LANSOPRAZOLE

Product NDC
52959-352
11-digit product format
529590352
Labeler code
52959
Product ID
52959-352_677d2e71-fbb2-1cc5-e053-2a91aa0a171b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
LANSOPRAZOLE
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
H.J. Harkins Co., Inc
Application
ANDA091269
Marketing category
ANDA
Marketing start
2018-01-09
Marketing end
0000-00-00
Substance
LANSOPRAZOLE
Active strength
30 mg/1
Pharmacologic classes
Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Inhibition Gastric Acid Secretion [PE]
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct52959-352IInactivated by FDA2026-08-03
excluded packagepackage52959-35252959-352-07IInactivated by FDA2026-08-03
excluded packagepackage52959-35252959-352-14IInactivated by FDA2026-08-03

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 2 · 63 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 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage52959-352-07d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage52959-352-14d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage52959-352-07f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage52959-352-14f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage52959-352-072ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage52959-352-142ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage52959-352-07a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage52959-352-14a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage52959-352-07cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage52959-352-14cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage52959-352-07cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage52959-352-14cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage52959-352-07302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage52959-352-14302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage52959-352-07ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage52959-352-14ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage52959-352-070efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage52959-352-140efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage52959-352-07ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage52959-352-14ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage52959-352-07367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage52959-352-14367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage52959-352-07557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage52959-352-14557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage52959-352-078af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage52959-352-148af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage52959-352-07834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage52959-352-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage52959-352-071332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage52959-352-141332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage52959-352-07fb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage52959-352-14fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage52959-352-0786f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage52959-352-1486f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage52959-352-07bd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage52959-352-14bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage52959-352-078dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage52959-352-148dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage52959-352-07e2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage52959-352-14e2bbac7714bc…27bdfed8d636…

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…

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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52959-352-072020-01-31C16284748780-19d75b9d1-0174-f424-e053-dadaa90a57ce677d2e71-fbb1-1cc5-e053-2a91aa0a171b
52959-352-142020-01-31C16284748780-19d75b9d1-0174-f424-e053-dadaa90a57ce677d2e71-fbb1-1cc5-e053-2a91aa0a171b

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52959-352-07LANSOPRAZOLE7 in 1 VIALCAPSULE, DELAYED RELEASE71
52959-352-14LANSOPRAZOLE14 in 1 VIALCAPSULE, DELAYED RELEASE141

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52959-352LANSOPRAZOLE CAPSULE, DELAYED RELEASE [H.J. HARKINS CO., INC]1Legacy NDC, 2 package rows20180328_677d2e71-fbb1-1cc5-e053-2a91aa0a171b.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
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
311277lansoprazole 30 MG Delayed Release Oral CapsulePSN677d2e71-fbb1-1cc5-e053-2a91aa0a171b1
311277lansoprazole 30 MG Delayed Release Oral CapsuleSCD677d2e71-fbb1-1cc5-e053-2a91aa0a171b1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
52959-352-07529590352077 in 1 VIALHistorical
52959-352-145295903521414 in 1 VIALHistorical