15 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A211884-001 SUCRALFATE 1GM/10ML SUSPENSION / ORAL AB 2022-03-15 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A211884-001 SUCRALFATE 1GM/10ML SUSPENSION / ORAL AB 2022-03-15 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A211884-001 SUCRALFATE 1GM/10ML SUSPENSION / ORAL AB 2022-03-15 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A211884-001 SUCRALFATE 1GM/10ML SUSPENSION / ORAL AB RS 2022-03-15 a50c72e98297…
Observed Orange Book normalized TE history# Observed Orange Book exclusivity history# Captured, Edition, Application-product table Captured Edition Application-product Exclusivity code Expiration Source SHA-256 2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A211884-001 CGT 2022-09-11 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A211884-001 CGT 2022-09-11 5d02ea3f76ae…2023-01-26 05:58 UTC 2023-01 A211884-001 CGT 2022-09-11 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A211884-001 CGT 2022-09-11 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A211884-001 CGT 2022-09-11 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A211884-001 CGT 2022-09-11 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A211884-001 CGT 2022-09-11 cb3db0bc1861…
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# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 17856-0306-1 Sucralfate 72 in 1 BOX, UNIT-DOSE SUSPENSION 72 3 17856-0306-1 Sucralfate 10 mL in 1 CUP, UNIT-DOSE SUSPENSION 10 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 17856-0306 SUCRALFATE SUSPENSION [ATLANTIC BIOLOGICALS CORP.] 3 Current NDC, 2 package rows 20250529_e5073597-ac51-4e7c-a9dc-7695773a01f1.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 · 6 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Sucralfate SUCRALFATE Cardinal Health 107, LLC 92c8672a-c6b8-4ec8-a815-c30bdd960ac7 2026-03-30 Warnings, Adverse reactions Exact identifier application applno (ANDA): 211884 application number: ANDA211884 Sucralfate SUCRALFATE PAI Holdings, LLC dba PAI Pharma 113a068a-2ce9-421c-8b89-87ce30e19225 2026-03-11 Warnings, Adverse reactions Exact identifier application applno (ANDA): 211884 application number: ANDA211884 Sucralfate SUCRALFATE ORAL SUSPENSION Major Pharmaceuticals 98a8fedd-fa06-416a-8a85-b899631978f9 2026-02-11 Warnings, Adverse reactions Exact identifier application applno (ANDA): 211884 application number: ANDA211884 Sucralfate SUCRALFATE ATLANTIC BIOLOGICALS CORP. e5073597-ac51-4e7c-a9dc-7695773a01f1 2025-05-27 Warnings, Adverse reactions Exact identifier application applno (ANDA): 211884 application number: ANDA211884 ndc (product): 17856-0306 Sucralfate SUCRALFATE VistaPharm, LLC cbfbe146-5d42-4a55-9050-df2b5581487a 2023-12-18 Warnings, Adverse reactions Exact identifier application applno (ANDA): 211884 application number: ANDA211884 Sucralfate SUCRALFATE American Health Packaging e4761fb2-6a1a-44de-9d27-f6addabc24c8 2023-08-10 Warnings, Adverse reactions Exact identifier application applno (ANDA): 211884 application number: ANDA211884
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 17856-0306-1 17856030601 72 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (17856-0306-1) / 10 mL in 1 CUP, UNIT-DOSE 2023-08-10 No No Current