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Active ingredient

Sucralfate

71 finished FDA listings contain Sucralfate as their only active ingredient.

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FDA NDC Directory

Ingredient names as written by FDA
SUCRALFATE
Dosage forms
Suspension, Tablet
Routes
Oral
Manufacturers / labelers
48
Strengths listed
1 g/1 · 1 g/10ml
Brand names in FDA listings
Carafate, Sucralfate, Sucralfate Oral Suspension

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 10156

Drugs@FDA applications

Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.

ApplicationSponsorOriginal approvalListings
NDA 018333ABBVIE1981-10-309
NDA 019183ABBVIE1993-12-162
ANDA 070848TEVA1996-03-2914
ANDA 074415CHARTWELL RX1998-06-0812
ANDA 209356AMNEAL2019-12-025
ANDA 211884VISTAPHARM LLC2022-03-156
ANDA 215576AMNEAL PHARMS2022-04-153
ANDA 212913MYLAN2022-09-121
ANDA 215705ZYDUS LIFESCIENCES2023-05-038
ANDA 213549PD PARTNERS2024-01-171
ANDA 216726ABON PHARMS LLC2024-03-212
ANDA 216474STRIDES PHARMA2024-05-213
ANDA 217126COSETTE PHARMS NC2024-11-132
ANDA 211780CHARTWELL RX2025-04-142
ANDA 212141GLENMARK PHARMS LTD2026-01-051

Official labeling on DailyMed

Showing the 12 most recent of 70 labels.

Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.