LANSOPRAZOLE DELAYED-RELEASE ORALLY DISINTEGRATING TABLETS

Manufacturer
Zydus Lifesciences Limited
Effective date
2024-11-30
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-05-31 21:18:34

Label at a glance#

ProductLANSOPRAZOLE
Active ingredientLANSOPRAZOLE
Label structure1 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1132-4

Lansoprazole Delayed-release Orally Disintegrating Tablets, 15 mg

Rx only

100 Tablets (10 x 10 Unit Dose)

Lansoprazole delayed-release orally disintegrating tablets, 15 mg
Lansoprazole delayed-release orally disintegrating tablets, 15 mg

NDC 70771-1133-4

Lansoprazole Delayed-release Orally Disintegrating Tablets, 30 mg

Rx only

100 Tablets (10 x 10 Unit Dose)

Lansoprazole delayed-release orally disintegrating tablets, 30 mg
Lansoprazole delayed-release orally disintegrating tablets, 30 mg

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
351261lansoprazole 15 MG Delayed Release Disintegrating Oral TabletPSN6
351260lansoprazole 30 MG Delayed Release Disintegrating Oral TabletPSN6
351261lansoprazole 15 MG Disintegrating Oral TabletSCD6
351260lansoprazole 30 MG Disintegrating Oral TabletSCD6
351261lansoprazole 15 MG Delayed Release Disintegrating Oral TabletSY6
351260lansoprazole 30 MG Delayed Release Disintegrating Oral TabletSY6

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
LANSOPRAZOLE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d6b97638-59f4-48e2-8959-569628732c46Product name920210622
8690a824-4bf8-4d1e-b118-2d6dda86bc04Product name220161206

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70771-1132-4LANSOPRAZOLE10 in 1 CARTONTABLET, ORALLY DISINTEGRATING106
70771-1132-4LANSOPRAZOLE10 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING106
70771-1133-4LANSOPRAZOLE10 in 1 CARTONTABLET, ORALLY DISINTEGRATING106
70771-1133-4LANSOPRAZOLE10 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING106

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70771-1132LANSOPRAZOLE TABLET, ORALLY DISINTEGRATING [ZYDUS LIFESCIENCES LIMITED]6Current NDC, Legacy NDC, 2 package rows20241204_76ffd38e-bea8-45a0-b6bd-82f0043ce64d.zip
70771-1133LANSOPRAZOLE TABLET, ORALLY DISINTEGRATING [ZYDUS LIFESCIENCES LIMITED]6Current NDC, Legacy NDC, 2 package rows20241204_76ffd38e-bea8-45a0-b6bd-82f0043ce64d.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 24 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70771-113270771-1132-4
70771-113370771-1133-4

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 2 · 48 matching rows.

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A200816-001LANSOPRAZOLELANSOPRAZOLE15MGTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORALAB2018-11-27
A200816-002LANSOPRAZOLELANSOPRAZOLE30MGTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORALAB2018-11-27

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A200816-001AB
A200816-002AB

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 3 · 86 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A200816-001LANSOPRAZOLE15MGTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORALAB2018-11-2784e616aacf4f…
2026-09-14 22:38:342026-08A200816-002LANSOPRAZOLE30MGTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORALAB2018-11-2784e616aacf4f…
2026-08-18 06:07:402026-07A200816-001LANSOPRAZOLE15MGTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORALAB2018-11-27caaa826d4ba7…
2026-08-18 06:07:402026-07A200816-002LANSOPRAZOLE30MGTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORALAB2018-11-27caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A200816-001LANSOPRAZOLE15MGTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORALAB2018-11-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A200816-002LANSOPRAZOLE30MGTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORALAB2018-11-27011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A200816-001LANSOPRAZOLE15MGTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORALAB2018-11-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A200816-002LANSOPRAZOLE30MGTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORALAB2018-11-2731067a03dcf5…
2025-08-23 18:47 UTC2025-08A200816-001LANSOPRAZOLE15MGTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORALAB2018-11-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A200816-002LANSOPRAZOLE30MGTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORALAB2018-11-276a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A200816-001LANSOPRAZOLE15MGTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORALAB2018-11-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A200816-002LANSOPRAZOLE30MGTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORALAB2018-11-27fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A200816-001LANSOPRAZOLE15MGTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORALAB2018-11-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A200816-002LANSOPRAZOLE30MGTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORALAB2018-11-27b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A200816-001LANSOPRAZOLE15MGTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORALAB2018-11-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A200816-002LANSOPRAZOLE30MGTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORALAB2018-11-2703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A200816-001LANSOPRAZOLE15MGTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORALAB2018-11-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A200816-002LANSOPRAZOLE30MGTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORALAB2018-11-272680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A200816-001LANSOPRAZOLE15MGTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORALAB2018-11-275bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A200816-002LANSOPRAZOLE30MGTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORALAB2018-11-275bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A200816-001LANSOPRAZOLE15MGTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORALAB2018-11-27d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A200816-002LANSOPRAZOLE30MGTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORALAB2018-11-27d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A200816-001LANSOPRAZOLE15MGTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORALAB2018-11-27d06236e962d9…
2024-10-29 15:01 UTC2024-10A200816-002LANSOPRAZOLE30MGTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORALAB2018-11-27d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A200816-001LANSOPRAZOLE15MGTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORALAB2018-11-2779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A200816-002LANSOPRAZOLE30MGTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORALAB2018-11-2779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A200816-001LANSOPRAZOLE15MGTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORALAB2018-11-27301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A200816-002LANSOPRAZOLE30MGTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORALAB2018-11-27301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A200816-001LANSOPRAZOLE15MGTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORALAB2018-11-271e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A200816-002LANSOPRAZOLE30MGTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORALAB2018-11-271e350fbaab3a…
2024-05-31 18:47 UTC2024-05A200816-001LANSOPRAZOLE15MGTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORALAB2018-11-278072bd15b7f6…
2024-05-31 18:47 UTC2024-05A200816-002LANSOPRAZOLE30MGTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORALAB2018-11-278072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A200816-001LANSOPRAZOLE15MGTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORALAB2018-11-275c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A200816-002LANSOPRAZOLE30MGTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORALAB2018-11-275c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A200816-001LANSOPRAZOLE15MGTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORALAB2018-11-275d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A200816-002LANSOPRAZOLE30MGTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORALAB2018-11-275d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A200816-001LANSOPRAZOLE15MGTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORALAB2018-11-274b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A200816-002LANSOPRAZOLE30MGTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORALAB2018-11-274b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A200816-001LANSOPRAZOLE15MGTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORALAB2018-11-2774a2ff9319b5…
2019-12-13 00:20 UTC2019-12A200816-002LANSOPRAZOLE30MGTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORALAB2018-11-2774a2ff9319b5…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A200816-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A200816-002AB184e616aacf4f…
2026-08-18 06:07:402026-07A200816-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A200816-002AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A200816-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A200816-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A200816-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A200816-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A200816-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A200816-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A200816-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A200816-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A200816-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A200816-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A200816-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A200816-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A200816-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A200816-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A200816-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A200816-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A200816-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A200816-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A200816-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A200816-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A200816-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A200816-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A200816-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A200816-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A200816-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A200816-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A200816-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A200816-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A200816-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A200816-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A200816-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A200816-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A200816-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A200816-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A200816-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A200816-002AB174a2ff9319b5…

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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LANSOPRAZOLELANSOPRAZOLEZydus Lifesciences Limited76ffd38e-bea8-45a0-b6bd-82f0043ce64d2024-11-30Exact identifier
ndc (package): 70771-1132-4
ndc (package): 70771-1133-4
ndc (product): 70771-1132
ndc (product): 70771-1133
ndc11 (package): 70771113204
ndc11 (package): 70771113304
spl id: 05217d4a-ad65-460c-b041-e17fda6eec59
spl set id: 76ffd38e-bea8-45a0-b6bd-82f0043ce64d

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.