Lansoprazole

Product NDC
43598-109
11-digit product format
435980109
Labeler code
43598
Product ID
43598-109_12c603b4-a2cf-bfae-92c1-8b87a30e12ad
Type
HUMAN OTC DRUG
Nonproprietary name
Lansoprazole
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Dr. Reddy's Laboratories Inc.
Application
ANDA202194
Marketing category
ANDA
Marketing start
2022-04-12
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 · 42 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 21:27 UTC · source 2025-12-05unfinished productproducta6255e0c9aa5…a0211a219f2e…
2025-12-14 21:27 UTC · source 2025-12-05unfinished packagepackage43598-109-48a6255e0c9aa5…a0211a219f2e…
2025-12-14 21:27 UTC · source 2025-12-05unfinished packagepackage43598-109-94a6255e0c9aa5…a0211a219f2e…
2025-08-26 23:59 UTC · source 2025-08-26unfinished productproduct1d862106b807…00c93037cd84…
2025-08-26 23:59 UTC · source 2025-08-26unfinished packagepackage43598-109-481d862106b807…00c93037cd84…
2025-08-26 23:59 UTC · source 2025-08-26unfinished packagepackage43598-109-941d862106b807…00c93037cd84…
2025-05-15 14:59 UTC · source 2025-05-14unfinished productproduct390b4c401c3f…2c692c2daee3…
2025-05-15 14:59 UTC · source 2025-05-14unfinished packagepackage43598-109-94390b4c401c3f…2c692c2daee3…
2025-05-15 14:59 UTC · source 2025-05-14unfinished packagepackage43598-109-48390b4c401c3f…2c692c2daee3…
2025-04-01 07:37 UTC · source 2025-03-31unfinished productproducte30019b0c005…a3f0b14938b7…
2025-04-01 07:37 UTC · source 2025-03-31unfinished packagepackage43598-109-94e30019b0c005…a3f0b14938b7…
2025-04-01 07:37 UTC · source 2025-03-31unfinished packagepackage43598-109-48e30019b0c005…a3f0b14938b7…
2025-03-01 13:19 UTC · source 2025-02-28unfinished productproductbbbc9f937eca…946b9c97cf81…
2025-03-01 13:19 UTC · source 2025-02-28unfinished packagepackage43598-109-94bbbc9f937eca…946b9c97cf81…
2025-03-01 13:19 UTC · source 2025-02-28unfinished packagepackage43598-109-48bbbc9f937eca…946b9c97cf81…
2025-02-27 05:24 UTC · source 2025-02-26unfinished productproductf268b84574a6…26285f5ac5df…
2025-02-27 05:24 UTC · source 2025-02-26unfinished packagepackage43598-109-94f268b84574a6…26285f5ac5df…
2025-02-27 05:24 UTC · source 2025-02-26unfinished packagepackage43598-109-48f268b84574a6…26285f5ac5df…
2025-02-01 13:13 UTC · source 2025-01-31unfinished productproductf764e8902f78…92046438deef…
2025-02-01 13:13 UTC · source 2025-01-31unfinished packagepackage43598-109-94f764e8902f78…92046438deef…
2025-02-01 13:13 UTC · source 2025-01-31unfinished packagepackage43598-109-48f764e8902f78…92046438deef…
2025-01-20 13:05 UTC · source 2025-01-17unfinished productproduct68b1e3bced9e…98a755eb8bc6…
2025-01-20 13:05 UTC · source 2025-01-17unfinished packagepackage43598-109-9468b1e3bced9e…98a755eb8bc6…
2025-01-20 13:05 UTC · source 2025-01-17unfinished packagepackage43598-109-4868b1e3bced9e…98a755eb8bc6…
2024-11-29 20:42 UTC · source 2024-11-29unfinished productproduct05c55d027831…ca05dca9dc4c…
2024-11-29 20:42 UTC · source 2024-11-29unfinished packagepackage43598-109-9405c55d027831…ca05dca9dc4c…
2024-11-29 20:42 UTC · source 2024-11-29unfinished packagepackage43598-109-4805c55d027831…ca05dca9dc4c…
2024-11-09 02:36 UTC · source 2024-11-08unfinished productproduct48b4f40e6753…c7c7a00d2afa…
2024-11-09 02:36 UTC · source 2024-11-08unfinished packagepackage43598-109-9448b4f40e6753…c7c7a00d2afa…
2024-11-09 02:36 UTC · source 2024-11-08unfinished packagepackage43598-109-4848b4f40e6753…c7c7a00d2afa…
2024-10-09 02:27 UTC · source 2024-10-08unfinished productproduct27f29a85d7e4…1372111e901f…
2024-10-09 02:27 UTC · source 2024-10-08unfinished packagepackage43598-109-9427f29a85d7e4…1372111e901f…
2024-10-09 02:27 UTC · source 2024-10-08unfinished packagepackage43598-109-4827f29a85d7e4…1372111e901f…
2024-07-10 04:00 UTC · source 2024-07-09unfinished productproduct8d62ce987f31…9fe9ef23e30d…
2024-07-10 04:00 UTC · source 2024-07-09unfinished packagepackage43598-109-488d62ce987f31…9fe9ef23e30d…
2024-07-10 04:00 UTC · source 2024-07-09unfinished packagepackage43598-109-948d62ce987f31…9fe9ef23e30d…
2024-05-28 21:11 UTC · source 2024-05-28unfinished productproductd1e113ab4d42…063ee3eb0a1d…
2024-05-28 21:11 UTC · source 2024-05-28unfinished packagepackage43598-109-48d1e113ab4d42…063ee3eb0a1d…
2024-05-28 21:11 UTC · source 2024-05-28unfinished packagepackage43598-109-94d1e113ab4d42…063ee3eb0a1d…
2024-05-15 03:51 UTC · source 2024-05-14unfinished productproduct50b4072663b7…eae3003ed65e…
2024-05-15 03:51 UTC · source 2024-05-14unfinished packagepackage43598-109-4850b4072663b7…eae3003ed65e…
2024-05-15 03:51 UTC · source 2024-05-14unfinished packagepackage43598-109-9450b4072663b7…eae3003ed65e…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A202194-001LANSOPRAZOLELANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2012-05-18

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 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A202194-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2012-05-18011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202194-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2012-05-1831067a03dcf5…
2025-08-23 18:47 UTC2025-08A202194-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2012-05-186a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202194-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2012-05-18fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202194-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2012-05-18b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202194-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2012-05-1803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202194-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2012-05-182680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202194-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2012-05-185bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202194-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2012-05-18d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A202194-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2012-05-18d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202194-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2012-05-1879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202194-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2012-05-18301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202194-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2012-05-181e350fbaab3a…
2024-05-31 18:47 UTC2024-05A202194-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2012-05-188072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A202194-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2012-05-185c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A202194-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2012-05-185d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A202194-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2012-05-184b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A202194-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2012-05-1874a2ff9319b5…
2022-03-09 01:35 UTC2022-03A202194-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2012-05-18bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A202194-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2012-05-18782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A202194-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2012-05-1887673890dc5c…
2021-03-12 10:30 UTC2021-03A202194-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2012-05-185aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A202194-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2012-05-188869cabd3fbd…
2020-11-12 02:37 UTC2020-11A202194-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2012-05-18c0c555d07b60…
2019-12-14 00:12 UTC2019-12A202194-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2012-05-183f01610625f2…
2019-09-15 20:21 UTC2019-09A202194-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2012-05-18b00525d2431f…
2019-07-19 19:46 UTC2019-07A202194-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2012-05-18ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A202194-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2012-05-186a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A202194-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2012-05-181c564ffb4f44…
2023-12-20 04:57 UTC2023-12A202194-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2012-05-18ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A202194-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2012-05-18a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A202194-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2012-05-189b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A202194-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2012-05-18a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A202194-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2012-05-183f0d92c62455…
2023-05-13 08:27 UTC2023-05A202194-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2012-05-18053a50430f4f…
2023-01-26 05:58 UTC2023-01A202194-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2012-05-183bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A202194-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2012-05-183a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A202194-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2012-05-18f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A202194-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2012-05-18e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A202194-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2012-05-18cb3db0bc1861…

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
4a701c0d-fef5-aa12-01e6-e3680a161a7dAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
d6b97638-59f4-48e2-8959-569628732c46Product name920210622
8690a824-4bf8-4d1e-b118-2d6dda86bc04Product name220161206

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43598-109-27EA - Each43598-109e34ff52a-bbd9-49ba-a576-cfee2c09d20712024-08-12
43598-109-52EA - Each43598-1090ddb6aef-aaa4-4fa8-ad62-e92e49e8e1ed12024-08-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43598-109LANSOPRAZOLE CAPSULE, DELAYED RELEASE [DR. REDDY'S LABORATORIES INC.]7Current NDC, Legacy NDC20240727_4a701c0d-fef5-aa12-01e6-e3680a161a7d.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 · 8 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LansoprazoleLANSOPRAZOLEDr. Reddy's Laboratories Inc.4a701c0d-fef5-aa12-01e6-e3680a161a7d2026-07-21WarningsExact identifier
application applno (ANDA): 202194
application number: ANDA202194
ndc (product): 43598-109
LansoprazoleLANSOPRAZOLERugby Laboratories, Incaa95216c-8985-d160-1743-ba168a35177f2026-07-17WarningsExact identifier
application applno (ANDA): 202194
application number: ANDA202194
LansoprazoleLANSOPRAZOLEDr. Reddy's Laboratories Inc.a24acc0b-7770-1087-77bd-048259a5bf722026-07-15WarningsExact identifier
application applno (ANDA): 202194
application number: ANDA202194
LansoprazoleLANSOPRAZOLELEADER/ Cardinal Health 110, Inc.486838cd-17ee-c2df-4e05-aa6106dd8fd82026-07-15WarningsExact identifier
application applno (ANDA): 202194
application number: ANDA202194
LansoprazoleLANSOPRAZOLEDr. Reddy's Laboratories Limited15e05eda-48aa-a4b7-4b8a-4ee1cf1101202026-07-09WarningsExact identifier
application applno (ANDA): 202194
application number: ANDA202194
LansoprazoleLANSOPRAZOLEAMERISOURCEBERGEN DRUG CORPORATIONaccb92e8-dd14-b87b-c20a-6c4803815bc22026-04-17WarningsExact identifier
application applno (ANDA): 202194
application number: ANDA202194
LansoprazoleLANSOPRAZOLEChain Drug Marketing Association74417c65-cccd-5a6a-0f96-0d8cb5a1592a2025-07-18WarningsExact identifier
application applno (ANDA): 202194
application number: ANDA202194
LansoprazoleLANSOPRAZOLEWalgreens company277093d5-cd0f-36ad-63d4-824a62d2a16c2025-07-18WarningsExact identifier
application applno (ANDA): 202194
application number: ANDA202194

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
596843lansoprazole 15 MG Delayed Release Oral CapsulePSN4a701c0d-fef5-aa12-01e6-e3680a161a7d8
596843lansoprazole 15 MG Delayed Release Oral CapsuleSCD4a701c0d-fef5-aa12-01e6-e3680a161a7d8
596843lansoprazole 15 MG Delayed Release Oral CapsulePSN128c9bde-ffc8-82fa-e063-6294a90a56917
596843lansoprazole 15 MG Delayed Release Oral CapsuleSCD128c9bde-ffc8-82fa-e063-6294a90a56917
596843lansoprazole 15 MG Delayed Release Oral CapsulePSN486838cd-17ee-c2df-4e05-aa6106dd8fd85
596843lansoprazole 15 MG Delayed Release Oral CapsulePSN9f424ff5-671b-ccaf-0682-929a27feb5485
596843lansoprazole 15 MG Delayed Release Oral CapsuleSCD486838cd-17ee-c2df-4e05-aa6106dd8fd85
596843lansoprazole 15 MG Delayed Release Oral CapsuleSCD9f424ff5-671b-ccaf-0682-929a27feb5485
596843lansoprazole 15 MG Delayed Release Oral CapsulePSN277093d5-cd0f-36ad-63d4-824a62d2a16c4
596843lansoprazole 15 MG Delayed Release Oral CapsulePSNa24acc0b-7770-1087-77bd-048259a5bf724
596843lansoprazole 15 MG Delayed Release Oral CapsulePSNd78f432b-2b76-88b4-272a-169fc09318624
596843lansoprazole 15 MG Delayed Release Oral CapsuleSCD277093d5-cd0f-36ad-63d4-824a62d2a16c4
596843lansoprazole 15 MG Delayed Release Oral CapsuleSCDa24acc0b-7770-1087-77bd-048259a5bf724
596843lansoprazole 15 MG Delayed Release Oral CapsuleSCDd78f432b-2b76-88b4-272a-169fc09318624
596843lansoprazole 15 MG Delayed Release Oral CapsulePSN9e15401b-6cea-4687-8c34-4412734caaac3
596843lansoprazole 15 MG Delayed Release Oral CapsuleSCD9e15401b-6cea-4687-8c34-4412734caaac3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43598-109-27435980109272 BOTTLE in 1 CARTON (43598-109-27) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE2 bottle2022-04-120000-00-00NoNoCurrent
43598-109-33435980109333 BOTTLE in 1 CARTON (43598-109-33) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE3 bottle2022-04-120000-00-00NoNoCurrent
43598-109-52435980109521 BOTTLE in 1 CARTON (43598-109-52) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE1 bottle2022-04-120000-00-00NoNoCurrent