Lansoprazole

Product NDC
68071-4456
11-digit product format
680714456
Labeler code
68071
Product ID
68071-4456_1a8d53cc-6fe3-1474-e063-6394a90a7951
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
lansoprazole
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
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

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage68071-4456-6557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage68071-4456-68af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage68071-4456-6834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage68071-4456-61332a3947898…d4bfe170f9cd…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage68071-4456-6e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage68071-4456-69bebd1f3094a…5416666fcb17…

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
6d81faf7-aa59-429c-e053-2a91aa0a8bb2Available 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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-4456-6Lansoprazole60 in 1 BOTTLECAPSULE, DELAYED RELEASE604

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-4456LANSOPRAZOLE CAPSULE, DELAYED RELEASE [NUCARE PHARMACEUTICALS,INC.]4Current NDC, Legacy NDC, 1 package rows20240822_6d81faf7-aa59-429c-e053-2a91aa0a8bb2.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
LansoprazoleLANSOPRAZOLENuCare Pharmaceuticals,Inc.6d81faf7-aa59-429c-e053-2a91aa0a8bb22024-06-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091269
application number: ANDA091269
ndc (product): 68071-4456
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 CapsulePSN6d81faf7-aa59-429c-e053-2a91aa0a8bb24
596843lansoprazole 15 MG Delayed Release Oral CapsuleSCD6d81faf7-aa59-429c-e053-2a91aa0a8bb24

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68071-4456-66807144560660 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68071-4456-6) 2018-05-310000-00-00NoNoCurrent