Lansoprazole

Product NDC
68071-2734
11-digit product format
680712734
Labeler code
68071
Product ID
68071-2734_dfdc9aa0-8613-9127-e053-2a95a90ae7c8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lansoprazole
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA203083
Marketing category
ANDA
Marketing start
2020-05-18
Marketing end
0000-00-00
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
2023-12-31
Current FDA listing
Historical FDA.report record

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 · 18 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductIInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68071-2734-6IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductIInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68071-2734-6IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductIInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68071-2734-6IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductIInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68071-2734-6IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductIInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68071-2734-6IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductIInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68071-2734-6IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductUExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68071-2734-6UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductUExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage68071-2734-6UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductUExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage68071-2734-6UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…

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
A203083-001LANSOPRAZOLELANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORALAB2020-05-18
A203083-002LANSOPRAZOLELANSOPRAZOLE30MGCAPSULE, DELAYED REL PELLETS / ORALAB2020-05-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A203083-001AB
A203083-002AB

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 2 · 74 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A203083-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORALAB2020-05-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203083-002LANSOPRAZOLE30MGCAPSULE, DELAYED REL PELLETS / ORALAB2020-05-18011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203083-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORALAB2020-05-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203083-002LANSOPRAZOLE30MGCAPSULE, DELAYED REL PELLETS / ORALAB2020-05-1831067a03dcf5…
2025-08-23 18:47 UTC2025-08A203083-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORALAB2020-05-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203083-002LANSOPRAZOLE30MGCAPSULE, DELAYED REL PELLETS / ORALAB2020-05-186a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203083-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORALAB2020-05-18fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203083-002LANSOPRAZOLE30MGCAPSULE, DELAYED REL PELLETS / ORALAB2020-05-18fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203083-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORALAB2020-05-18b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203083-002LANSOPRAZOLE30MGCAPSULE, DELAYED REL PELLETS / ORALAB2020-05-18b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203083-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORALAB2020-05-1803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203083-002LANSOPRAZOLE30MGCAPSULE, DELAYED REL PELLETS / ORALAB2020-05-1803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203083-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORALAB2020-05-182680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203083-002LANSOPRAZOLE30MGCAPSULE, DELAYED REL PELLETS / ORALAB2020-05-182680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203083-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORALAB2020-05-185bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203083-002LANSOPRAZOLE30MGCAPSULE, DELAYED REL PELLETS / ORALAB2020-05-185bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203083-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORALAB2020-05-18d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203083-002LANSOPRAZOLE30MGCAPSULE, DELAYED REL PELLETS / ORALAB2020-05-18d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A203083-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORALAB2020-05-18d06236e962d9…
2024-10-29 15:01 UTC2024-10A203083-002LANSOPRAZOLE30MGCAPSULE, DELAYED REL PELLETS / ORALAB2020-05-18d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203083-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORALAB2020-05-1879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203083-002LANSOPRAZOLE30MGCAPSULE, DELAYED REL PELLETS / ORALAB2020-05-1879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203083-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORALAB2020-05-18301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203083-002LANSOPRAZOLE30MGCAPSULE, DELAYED REL PELLETS / ORALAB2020-05-18301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203083-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORALAB2020-05-181e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203083-002LANSOPRAZOLE30MGCAPSULE, DELAYED REL PELLETS / ORALAB2020-05-181e350fbaab3a…
2024-05-31 18:47 UTC2024-05A203083-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORALAB2020-05-188072bd15b7f6…
2024-05-31 18:47 UTC2024-05A203083-002LANSOPRAZOLE30MGCAPSULE, DELAYED REL PELLETS / ORALAB2020-05-188072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203083-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORALAB2020-05-185c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203083-002LANSOPRAZOLE30MGCAPSULE, DELAYED REL PELLETS / ORALAB2020-05-185c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A203083-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORALAB2020-05-185d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A203083-002LANSOPRAZOLE30MGCAPSULE, DELAYED REL PELLETS / ORALAB2020-05-185d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A203083-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORALAB2020-05-184b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A203083-002LANSOPRAZOLE30MGCAPSULE, DELAYED REL PELLETS / ORALAB2020-05-184b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A203083-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORALAB2020-05-18bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A203083-002LANSOPRAZOLE30MGCAPSULE, DELAYED REL PELLETS / ORALAB2020-05-18bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A203083-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORALAB2020-05-18782e0a99824c…
2021-12-28 21:50 UTC2021-12A203083-002LANSOPRAZOLE30MGCAPSULE, DELAYED REL PELLETS / ORALAB2020-05-18782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A203083-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORALAB2020-05-1887673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A203083-002LANSOPRAZOLE30MGCAPSULE, DELAYED REL PELLETS / ORALAB2020-05-1887673890dc5c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 74 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A203083-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203083-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203083-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203083-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A203083-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203083-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203083-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203083-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203083-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203083-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203083-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203083-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203083-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203083-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203083-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203083-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203083-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203083-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A203083-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A203083-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203083-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203083-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203083-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203083-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203083-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203083-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A203083-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A203083-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203083-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203083-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A203083-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A203083-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A203083-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A203083-002AB14b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A203083-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A203083-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A203083-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A203083-002AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A203083-001AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A203083-002AB187673890dc5c…

Additional Listing Data#

Finished product
Yes
Brand name base
Lansoprazole
Listing expiration
2027-12-31

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
dfdc9aa0-8612-9127-e053-2a95a90ae7c8Available 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
68071-2734-6Lansoprazole60 in 1 BOTTLECAPSULE, DELAYED RELEASE601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-2734LANSOPRAZOLE CAPSULE, DELAYED RELEASE [NUCARE PHARMACEUTICALS,INC.]1Legacy NDC, 1 package rows20220526_dfdc9aa0-8612-9127-e053-2a95a90ae7c8.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 · 6 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LansoprazoleLANSOPRAZOLENuCare Pharmaceuticals,Inc.dfdc9aa0-8612-9127-e053-2a95a90ae7c82026-07-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203083
application number: ANDA203083
ndc (product): 68071-2734
LansoprazoleLANSOPRAZOLEQuallent Pharmaceuticals Health LLCcc006372-32d3-4539-921a-6bc9ec496b282025-02-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203083
application number: ANDA203083
LansoprazoleLANSOPRAZOLENuCare Pharmaceuticals,Inc.1bbb8f3a-80bf-b881-e063-6294a90ab4f22025-01-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203083
application number: ANDA203083
LansoprazoleLANSOPRAZOLEBryant Ranch Prepack33fc642c-ad41-410b-9a81-eae456f3fcfb2023-04-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203083
application number: ANDA203083
LansoprazoleLANSOPRAZOLEBryant Ranch Prepack551ae468-1a2d-43d6-a2a8-4e5f26e0f9822023-04-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203083
application number: ANDA203083
LansoprazoleLANSOPRAZOLECamber Pharmaceuticals, Inc.03b7dceb-2128-4324-b068-7f76a2d9887e2020-06-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203083
application number: ANDA203083

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
596843lansoprazole 15 MG Delayed Release Oral CapsulePSNdfdc9aa0-8612-9127-e053-2a95a90ae7c81
596843lansoprazole 15 MG Delayed Release Oral CapsuleSCDdfdc9aa0-8612-9127-e053-2a95a90ae7c81

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68071-2734-16807127340114 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68071-2734-1)2026-07-010Current
68071-2734-66807127340660 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68071-2734-6) 2022-05-250000-00-00NoNoCurrent