Home NDC 62332-823 Dexlansoprazole
Product NDC 62332-823
11-digit product format 623320823
Labeler code 62332
Product ID 62332-823_c75e1427-f24f-46ab-8a19-29069bc6ca2e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Dexlansoprazole
Dosage form CAPSULE, DELAYED RELEASE
Route ORAL
Labeler Alembic Pharmaceuticals Inc.
Application ANDA219115
Marketing category ANDA
Marketing start 2025-11-14
Substance DEXLANSOPRAZOLE
Active strength 30 mg/1
Pharmacologic classes Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]
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 43 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A219115-001 DEXLANSOPRAZOLE DEXLANSOPRAZOLE 30MG CAPSULE, DELAYED RELEASE / ORAL AB 2025-11-12 A219115-002 DEXLANSOPRAZOLE DEXLANSOPRAZOLE 60MG CAPSULE, DELAYED RELEASE / ORAL AB 2025-11-12
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 2026-09-14 22:38:34 2026-08 A219115-001 DEXLANSOPRAZOLE 30MG CAPSULE, DELAYED RELEASE / ORAL AB 2025-11-12 84e616aacf4f…2026-09-14 22:38:34 2026-08 A219115-002 DEXLANSOPRAZOLE 60MG CAPSULE, DELAYED RELEASE / ORAL AB 2025-11-12 84e616aacf4f…2026-08-18 06:07:40 2026-07 A219115-001 DEXLANSOPRAZOLE 30MG CAPSULE, DELAYED RELEASE / ORAL AB 2025-11-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A219115-002 DEXLANSOPRAZOLE 60MG CAPSULE, DELAYED RELEASE / ORAL AB 2025-11-12 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A219115-001 DEXLANSOPRAZOLE 30MG CAPSULE, DELAYED RELEASE / ORAL AB 2025-11-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A219115-002 DEXLANSOPRAZOLE 60MG CAPSULE, DELAYED RELEASE / ORAL AB 2025-11-12 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A219115-001 DEXLANSOPRAZOLE 30MG CAPSULE, DELAYED RELEASE / ORAL AB 2025-11-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A219115-002 DEXLANSOPRAZOLE 60MG CAPSULE, DELAYED RELEASE / ORAL AB 2025-11-12 31067a03dcf5…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A219115-001 DEXLANSOPRAZOLE 30MG CAPSULE, DELAYED RELEASE / ORAL AB 2025-11-12 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A219115-002 DEXLANSOPRAZOLE 60MG CAPSULE, DELAYED RELEASE / ORAL AB 2025-11-12 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Dexlansoprazole
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DEXLANSOPRAZOLE 30 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination UYE4T5I70X Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 833204 Internal RxNorm lookup 833213 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 62332-823-30 Dexlansoprazole 30 in 1 BOTTLE CAPSULE, DELAYED RELEASE 30 4 62332-823-90 Dexlansoprazole 90 in 1 BOTTLE CAPSULE, DELAYED RELEASE 90 4
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 Marketing start Sample Exclude flag Status 62332-823-30 62332082330 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (62332-823-30) 2025-11-14 No No Current 62332-823-90 62332082390 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (62332-823-90) 2025-11-14 No No Current