Sucralfate

Product NDC
82182-106
Requested package NDC
82182-106-14
11-digit product format
821820106
Labeler code
82182
Product ID
82182-106_e171ec84-fb54-4598-a9e8-e37413ef2c64
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sucralfate
Dosage form
SUSPENSION
Route
ORAL
Labeler
Pacific Pharma, Inc.
Application
NDA019183
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2024-02-01
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 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N019183-001CARAFATESUCRALFATE1GM/10MLSUSPENSION / ORALRLD1993-12-16

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 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N019183-001CARAFATE1GM/10MLSUSPENSION / ORALABRLD, RS1993-12-16011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019183-001CARAFATE1GM/10MLSUSPENSION / ORALABRLD, RS1993-12-1631067a03dcf5…
2025-08-23 18:47 UTC2025-08N019183-001CARAFATE1GM/10MLSUSPENSION / ORALABRLD, RS1993-12-166a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019183-001CARAFATE1GM/10MLSUSPENSION / ORALABRLD, RS1993-12-16fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019183-001CARAFATE1GM/10MLSUSPENSION / ORALABRLD, RS1993-12-16b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019183-001CARAFATE1GM/10MLSUSPENSION / ORALABRLD, RS1993-12-1603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019183-001CARAFATE1GM/10MLSUSPENSION / ORALABRLD, RS1993-12-162680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019183-001CARAFATE1GM/10MLSUSPENSION / ORALABRLD, RS1993-12-165bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N019183-001CARAFATE1GM/10MLSUSPENSION / ORALABRLD, RS1993-12-16d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N019183-001CARAFATE1GM/10MLSUSPENSION / ORALABRLD, RS1993-12-16d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N019183-001CARAFATE1GM/10MLSUSPENSION / ORALABRLD, RS1993-12-1679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N019183-001CARAFATE1GM/10MLSUSPENSION / ORALABRLD, RS1993-12-16301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N019183-001CARAFATE1GM/10MLSUSPENSION / ORALABRLD, RS1993-12-161e350fbaab3a…
2024-05-31 18:47 UTC2024-05N019183-001CARAFATE1GM/10MLSUSPENSION / ORALABRLD, RS1993-12-168072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N019183-001CARAFATE1GM/10MLSUSPENSION / ORALABRLD, RS1993-12-165c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N019183-001CARAFATE1GM/10MLSUSPENSION / ORALABRLD, RS1993-12-165d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N019183-001CARAFATE1GM/10MLSUSPENSION / ORALABRLD, RS1993-12-164b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N019183-001CARAFATE1GM/10MLSUSPENSION / ORALRLD, RS1993-12-1674a2ff9319b5…
2022-03-09 01:35 UTC2022-03N019183-001CARAFATE1GM/10MLSUSPENSION / ORALABRLD, RS1993-12-16bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N019183-001CARAFATE1GM/10MLSUSPENSION / ORALABRLD, RS1993-12-16782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N019183-001CARAFATE1GM/10MLSUSPENSION / ORALABRLD, RS1993-12-1687673890dc5c…
2021-03-12 10:30 UTC2021-03N019183-001CARAFATE1GM/10MLSUSPENSION / ORALABRLD, RS1993-12-165aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N019183-001CARAFATE1GM/10MLSUSPENSION / ORALABRLD, RS1993-12-168869cabd3fbd…
2020-11-12 02:37 UTC2020-11N019183-001CARAFATE1GM/10MLSUSPENSION / ORALABRLD, RS1993-12-16c0c555d07b60…
2019-12-14 00:12 UTC2019-12N019183-001CARAFATE1GM/10MLSUSPENSION / ORALABRLD, RS1993-12-163f01610625f2…
2019-09-15 20:21 UTC2019-09N019183-001CARAFATE1GM/10MLSUSPENSION / ORALRLD, RS1993-12-16b00525d2431f…
2019-07-19 19:46 UTC2019-07N019183-001CARAFATE1GM/10MLSUSPENSION / ORALRLD, RS1993-12-16ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N019183-001CARAFATE1GM/10MLSUSPENSION / ORALABRLD, RS1993-12-166a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N019183-001CARAFATE1GM/10MLSUSPENSION / ORALABRLD, RS1993-12-161c564ffb4f44…
2023-12-20 04:57 UTC2023-12N019183-001CARAFATE1GM/10MLSUSPENSION / ORALABRLD, RS1993-12-16ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N019183-001CARAFATE1GM/10MLSUSPENSION / ORALABRLD, RS1993-12-16a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N019183-001CARAFATE1GM/10MLSUSPENSION / ORALABRLD, RS1993-12-169b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N019183-001CARAFATE1GM/10MLSUSPENSION / ORALABRLD, RS1993-12-16a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N019183-001CARAFATE1GM/10MLSUSPENSION / ORALABRLD, RS1993-12-163f0d92c62455…
2023-05-13 08:27 UTC2023-05N019183-001CARAFATE1GM/10MLSUSPENSION / ORALABRLD, RS1993-12-16053a50430f4f…
2023-01-26 05:58 UTC2023-01N019183-001CARAFATE1GM/10MLSUSPENSION / ORALABRLD, RS1993-12-163bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N019183-001CARAFATE1GM/10MLSUSPENSION / ORALABRLD, RS1993-12-163a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N019183-001CARAFATE1GM/10MLSUSPENSION / ORALABRLD, RS1993-12-16f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N019183-001CARAFATE1GM/10MLSUSPENSION / ORALABRLD, RS1993-12-16e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N019183-001CARAFATE1GM/10MLSUSPENSION / ORALABRLD, RS1993-12-16cb3db0bc1861…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02N019183-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019183-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08N019183-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019183-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019183-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019183-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019183-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019183-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N019183-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N019183-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N019183-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N019183-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N019183-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N019183-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N019183-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N019183-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N019183-001AB14b0b4de00fa7…
2022-03-09 01:35 UTC2022-03N019183-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N019183-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N019183-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03N019183-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N019183-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11N019183-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12N019183-001AB13f01610625f2…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N019183-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N019183-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12N019183-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N019183-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N019183-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N019183-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N019183-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05N019183-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01N019183-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N019183-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N019183-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N019183-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N019183-001AB1cb3db0bc1861…

Additional Listing Data#

Finished product
Yes
Brand name base
Sucralfate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SUCRALFATE1 g/10mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
XX73205DH5Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
313123Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
7407c58e-766f-4e93-a1bb-c77892ae0174Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
01e96ee1-fe82-0132-025c-ec1559bf8b6eProduct name520260127
f9fa5fa8-e047-2182-3e2c-c4a9ec6531cdProduct name320240508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82182-106-14Sucralfate420 mL in 1 BOTTLESUSPENSION4202

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
82182-106-14ML - Milliliter82182-106500c1373-c025-4274-b394-682787f9550712024-02-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82182-106SUCRALFATE SUSPENSION [PACIFIC PHARMA, INC.]1Current NDC, 1 package rows20240202_7407c58e-766f-4e93-a1bb-c77892ae0174.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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SucralfateSUCRALFATEPacific Pharma, Inc.7407c58e-766f-4e93-a1bb-c77892ae01742024-02-10Warnings, Adverse reactionsExact identifier
application applno (NDA): 019183
application number: NDA019183
ndc (package): 82182-106-14
ndc (product): 82182-106
ndc11 (package): 82182010614
CarafateSUCRALFATEAllergan, Inc.0fb67b1c-b4c0-46f2-8a81-df1510e006aa2023-06-08Warnings, Adverse reactionsExact identifier
application applno (NDA): 019183
application number: NDA019183

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313123sucralfate 1 GM in 10 mL Oral SuspensionPSN7407c58e-766f-4e93-a1bb-c77892ae01742
313123sucralfate 100 MG/ML Oral SuspensionSCD7407c58e-766f-4e93-a1bb-c77892ae01742
313123sucralfate 1 GM per 10 ML Oral SuspensionSY7407c58e-766f-4e93-a1bb-c77892ae01742

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
82182-106-1482182010614420 mL in 1 BOTTLE (82182-106-14) 420 ml2024-02-01NoNoCurrent