Home NDC 58914-170 Carafate
Product NDC 58914-170
11-digit product format 589140170
Labeler code 58914
Product ID 58914-170_cb835be9-f4ba-47c4-b1db-d2f731371432
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Sucralfate
Dosage form SUSPENSION
Route ORAL
Labeler Allergan, Inc.
Application NDA019183
Marketing category NDA
Marketing start 1993-12-16
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 N019183-001 CARAFATE SUCRALFATE 1GM/10ML SUSPENSION / ORAL RLD 1993-12-16
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.
Product history page 1 of 2 · 42 observed 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 N019183-001 CARAFATE 1GM/10ML SUSPENSION / ORAL RLD 1993-12-16 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N019183-001 CARAFATE 1GM/10ML SUSPENSION / ORAL AB RLD, RS 1993-12-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019183-001 CARAFATE 1GM/10ML SUSPENSION / ORAL AB RLD, RS 1993-12-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N019183-001 CARAFATE 1GM/10ML SUSPENSION / ORAL AB RLD, RS 1993-12-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N019183-001 CARAFATE 1GM/10ML SUSPENSION / ORAL AB RLD, RS 1993-12-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N019183-001 CARAFATE 1GM/10ML SUSPENSION / ORAL AB RLD, RS 1993-12-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N019183-001 CARAFATE 1GM/10ML SUSPENSION / ORAL AB RLD, RS 1993-12-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N019183-001 CARAFATE 1GM/10ML SUSPENSION / ORAL AB RLD, RS 1993-12-16 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N019183-001 CARAFATE 1GM/10ML SUSPENSION / ORAL AB RLD, RS 1993-12-16 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N019183-001 CARAFATE 1GM/10ML SUSPENSION / ORAL AB RLD, RS 1993-12-16 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N019183-001 CARAFATE 1GM/10ML SUSPENSION / ORAL AB RLD, RS 1993-12-16 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N019183-001 CARAFATE 1GM/10ML SUSPENSION / ORAL AB RLD, RS 1993-12-16 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N019183-001 CARAFATE 1GM/10ML SUSPENSION / ORAL AB RLD, RS 1993-12-16 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N019183-001 CARAFATE 1GM/10ML SUSPENSION / ORAL AB RLD, RS 1993-12-16 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N019183-001 CARAFATE 1GM/10ML SUSPENSION / ORAL AB RLD, RS 1993-12-16 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N019183-001 CARAFATE 1GM/10ML SUSPENSION / ORAL AB RLD, RS 1993-12-16 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N019183-001 CARAFATE 1GM/10ML SUSPENSION / ORAL AB RLD, RS 1993-12-16 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N019183-001 CARAFATE 1GM/10ML SUSPENSION / ORAL AB RLD, RS 1993-12-16 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N019183-001 CARAFATE 1GM/10ML SUSPENSION / ORAL RLD, RS 1993-12-16 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N019183-001 CARAFATE 1GM/10ML SUSPENSION / ORAL AB RLD, RS 1993-12-16 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N019183-001 CARAFATE 1GM/10ML SUSPENSION / ORAL AB RLD, RS 1993-12-16 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N019183-001 CARAFATE 1GM/10ML SUSPENSION / ORAL AB RLD, RS 1993-12-16 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N019183-001 CARAFATE 1GM/10ML SUSPENSION / ORAL AB RLD, RS 1993-12-16 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N019183-001 CARAFATE 1GM/10ML SUSPENSION / ORAL AB RLD, RS 1993-12-16 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N019183-001 CARAFATE 1GM/10ML SUSPENSION / ORAL AB RLD, RS 1993-12-16 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N019183-001 CARAFATE 1GM/10ML SUSPENSION / ORAL AB RLD, RS 1993-12-16 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N019183-001 CARAFATE 1GM/10ML SUSPENSION / ORAL RLD, RS 1993-12-16 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N019183-001 CARAFATE 1GM/10ML SUSPENSION / ORAL RLD, RS 1993-12-16 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N019183-001 CARAFATE 1GM/10ML SUSPENSION / ORAL AB RLD, RS 1993-12-16 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N019183-001 CARAFATE 1GM/10ML SUSPENSION / ORAL AB RLD, RS 1993-12-16 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N019183-001 CARAFATE 1GM/10ML SUSPENSION / ORAL AB RLD, RS 1993-12-16 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N019183-001 CARAFATE 1GM/10ML SUSPENSION / ORAL AB RLD, RS 1993-12-16 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N019183-001 CARAFATE 1GM/10ML SUSPENSION / ORAL AB RLD, RS 1993-12-16 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N019183-001 CARAFATE 1GM/10ML SUSPENSION / ORAL AB RLD, RS 1993-12-16 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N019183-001 CARAFATE 1GM/10ML SUSPENSION / ORAL AB RLD, RS 1993-12-16 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N019183-001 CARAFATE 1GM/10ML SUSPENSION / ORAL AB RLD, RS 1993-12-16 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N019183-001 CARAFATE 1GM/10ML SUSPENSION / ORAL AB RLD, RS 1993-12-16 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N019183-001 CARAFATE 1GM/10ML SUSPENSION / ORAL AB RLD, RS 1993-12-16 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N019183-001 CARAFATE 1GM/10ML SUSPENSION / ORAL AB RLD, RS 1993-12-16 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N019183-001 CARAFATE 1GM/10ML SUSPENSION / ORAL AB RLD, RS 1993-12-16 e64feba35796…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Carafate
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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 208094 Internal RxNorm lookup 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 58914-170-14 Carafate 420 mL in 1 BOTTLE SUSPENSION 420 20 58914-170-60 Carafate 6 in 1 BOX SUSPENSION 6 20 58914-170-60 Carafate 10 mL in 1 CUP, UNIT-DOSE SUSPENSION 10 20
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Sucralfate ACTIVE INGREDIENT XX73205DH5 CARAFATE (SUCRALFATE) SUSPENSION [APTALIS PHARMA INC.] 8 Sucralfate ACTIVE MOIETY XX73205DH5 CARAFATE (SUCRALFATE) SUSPENSION [APTALIS PHARMA INC.] 8 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA CARAFATE (SUCRALFATE) SUSPENSION [APTALIS PHARMA INC.] 8 Glycerin INACTIVE INGREDIENT PDC6A3C0OX CARAFATE (SUCRALFATE) SUSPENSION [APTALIS PHARMA INC.] 8 Methylparaben INACTIVE INGREDIENT A2I8C7HI9T CARAFATE (SUCRALFATE) SUSPENSION [APTALIS PHARMA INC.] 8 Sorbitol INACTIVE INGREDIENT 506T60A25R CARAFATE (SUCRALFATE) SUSPENSION [APTALIS PHARMA INC.] 8 Water INACTIVE INGREDIENT 059QF0KO0R CARAFATE (SUCRALFATE) SUSPENSION [APTALIS PHARMA INC.] 8 Sucralfate ACTIVE INGREDIENT XX73205DH5 SUCRALFATE SUSPENSION [PRECISION DOSE INC.] 2 Sucralfate ACTIVE INGREDIENT XX73205DH5 SUCRALFATE SUSPENSION [PHARMACEUTICAL ASSOCIATES, INC.] 2 Sucralfate ACTIVE INGREDIENT XX73205DH5 CARAFATE (SUCRALFATE) SUSPENSION [PHYSICIANS TOTAL CARE, INC.] 2 Sucralfate ACTIVE MOIETY XX73205DH5 SUCRALFATE SUSPENSION [PRECISION DOSE INC.] 2 Sucralfate ACTIVE MOIETY XX73205DH5 CARAFATE (SUCRALFATE) SUSPENSION [PHYSICIANS TOTAL CARE, INC.] 2 Sucralfate ACTIVE MOIETY XX73205DH5 SUCRALFATE SUSPENSION [PHARMACEUTICAL ASSOCIATES, INC.] 2 cellulose, microcrystalline INACTIVE INGREDIENT OP1R32D61U SUCRALFATE SUSPENSION [PRECISION DOSE INC.] 2 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA CARAFATE (SUCRALFATE) SUSPENSION [PHYSICIANS TOTAL CARE, INC.] 2 FD&C red NO. 40 INACTIVE INGREDIENT WZB9127XOA SUCRALFATE SUSPENSION [PRECISION DOSE INC.] 2 glycerin INACTIVE INGREDIENT PDC6A3C0OX SUCRALFATE SUSPENSION [PRECISION DOSE INC.] 2 Glycerin INACTIVE INGREDIENT PDC6A3C0OX CARAFATE (SUCRALFATE) SUSPENSION [PHYSICIANS TOTAL CARE, INC.] 2 Methylparaben INACTIVE INGREDIENT A2I8C7HI9T CARAFATE (SUCRALFATE) SUSPENSION [PHYSICIANS TOTAL CARE, INC.] 2 methylparaben INACTIVE INGREDIENT A2I8C7HI9T SUCRALFATE SUSPENSION [PRECISION DOSE INC.] 2 silicon dioxide INACTIVE INGREDIENT ETJ7Z6XBU4 SUCRALFATE SUSPENSION [PRECISION DOSE INC.] 2 Sorbitol INACTIVE INGREDIENT 506T60A25R CARAFATE (SUCRALFATE) SUSPENSION [PHYSICIANS TOTAL CARE, INC.] 2 sorbitol INACTIVE INGREDIENT 506T60A25R SUCRALFATE SUSPENSION [PRECISION DOSE INC.] 2 SORBITOL INACTIVE INGREDIENT 506T60A25R SUCRALFATE SUSPENSION [PHARMACEUTICAL ASSOCIATES, INC.] 2 water INACTIVE INGREDIENT 059QF0KO0R SUCRALFATE SUSPENSION [PRECISION DOSE INC.] 2 Water INACTIVE INGREDIENT 059QF0KO0R CARAFATE (SUCRALFATE) SUSPENSION [PHYSICIANS TOTAL CARE, INC.] 2 SUCRALFATE ACTIVE INGREDIENT XX73205DH5 SUCRALFATE SUSPENSION [PHYSICIANS TOTAL CARE, INC.] 1 Sucralfate ACTIVE INGREDIENT XX73205DH5 SUCRALFATE SUSPENSION [VISTAPHARM, INC.] 1 SUCRALFATE ACTIVE MOIETY XX73205DH5 SUCRALFATE SUSPENSION [PHYSICIANS TOTAL CARE, INC.] 1 Sucralfate ACTIVE MOIETY XX73205DH5 SUCRALFATE SUSPENSION [VISTAPHARM, INC.] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U SUCRALFATE SUSPENSION [PHYSICIANS TOTAL CARE, INC.] 1 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA SUCRALFATE SUSPENSION [PHYSICIANS TOTAL CARE, INC.] 1 FD&C Red No. 40 INACTIVE INGREDIENT WZB9127XOA SUCRALFATE SUSPENSION [VISTAPHARM, INC.] 1 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX SUCRALFATE SUSPENSION [PHYSICIANS TOTAL CARE, INC.] 1 Glycerin INACTIVE INGREDIENT PDC6A3C0OX SUCRALFATE SUSPENSION [VISTAPHARM, INC.] 1 Methylparaben INACTIVE INGREDIENT A2I8C7HI9T SUCRALFATE SUSPENSION [VISTAPHARM, INC.] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 SUCRALFATE SUSPENSION [PHYSICIANS TOTAL CARE, INC.] 1 Sorbitol INACTIVE INGREDIENT 506T60A25R SUCRALFATE SUSPENSION [VISTAPHARM, INC.] 1 SORBITOL INACTIVE INGREDIENT 506T60A25R SUCRALFATE SUSPENSION [PHYSICIANS TOTAL CARE, INC.] 1 Water INACTIVE INGREDIENT 059QF0KO0R SUCRALFATE SUSPENSION [VISTAPHARM, INC.] 1 WATER INACTIVE INGREDIENT 059QF0KO0R SUCRALFATE SUSPENSION [PHYSICIANS TOTAL CARE, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 58914-170 CARAFATE (SUCRALFATE) SUSPENSION [ALLERGAN, INC.] 20 Current NDC, Legacy NDC, 3 package rows 20240207_0fb67b1c-b4c0-46f2-8a81-df1510e006aa.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 · 2 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 58914-170-14 58914017014 420 mL in 1 BOTTLE (58914-170-14) 420 ml 1993-12-16 0000-00-00 No No Current 58914-170-60 58914017060 6 CUP, UNIT-DOSE in 1 BOX (58914-170-60) / 10 mL in 1 CUP, UNIT-DOSE 1993-12-16 0000-00-00 Yes No Current