Lansoprazole

Product NDC
71335-0058
11-digit product format
713350058
Labeler code
71335
Product ID
71335-0058_b565e019-9796-48dc-ab9e-6c939bd7c08c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
lansoprazole
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA091269
Marketing category
ANDA
Marketing start
2010-10-15
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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A091269-001LANSOPRAZOLELANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORALAB2010-10-15
A091269-002LANSOPRAZOLELANSOPRAZOLE30MGCAPSULE, DELAYED REL PELLETS / ORALAB2010-10-15

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A091269-001AB
A091269-002AB

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 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A091269-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORALAB2010-10-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091269-002LANSOPRAZOLE30MGCAPSULE, DELAYED REL PELLETS / ORALAB2010-10-15011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091269-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORALAB2010-10-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091269-002LANSOPRAZOLE30MGCAPSULE, DELAYED REL PELLETS / ORALAB2010-10-1531067a03dcf5…
2025-08-23 18:47 UTC2025-08A091269-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORALAB2010-10-156a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091269-002LANSOPRAZOLE30MGCAPSULE, DELAYED REL PELLETS / ORALAB2010-10-156a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091269-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORALAB2010-10-15fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091269-002LANSOPRAZOLE30MGCAPSULE, DELAYED REL PELLETS / ORALAB2010-10-15fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091269-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORALAB2010-10-15b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091269-002LANSOPRAZOLE30MGCAPSULE, DELAYED REL PELLETS / ORALAB2010-10-15b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091269-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORALAB2010-10-1503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091269-002LANSOPRAZOLE30MGCAPSULE, DELAYED REL PELLETS / ORALAB2010-10-1503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091269-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORALAB2010-10-152680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091269-002LANSOPRAZOLE30MGCAPSULE, DELAYED REL PELLETS / ORALAB2010-10-152680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091269-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORALAB2010-10-155bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091269-002LANSOPRAZOLE30MGCAPSULE, DELAYED REL PELLETS / ORALAB2010-10-155bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091269-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORALAB2010-10-15d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091269-002LANSOPRAZOLE30MGCAPSULE, DELAYED REL PELLETS / ORALAB2010-10-15d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A091269-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORALAB2010-10-15d06236e962d9…
2024-10-29 15:01 UTC2024-10A091269-002LANSOPRAZOLE30MGCAPSULE, DELAYED REL PELLETS / ORALAB2010-10-15d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091269-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORALAB2010-10-1579d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091269-002LANSOPRAZOLE30MGCAPSULE, DELAYED REL PELLETS / ORALAB2010-10-1579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091269-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORALAB2010-10-15301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091269-002LANSOPRAZOLE30MGCAPSULE, DELAYED REL PELLETS / ORALAB2010-10-15301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091269-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORALAB2010-10-151e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091269-002LANSOPRAZOLE30MGCAPSULE, DELAYED REL PELLETS / ORALAB2010-10-151e350fbaab3a…
2024-05-31 18:47 UTC2024-05A091269-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORALAB2010-10-158072bd15b7f6…
2024-05-31 18:47 UTC2024-05A091269-002LANSOPRAZOLE30MGCAPSULE, DELAYED REL PELLETS / ORALAB2010-10-158072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A091269-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORALAB2010-10-155c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A091269-002LANSOPRAZOLE30MGCAPSULE, DELAYED REL PELLETS / ORALAB2010-10-155c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A091269-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORALAB2010-10-155d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A091269-002LANSOPRAZOLE30MGCAPSULE, DELAYED REL PELLETS / ORALAB2010-10-155d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A091269-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORALAB2010-10-154b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A091269-002LANSOPRAZOLE30MGCAPSULE, DELAYED REL PELLETS / ORALAB2010-10-154b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A091269-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORALAB2010-10-1574a2ff9319b5…
2019-12-13 00:20 UTC2019-12A091269-002LANSOPRAZOLE30MGCAPSULE, DELAYED REL PELLETS / ORALAB2010-10-1574a2ff9319b5…
2022-03-09 01:35 UTC2022-03A091269-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORALAB2010-10-15bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A091269-002LANSOPRAZOLE30MGCAPSULE, DELAYED REL PELLETS / ORALAB2010-10-15bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A091269-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORALAB2010-10-15782e0a99824c…
2021-12-28 21:50 UTC2021-12A091269-002LANSOPRAZOLE30MGCAPSULE, DELAYED REL PELLETS / ORALAB2010-10-15782e0a99824c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A091269-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091269-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091269-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091269-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A091269-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091269-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091269-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091269-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091269-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091269-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091269-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091269-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091269-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091269-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091269-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091269-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091269-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091269-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A091269-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A091269-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091269-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091269-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091269-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091269-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091269-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091269-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A091269-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A091269-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A091269-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A091269-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A091269-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A091269-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A091269-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A091269-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A091269-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A091269-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A091269-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A091269-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A091269-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A091269-002AB1782e0a99824c…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LANSOPRAZOLE15 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
596843Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
e07c7445-9652-4833-8b17-45c0124c4e5dAvailable 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
71335-0058-1Lansoprazole30 in 1 BOTTLECAPSULE, DELAYED RELEASE3018
71335-0058-2Lansoprazole90 in 1 BOTTLECAPSULE, DELAYED RELEASE9018
71335-0058-3Lansoprazole60 in 1 BOTTLECAPSULE, DELAYED RELEASE6018
71335-0058-4Lansoprazole58 in 1 BOTTLECAPSULE, DELAYED RELEASE5818
71335-0058-5Lansoprazole28 in 1 BOTTLECAPSULE, DELAYED RELEASE2818
71335-0058-6Lansoprazole14 in 1 BOTTLECAPSULE, DELAYED RELEASE1418
71335-0058-7Lansoprazole120 in 1 BOTTLECAPSULE, DELAYED RELEASE12018
71335-0058-8Lansoprazole180 in 1 BOTTLECAPSULE, DELAYED RELEASE18018

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-0058-3EA - Each71335-005841f25b1e-279e-4e34-8510-0bf68dad54d112025-08-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0058LANSOPRAZOLE CAPSULE, DELAYED RELEASE [BRYANT RANCH PREPACK]18Current NDC, Legacy NDC, 8 package rows20240821_e07c7445-9652-4833-8b17-45c0124c4e5d.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 · 13 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LansoprazoleLANSOPRAZOLERedpharm Drug56cafcf5-ce3d-a312-e063-6294a90a3db12026-07-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091269
application number: ANDA091269
LansoprazoleLANSOPRAZOLEMajor Pharmaceuticals854e4235-4815-4461-9b9b-d3d783fb775d2026-03-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091269
application number: ANDA091269
LansoprazoleLANSOPRAZOLEPreferred Pharmaceuticals Inc.960d6601-aec5-4900-a400-385b6687a4bc2026-01-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091269
application number: ANDA091269
LansoprazoleLANSOPRAZOLEBryant Ranch Prepacke7a3aa37-9c9b-43fe-92be-6e0fdc8d1c922025-10-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091269
application number: ANDA091269
LansoprazoleLANSOPRAZOLEAmerican Health Packagingdee80a19-e514-41e6-9153-c959699d97b12025-01-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091269
application number: ANDA091269
Lansoprazole DRLANSOPRAZOLEAdvanced Rx Pharmacy of Tennessee, LLCc77da981-9260-fabd-e053-2a95a90aa71c2024-12-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091269
application number: ANDA091269
LansoprazoleLANSOPRAZOLENuCare Pharmaceuticals,Inc.22f416bf-00f1-ceb9-e063-6394a90aa1dd2024-09-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091269
application number: ANDA091269
LansoprazoleLANSOPRAZOLEBryant Ranch Prepacke07c7445-9652-4833-8b17-45c0124c4e5d2024-08-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091269
application number: ANDA091269
ndc (product): 71335-0058
LansoprazoleLANSOPRAZOLENuCare Pharmaceuticals,Inc.6d81faf7-aa59-429c-e053-2a91aa0a8bb22024-06-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091269
application number: ANDA091269
LansoprazoleLANSOPRAZOLEA-S Medication Solutions12b2e59b-2b7a-4d22-ad9b-9a7d9a5264bd2023-11-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091269
application number: ANDA091269
LansoprazoleLANSOPRAZOLEProficient Rx LP3e3e63df-e2ad-420b-acb9-28e65ea6fb072022-10-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091269
application number: ANDA091269
LansoprazoleLANSOPRAZOLEBluePoint Laboratories924c5a35-4804-4e14-a2fc-2b84d186d2572022-06-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091269
application number: ANDA091269
LansoprazoleLANSOPRAZOLEDr.Reddy's Laboratories Ltd.82174fcc-1b0f-2068-7fc4-db335b43b5e22022-03-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091269
application number: ANDA091269

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
596843lansoprazole 15 MG Delayed Release Oral CapsulePSNe07c7445-9652-4833-8b17-45c0124c4e5d18
596843lansoprazole 15 MG Delayed Release Oral CapsuleSCDe07c7445-9652-4833-8b17-45c0124c4e5d18

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-0058-17133500580130 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-0058-1) 2018-08-020000-00-00NoNoCurrent
71335-0058-27133500580290 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-0058-2) 2020-12-110000-00-00NoNoCurrent
71335-0058-37133500580360 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-0058-3) 2018-04-110000-00-00NoNoCurrent
71335-0058-47133500580458 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-0058-4) 2022-06-280000-00-00NoNoCurrent
71335-0058-57133500580528 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-0058-5) 2022-06-280000-00-00NoNoCurrent
71335-0058-67133500580614 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-0058-6) 2019-12-100000-00-00NoNoCurrent
71335-0058-771335005807120 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-0058-7) 2022-06-280000-00-00NoNoCurrent
71335-0058-871335005808180 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-0058-8) 2022-06-280000-00-00NoNoCurrent