Lansoprazole

Product NDC
71335-1425
11-digit product format
713351425
Labeler code
71335
Product ID
71335-1425_40271c8f-06d7-42c1-a983-8d49f0205268
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lansoprazole
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA205868
Marketing category
ANDA
Marketing start
2018-06-04
Substance
LANSOPRAZOLE
Active strength
30 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 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
A205868-001LANSOPRAZOLELANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORALAB2017-08-30
A205868-002LANSOPRAZOLELANSOPRAZOLE30MGCAPSULE, DELAYED REL PELLETS / ORALAB2017-08-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A205868-001AB
A205868-002AB

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 22:38:342026-08A205868-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORALAB2017-08-3084e616aacf4f…
2026-09-14 22:38:342026-08A205868-002LANSOPRAZOLE30MGCAPSULE, DELAYED REL PELLETS / ORALAB2017-08-3084e616aacf4f…
2026-08-18 06:07:402026-07A205868-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORALAB2017-08-30caaa826d4ba7…
2026-08-18 06:07:402026-07A205868-002LANSOPRAZOLE30MGCAPSULE, DELAYED REL PELLETS / ORALAB2017-08-30caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A205868-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORALAB2017-08-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02A205868-002LANSOPRAZOLE30MGCAPSULE, DELAYED REL PELLETS / ORALAB2017-08-30011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205868-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORALAB2017-08-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205868-002LANSOPRAZOLE30MGCAPSULE, DELAYED REL PELLETS / ORALAB2017-08-3031067a03dcf5…
2025-08-23 18:47 UTC2025-08A205868-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORALAB2017-08-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205868-002LANSOPRAZOLE30MGCAPSULE, DELAYED REL PELLETS / ORALAB2017-08-306a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205868-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORALAB2017-08-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205868-002LANSOPRAZOLE30MGCAPSULE, DELAYED REL PELLETS / ORALAB2017-08-30fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205868-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORALAB2017-08-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205868-002LANSOPRAZOLE30MGCAPSULE, DELAYED REL PELLETS / ORALAB2017-08-30b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205868-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORALAB2017-08-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205868-002LANSOPRAZOLE30MGCAPSULE, DELAYED REL PELLETS / ORALAB2017-08-3003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205868-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORALAB2017-08-302680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205868-002LANSOPRAZOLE30MGCAPSULE, DELAYED REL PELLETS / ORALAB2017-08-302680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205868-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORALAB2017-08-305bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205868-002LANSOPRAZOLE30MGCAPSULE, DELAYED REL PELLETS / ORALAB2017-08-305bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205868-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORALAB2017-08-30d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205868-002LANSOPRAZOLE30MGCAPSULE, DELAYED REL PELLETS / ORALAB2017-08-30d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A205868-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORALAB2017-08-30d06236e962d9…
2024-10-29 15:01 UTC2024-10A205868-002LANSOPRAZOLE30MGCAPSULE, DELAYED REL PELLETS / ORALAB2017-08-30d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A205868-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORALAB2017-08-3079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A205868-002LANSOPRAZOLE30MGCAPSULE, DELAYED REL PELLETS / ORALAB2017-08-3079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A205868-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORALAB2017-08-30301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A205868-002LANSOPRAZOLE30MGCAPSULE, DELAYED REL PELLETS / ORALAB2017-08-30301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A205868-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORALAB2017-08-301e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A205868-002LANSOPRAZOLE30MGCAPSULE, DELAYED REL PELLETS / ORALAB2017-08-301e350fbaab3a…
2024-05-31 18:47 UTC2024-05A205868-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORALAB2017-08-308072bd15b7f6…
2024-05-31 18:47 UTC2024-05A205868-002LANSOPRAZOLE30MGCAPSULE, DELAYED REL PELLETS / ORALAB2017-08-308072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A205868-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORALAB2017-08-305c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A205868-002LANSOPRAZOLE30MGCAPSULE, DELAYED REL PELLETS / ORALAB2017-08-305c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A205868-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORALAB2017-08-305d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A205868-002LANSOPRAZOLE30MGCAPSULE, DELAYED REL PELLETS / ORALAB2017-08-305d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A205868-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORALAB2017-08-304b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A205868-002LANSOPRAZOLE30MGCAPSULE, DELAYED REL PELLETS / ORALAB2017-08-304b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A205868-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORALAB2017-08-3074a2ff9319b5…
2019-12-13 00:20 UTC2019-12A205868-002LANSOPRAZOLE30MGCAPSULE, DELAYED REL PELLETS / ORALAB2017-08-3074a2ff9319b5…

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 22:38:342026-08A205868-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A205868-002AB184e616aacf4f…
2026-08-18 06:07:402026-07A205868-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A205868-002AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A205868-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A205868-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205868-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205868-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A205868-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205868-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205868-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205868-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205868-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205868-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205868-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205868-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205868-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205868-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205868-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205868-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205868-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205868-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A205868-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A205868-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A205868-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A205868-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A205868-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A205868-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A205868-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A205868-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A205868-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A205868-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A205868-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A205868-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A205868-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A205868-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A205868-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A205868-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A205868-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A205868-002AB174a2ff9319b5…

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LANSOPRAZOLE30 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
0K5C5T2QPGInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
311277Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
8f0d3f2f-91d9-467a-a841-540664af80f9Available on FDA.report

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
71335-1425-1Lansoprazole30 in 1 BOTTLECAPSULE, DELAYED RELEASE306
71335-1425-2Lansoprazole90 in 1 BOTTLECAPSULE, DELAYED RELEASE906
71335-1425-3Lansoprazole18 in 1 BOTTLECAPSULE, DELAYED RELEASE186
71335-1425-4Lansoprazole28 in 1 BOTTLECAPSULE, DELAYED RELEASE286
71335-1425-5Lansoprazole56 in 1 BOTTLECAPSULE, DELAYED RELEASE566
71335-1425-6Lansoprazole58 in 1 BOTTLECAPSULE, DELAYED RELEASE586
71335-1425-7Lansoprazole60 in 1 BOTTLECAPSULE, DELAYED RELEASE606
71335-1425-8Lansoprazole180 in 1 BOTTLECAPSULE, DELAYED RELEASE1806
71335-1425-9Lansoprazole120 in 1 BOTTLECAPSULE, DELAYED RELEASE1206

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-1425-1EA - Each71335-14255e326d1f-1e45-463b-b572-704c3f94467612023-12-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1425LANSOPRAZOLE CAPSULE, DELAYED RELEASE [BRYANT RANCH PREPACK]6Current NDC, Legacy NDC, 9 package rows20240828_8f0d3f2f-91d9-467a-a841-540664af80f9.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 · 9 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LansoprazoleLANSOPRAZOLEPreferred Pharmaceuticals, Inc.7286d6a5-611b-4993-ab93-4899d599435d2026-05-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205868
application number: ANDA205868
LansoprazoleLANSOPRAZOLENuCare Pharmaceuticals,Inc.1c364fc5-eb43-b12f-e063-6294a90a43192025-01-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205868
application number: ANDA205868
Lansoprazole DRLANSOPRAZOLEAdvanced Rx Pharmacy of Tennessee, LLCce1a4f32-da65-29d3-e053-2995a90a42ee2024-12-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205868
application number: ANDA205868
LansoprazoleLANSOPRAZOLEBryant Ranch Prepack8f0d3f2f-91d9-467a-a841-540664af80f92024-08-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205868
application number: ANDA205868
ndc (product): 71335-1425
Lansoprazole DRLANSOPRAZOLE DRDirect_Rxe5bcfc5b-f5a9-3260-e053-2a95a90ab70e2024-08-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205868
application number: ANDA205868
LansoprazoleLANSOPRAZOLENuCare Pharmaceuticals,Inc.b12cca1c-da28-67e2-e053-2a95a90aaf6b2024-07-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205868
application number: ANDA205868
LansoprazoleLANSOPRAZOLENuCare Pharmaceuticals,Inc.9a277b9e-2e13-27c3-e053-2995a90a7ed52024-06-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205868
application number: ANDA205868
LansoprazoleLANSOPRAZOLEA-S Medication Solutions495d3ca8-d37d-440a-80ce-9342d9ff281a2023-11-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205868
application number: ANDA205868
LansoprazoleLANSOPRAZOLELifestar Pharma LLC.afcc0f14-8b00-41ac-8e62-4094a15b959c2022-03-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205868
application number: ANDA205868

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311277lansoprazole 30 MG Delayed Release Oral CapsulePSN8f0d3f2f-91d9-467a-a841-540664af80f96
311277lansoprazole 30 MG Delayed Release Oral CapsuleSCD8f0d3f2f-91d9-467a-a841-540664af80f96

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-1425-17133514250130 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-1425-1) 2019-12-040000-00-00NoNoCurrent
71335-1425-27133514250290 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-1425-2) 2020-11-060000-00-00NoNoCurrent
71335-1425-37133514250318 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-1425-3) 2022-05-020000-00-00NoNoCurrent
71335-1425-47133514250428 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-1425-4) 2022-05-020000-00-00NoNoCurrent
71335-1425-57133514250556 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-1425-5) 2022-05-020000-00-00NoNoCurrent
71335-1425-67133514250658 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-1425-6) 2022-05-020000-00-00NoNoCurrent
71335-1425-77133514250760 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-1425-7) 2020-09-290000-00-00NoNoCurrent
71335-1425-871335142508180 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-1425-8) 2022-05-020000-00-00NoNoCurrent
71335-1425-971335142509120 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-1425-9) 2022-05-020000-00-00NoNoCurrent