Home NDC 0378-9205 sucralfate
Product NDC 0378-9205
11-digit product format 003789205
Labeler code 0378
Product ID 0378-9205_107f926c-dcf7-4a04-a44a-e22ff1534f97
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name sucralfate
Dosage form SUSPENSION
Route ORAL
Labeler Mylan Pharmaceuticals Inc.
Application ANDA212913
Marketing category ANDA
Marketing start 2022-09-22
Marketing end 2026-09-30
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 A212913-001 SUCRALFATE SUCRALFATE 1GM/10ML SUSPENSION / ORAL AB 2022-09-12
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A212913-001 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 A212913-001 SUCRALFATE 1GM/10ML SUSPENSION / ORAL AB 2022-09-12 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A212913-001 SUCRALFATE 1GM/10ML SUSPENSION / ORAL AB 2022-09-12 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212913-001 SUCRALFATE 1GM/10ML SUSPENSION / ORAL AB 2022-09-12 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A212913-001 SUCRALFATE 1GM/10ML SUSPENSION / ORAL AB 2022-09-12 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212913-001 SUCRALFATE 1GM/10ML SUSPENSION / ORAL AB 2022-09-12 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A212913-001 SUCRALFATE 1GM/10ML SUSPENSION / ORAL AB 2022-09-12 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A212913-001 SUCRALFATE 1GM/10ML SUSPENSION / ORAL AB 2022-09-12 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A212913-001 SUCRALFATE 1GM/10ML SUSPENSION / ORAL AB 2022-09-12 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A212913-001 SUCRALFATE 1GM/10ML SUSPENSION / ORAL AB 2022-09-12 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A212913-001 SUCRALFATE 1GM/10ML SUSPENSION / ORAL AB 2022-09-12 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A212913-001 SUCRALFATE 1GM/10ML SUSPENSION / ORAL AB 2022-09-12 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A212913-001 SUCRALFATE 1GM/10ML SUSPENSION / ORAL AB 2022-09-12 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A212913-001 SUCRALFATE 1GM/10ML SUSPENSION / ORAL AB 2022-09-12 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A212913-001 SUCRALFATE 1GM/10ML SUSPENSION / ORAL AB 2022-09-12 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A212913-001 SUCRALFATE 1GM/10ML SUSPENSION / ORAL AB 2022-09-12 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A212913-001 SUCRALFATE 1GM/10ML SUSPENSION / ORAL AB 2022-09-12 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A212913-001 SUCRALFATE 1GM/10ML SUSPENSION / ORAL AB 2022-09-12 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A212913-001 SUCRALFATE 1GM/10ML SUSPENSION / ORAL AB 2022-09-12 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A212913-001 SUCRALFATE 1GM/10ML SUSPENSION / ORAL AB 2022-09-12 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A212913-001 SUCRALFATE 1GM/10ML SUSPENSION / ORAL AB 2022-09-12 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A212913-001 SUCRALFATE 1GM/10ML SUSPENSION / ORAL AB 2022-09-12 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A212913-001 SUCRALFATE 1GM/10ML SUSPENSION / ORAL AB 2022-09-12 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A212913-001 SUCRALFATE 1GM/10ML SUSPENSION / ORAL AB 2022-09-12 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A212913-001 SUCRALFATE 1GM/10ML SUSPENSION / ORAL AB 2022-09-12 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A212913-001 SUCRALFATE 1GM/10ML SUSPENSION / ORAL AB 2022-09-12 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A212913-001 SUCRALFATE 1GM/10ML SUSPENSION / ORAL AB 2022-09-12 f41ea6bd6efb…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A212913-001 SUCRALFATE 1GM/10ML SUSPENSION / ORAL AB 2022-09-12 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base sucralfate 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 0378-9205-35 sucralfate 420 mL in 1 BOTTLE, PLASTIC SUSPENSION 420 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0378-9205 SUCRALFATE SUSPENSION [MYLAN PHARMACEUTICALS INC.] 2 Current NDC, Legacy NDC, 1 package rows 20220924_1e781cc0-24ec-4028-8262-dcef9873ea1f.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 · 1 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 0378-9205-35 00378920535 420 mL in 1 BOTTLE, PLASTIC (0378-9205-35) 420 ml 2022-09-22 0000-00-00 No No Current