Home NDC 33342-310 Lansoprazole
Product NDC 33342-310
11-digit product format 333420310
Labeler code 33342
Product ID 33342-310_75691c2d-2265-4153-bc3a-4f7d5d51e250
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Lansoprazole
Dosage form CAPSULE, DELAYED RELEASE
Route ORAL
Labeler Macleods Pharmaceuticals Limited
Application ANDA208671
Marketing category ANDA
Marketing start 2024-11-05
Substance LANSOPRAZOLE
Active strength 15 mg/1
Pharmacologic classes Inhibition Gastric Acid Secretion [PE], 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 1 .
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 A208671-001 LANSOPRAZOLE LANSOPRAZOLE 15MG CAPSULE, DELAYED REL PELLETS / ORAL 2024-11-04 A208671-002 LANSOPRAZOLE LANSOPRAZOLE 30MG CAPSULE, DELAYED REL PELLETS / ORAL 2024-11-04
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 A208671-001 LANSOPRAZOLE 15MG CAPSULE, DELAYED REL PELLETS / ORAL 2024-11-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A208671-002 LANSOPRAZOLE 30MG CAPSULE, DELAYED REL PELLETS / ORAL 2024-11-04 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208671-001 LANSOPRAZOLE 15MG CAPSULE, DELAYED REL PELLETS / ORAL 2024-11-04 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208671-002 LANSOPRAZOLE 30MG CAPSULE, DELAYED REL PELLETS / ORAL 2024-11-04 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A208671-001 LANSOPRAZOLE 15MG CAPSULE, DELAYED REL PELLETS / ORAL 2024-11-04 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A208671-002 LANSOPRAZOLE 30MG CAPSULE, DELAYED REL PELLETS / ORAL 2024-11-04 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208671-001 LANSOPRAZOLE 15MG CAPSULE, DELAYED REL PELLETS / ORAL AB 2024-11-04 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208671-002 LANSOPRAZOLE 30MG CAPSULE, DELAYED REL PELLETS / ORAL AB 2024-11-04 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208671-001 LANSOPRAZOLE 15MG CAPSULE, DELAYED REL PELLETS / ORAL AB 2024-11-04 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208671-002 LANSOPRAZOLE 30MG CAPSULE, DELAYED REL PELLETS / ORAL AB 2024-11-04 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208671-001 LANSOPRAZOLE 15MG CAPSULE, DELAYED REL PELLETS / ORAL AB 2024-11-04 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208671-002 LANSOPRAZOLE 30MG CAPSULE, DELAYED REL PELLETS / ORAL AB 2024-11-04 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208671-001 LANSOPRAZOLE 15MG CAPSULE, DELAYED REL PELLETS / ORAL AB 2024-11-04 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208671-002 LANSOPRAZOLE 30MG CAPSULE, DELAYED REL PELLETS / ORAL AB 2024-11-04 2680178bc6a6…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A208671-001 LANSOPRAZOLE 15MG CAPSULE, DELAYED REL PELLETS / ORAL AB 2024-11-04 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A208671-002 LANSOPRAZOLE 30MG CAPSULE, DELAYED REL PELLETS / ORAL AB 2024-11-04 d8e5a09893c0…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A208671-001 LANSOPRAZOLE 15MG CAPSULE, DELAYED REL PELLETS / ORAL 2024-11-04 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A208671-002 LANSOPRAZOLE 30MG CAPSULE, DELAYED REL PELLETS / ORAL 2024-11-04 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Lansoprazole
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LANSOPRAZOLE 15 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 0K5C5T2QPG Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 311277 Internal RxNorm lookup 596843 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 33342-310-07 Lansoprazole 30 in 1 BOTTLE CAPSULE, DELAYED RELEASE 30 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 33342-310 LANSOPRAZOLE CAPSULE, DELAYED RELEASE [MACLEODS PHARMACEUTICALS LIMITED] 1 Current NDC, 1 package rows 20241204_75691c2d-2265-4153-bc3a-4f7d5d51e250.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 · 1 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 33342-310-07 33342031007 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (33342-310-07) 2024-11-05 No No Current