Home NDC 64380-149 sucralfate
Product NDC 64380-149
11-digit product format 643800149
Labeler code 64380
Product ID 64380-149_a60083fe-4fc9-444d-a210-184ca92a4716
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Sucralfate
Dosage form SUSPENSION
Route ORAL
Labeler Strides Pharma Science Limited
Application ANDA216474
Marketing category ANDA
Marketing start 2024-07-10
Substance SUCRALFATE
Active strength 1 g/10mL
Pharmacologic classes Aluminum Complex [EPC], Organometallic Compounds [CS]
NDC exclude flag No
Listing certified through 2027-12-31
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A216474-001 SUCRALFATE SUCRALFATE 1GM/10ML SUSPENSION / ORAL AB 2024-05-21
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A216474-001 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 2026-02-19 14:30 UTC 2026-02 A216474-001 SUCRALFATE 1GM/10ML SUSPENSION / ORAL AB 2024-05-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216474-001 SUCRALFATE 1GM/10ML SUSPENSION / ORAL AB 2024-05-21 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A216474-001 SUCRALFATE 1GM/10ML SUSPENSION / ORAL AB 2024-05-21 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216474-001 SUCRALFATE 1GM/10ML SUSPENSION / ORAL AB 2024-05-21 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216474-001 SUCRALFATE 1GM/10ML SUSPENSION / ORAL AB 2024-05-21 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216474-001 SUCRALFATE 1GM/10ML SUSPENSION / ORAL AB 2024-05-21 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A216474-001 SUCRALFATE 1GM/10ML SUSPENSION / ORAL AB 2024-05-21 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A216474-001 SUCRALFATE 1GM/10ML SUSPENSION / ORAL AB 2024-05-21 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A216474-001 SUCRALFATE 1GM/10ML SUSPENSION / ORAL AB 2024-05-21 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A216474-001 SUCRALFATE 1GM/10ML SUSPENSION / ORAL AB 2024-05-21 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A216474-001 SUCRALFATE 1GM/10ML SUSPENSION / ORAL AB 2024-05-21 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A216474-001 SUCRALFATE 1GM/10ML SUSPENSION / ORAL AB 2024-05-21 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A216474-001 SUCRALFATE 1GM/10ML SUSPENSION / ORAL AB 2024-05-21 1e350fbaab3a…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A216474-001 SUCRALFATE 1GM/10ML SUSPENSION / ORAL AB 2024-05-21 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base sucralfate
Listing expiration 2027-12-31 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# DailyMed Package Descriptions# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 64380-149 SUCRALFATE SUSPENSION [STRIDES PHARMA SCIENCE LIMITED] 5 Current NDC, 11 package rows 20250316_8e25bff2-769e-4bd4-a6de-895c58b840d2.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 · 3 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 64380-149-01 64380014901 420 mL in 1 BOTTLE, PLASTIC (64380-149-01) 420 ml 2024-07-10 No No Current 64380-149-02 64380014902 10 mL in 1 CUP, UNIT-DOSE 10 ml Historical 64380-149-03 64380014903 5 CUP, UNIT-DOSE in 1 TRAY (64380-149-03) / 10 mL in 1 CUP, UNIT-DOSE (64380-149-02) 2024-07-10 No No Current 64380-149-04 64380014904 3 TRAY in 1 CARTON (64380-149-04) / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE (64380-149-02) 3 tray 2024-07-10 No No Current 64380-149-05 64380014905 4 TRAY in 1 CARTON (64380-149-05) / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE (64380-149-02) 4 tray 2024-07-10 No No Current 64380-149-06 64380014906 5 TRAY in 1 CARTON (64380-149-06) / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE (64380-149-02) 5 tray 2024-07-10 No No Current 64380-149-07 64380014907 10 TRAY in 1 CARTON (64380-149-07) / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE (64380-149-02) 10 tray 2024-07-10 No No Current