Lansoprazole

Product NDC
55648-670
11-digit product format
556480670
Labeler code
55648
Product ID
55648-670_ad574d8c-de35-45d3-8cdb-4f56e18ec0d9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lansoprazole
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Wockhardt Limited
Application
ANDA202176
Marketing category
ANDA
Marketing start
2012-08-10
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
E
Listing certified through
2017-12-31
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 · 8 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct55648-670IInactivated by FDA2026-08-03
excluded packagepackage55648-67055648-670-01IInactivated by FDA2026-08-03
excluded packagepackage55648-67055648-670-02IInactivated by FDA2026-08-03
excluded packagepackage55648-67055648-670-03IInactivated by FDA2026-08-03
excluded packagepackage55648-67055648-670-04IInactivated by FDA2026-08-03
excluded packagepackage55648-67055648-670-05IInactivated by FDA2026-08-03
excluded packagepackage55648-67055648-670-06IInactivated by FDA2026-08-03
excluded packagepackage55648-67055648-670-07IInactivated 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 3 · 176 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 packagepackage55648-670-01d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage55648-670-04d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage55648-670-07d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage55648-670-05d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage55648-670-03d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage55648-670-02d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage55648-670-06d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage55648-670-01f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage55648-670-04f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage55648-670-07f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage55648-670-05f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage55648-670-03f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage55648-670-02f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage55648-670-06f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage55648-670-012ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage55648-670-042ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage55648-670-072ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage55648-670-052ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage55648-670-032ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage55648-670-022ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage55648-670-062ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage55648-670-01a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage55648-670-04a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage55648-670-07a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage55648-670-05a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage55648-670-03a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage55648-670-02a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage55648-670-06a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage55648-670-01cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage55648-670-04cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage55648-670-07cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage55648-670-05cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage55648-670-03cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage55648-670-02cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage55648-670-06cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage55648-670-01cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage55648-670-04cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage55648-670-07cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage55648-670-05cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage55648-670-03cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage55648-670-02cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage55648-670-06cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage55648-670-01302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage55648-670-04302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage55648-670-07302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage55648-670-05302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage55648-670-03302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage55648-670-02302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage55648-670-06302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage55648-670-01ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage55648-670-04ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage55648-670-07ed331223b511…672a5bd82f5f…

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
A202176-001LANSOPRAZOLELANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORALAB2012-09-14
A202176-002LANSOPRAZOLELANSOPRAZOLE30MGCAPSULE, DELAYED REL PELLETS / ORALAB2012-09-14

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A202176-001AB
A202176-002AB

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 UTC2026-02A202176-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORALAB2012-09-14011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202176-002LANSOPRAZOLE30MGCAPSULE, DELAYED REL PELLETS / ORALAB2012-09-14011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202176-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORALAB2012-09-1431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202176-002LANSOPRAZOLE30MGCAPSULE, DELAYED REL PELLETS / ORALAB2012-09-1431067a03dcf5…
2025-08-23 18:47 UTC2025-08A202176-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORALAB2012-09-146a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202176-002LANSOPRAZOLE30MGCAPSULE, DELAYED REL PELLETS / ORALAB2012-09-146a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202176-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORALAB2012-09-14fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202176-002LANSOPRAZOLE30MGCAPSULE, DELAYED REL PELLETS / ORALAB2012-09-14fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202176-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORALAB2012-09-14b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202176-002LANSOPRAZOLE30MGCAPSULE, DELAYED REL PELLETS / ORALAB2012-09-14b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202176-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORALAB2012-09-1403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202176-002LANSOPRAZOLE30MGCAPSULE, DELAYED REL PELLETS / ORALAB2012-09-1403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202176-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORALAB2012-09-142680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202176-002LANSOPRAZOLE30MGCAPSULE, DELAYED REL PELLETS / ORALAB2012-09-142680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202176-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORALAB2012-09-145bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202176-002LANSOPRAZOLE30MGCAPSULE, DELAYED REL PELLETS / ORALAB2012-09-145bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202176-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORALAB2012-09-14d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202176-002LANSOPRAZOLE30MGCAPSULE, DELAYED REL PELLETS / ORALAB2012-09-14d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A202176-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORALAB2012-09-14d06236e962d9…
2024-10-29 15:01 UTC2024-10A202176-002LANSOPRAZOLE30MGCAPSULE, DELAYED REL PELLETS / ORALAB2012-09-14d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202176-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORALAB2012-09-1479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202176-002LANSOPRAZOLE30MGCAPSULE, DELAYED REL PELLETS / ORALAB2012-09-1479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202176-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORALAB2012-09-14301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202176-002LANSOPRAZOLE30MGCAPSULE, DELAYED REL PELLETS / ORALAB2012-09-14301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202176-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORALAB2012-09-141e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202176-002LANSOPRAZOLE30MGCAPSULE, DELAYED REL PELLETS / ORALAB2012-09-141e350fbaab3a…
2024-05-31 18:47 UTC2024-05A202176-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORALAB2012-09-148072bd15b7f6…
2024-05-31 18:47 UTC2024-05A202176-002LANSOPRAZOLE30MGCAPSULE, DELAYED REL PELLETS / ORALAB2012-09-148072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A202176-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORALAB2012-09-145c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A202176-002LANSOPRAZOLE30MGCAPSULE, DELAYED REL PELLETS / ORALAB2012-09-145c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A202176-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORALAB2012-09-145d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A202176-002LANSOPRAZOLE30MGCAPSULE, DELAYED REL PELLETS / ORALAB2012-09-145d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A202176-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORALAB2012-09-144b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A202176-002LANSOPRAZOLE30MGCAPSULE, DELAYED REL PELLETS / ORALAB2012-09-144b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A202176-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORALAB2012-09-1474a2ff9319b5…
2019-12-13 00:20 UTC2019-12A202176-002LANSOPRAZOLE30MGCAPSULE, DELAYED REL PELLETS / ORALAB2012-09-1474a2ff9319b5…
2022-03-09 01:35 UTC2022-03A202176-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORALAB2012-09-14bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A202176-002LANSOPRAZOLE30MGCAPSULE, DELAYED REL PELLETS / ORALAB2012-09-14bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A202176-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORALAB2012-09-14782e0a99824c…
2021-12-28 21:50 UTC2021-12A202176-002LANSOPRAZOLE30MGCAPSULE, DELAYED REL PELLETS / ORALAB2012-09-14782e0a99824c…

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 UTC2026-02A202176-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202176-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202176-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202176-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A202176-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202176-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202176-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202176-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202176-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202176-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202176-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202176-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202176-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202176-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202176-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202176-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202176-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202176-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A202176-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A202176-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202176-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202176-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202176-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202176-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202176-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202176-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A202176-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A202176-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A202176-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A202176-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A202176-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A202176-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A202176-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A202176-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A202176-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A202176-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A202176-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A202176-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A202176-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A202176-002AB1782e0a99824c…

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, Related label table
NDCRelated label
55648-670-01These highlights do not include all the information needed to use lansoprazole safely and effectively. See full prescribing information for: Lansoprazole Delayed-Release Capsules, USP For oral administration Initial U.S. Approval: 1995
55648-670-02These highlights do not include all the information needed to use lansoprazole safely and effectively. See full prescribing information for: Lansoprazole Delayed-Release Capsules, USP For oral administration Initial U.S. Approval: 1995
55648-670-03These highlights do not include all the information needed to use lansoprazole safely and effectively. See full prescribing information for: Lansoprazole Delayed-Release Capsules, USP For oral administration Initial U.S. Approval: 1995
55648-670-04These highlights do not include all the information needed to use lansoprazole safely and effectively. See full prescribing information for: Lansoprazole Delayed-Release Capsules, USP For oral administration Initial U.S. Approval: 1995
55648-670-05These highlights do not include all the information needed to use lansoprazole safely and effectively. See full prescribing information for: Lansoprazole Delayed-Release Capsules, USP For oral administration Initial U.S. Approval: 1995
55648-670-06These highlights do not include all the information needed to use lansoprazole safely and effectively. See full prescribing information for: Lansoprazole Delayed-Release Capsules, USP For oral administration Initial U.S. Approval: 1995
55648-670-07These highlights do not include all the information needed to use lansoprazole safely and effectively. See full prescribing information for: Lansoprazole Delayed-Release Capsules, USP For oral administration Initial U.S. Approval: 1995

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55648-670-01Lansoprazole30 in 1 BOTTLECAPSULE, DELAYED RELEASE301
55648-670-02Lansoprazole60 in 1 BOTTLECAPSULE, DELAYED RELEASE601
55648-670-03Lansoprazole100 in 1 BOTTLECAPSULE, DELAYED RELEASE1001
55648-670-04Lansoprazole500 in 1 BOTTLECAPSULE, DELAYED RELEASE5001
55648-670-05Lansoprazole1000 in 1 BOTTLECAPSULE, DELAYED RELEASE10001
55648-670-06Lansoprazole10 in 1 CARTONCAPSULE, DELAYED RELEASE101
55648-670-06Lansoprazole10 in 1 BLISTER PACKCAPSULE, DELAYED RELEASE101
55648-670-07Lansoprazole90 in 1 BOTTLECAPSULE, DELAYED RELEASE901

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LANSOPRAZOLEACTIVE INGREDIENT0K5C5T2QPGLANSOPRAZOLE CAPSULE, DELAYED RELEASE [WOCKHARDT LIMITED]1
LANSOPRAZOLEACTIVE MOIETY0K5C5T2QPGLANSOPRAZOLE CAPSULE, DELAYED RELEASE [WOCKHARDT LIMITED]1
D&C RED NO. 33INACTIVE INGREDIENT9DBA0SBB0LLANSOPRAZOLE CAPSULE, DELAYED RELEASE [WOCKHARDT LIMITED]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GLANSOPRAZOLE CAPSULE, DELAYED RELEASE [WOCKHARDT LIMITED]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDLANSOPRAZOLE CAPSULE, DELAYED RELEASE [WOCKHARDT LIMITED]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357LANSOPRAZOLE CAPSULE, DELAYED RELEASE [WOCKHARDT LIMITED]1
GELATININACTIVE INGREDIENT2G86QN327LLANSOPRAZOLE CAPSULE, DELAYED RELEASE [WOCKHARDT LIMITED]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOLANSOPRAZOLE CAPSULE, DELAYED RELEASE [WOCKHARDT LIMITED]1
MAGNESIUM CARBONATEINACTIVE INGREDIENT0E53J927NALANSOPRAZOLE CAPSULE, DELAYED RELEASE [WOCKHARDT LIMITED]1
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)INACTIVE INGREDIENT74G4R6TH13LANSOPRAZOLE CAPSULE, DELAYED RELEASE [WOCKHARDT LIMITED]1
POLYETHYLENE GLYCOL 6000INACTIVE INGREDIENT30IQX730WELANSOPRAZOLE CAPSULE, DELAYED RELEASE [WOCKHARDT LIMITED]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HLANSOPRAZOLE CAPSULE, DELAYED RELEASE [WOCKHARDT LIMITED]1
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4TLANSOPRAZOLE CAPSULE, DELAYED RELEASE [WOCKHARDT LIMITED]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3LANSOPRAZOLE CAPSULE, DELAYED RELEASE [WOCKHARDT LIMITED]1
SHELLACINACTIVE INGREDIENT46N107B71OLANSOPRAZOLE CAPSULE, DELAYED RELEASE [WOCKHARDT LIMITED]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4LANSOPRAZOLE CAPSULE, DELAYED RELEASE [WOCKHARDT LIMITED]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJLANSOPRAZOLE CAPSULE, DELAYED RELEASE [WOCKHARDT LIMITED]1
SUCROSEINACTIVE INGREDIENTC151H8M554LANSOPRAZOLE CAPSULE, DELAYED RELEASE [WOCKHARDT LIMITED]1
TALCINACTIVE INGREDIENT7SEV7J4R1ULANSOPRAZOLE CAPSULE, DELAYED RELEASE [WOCKHARDT LIMITED]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPLANSOPRAZOLE CAPSULE, DELAYED RELEASE [WOCKHARDT LIMITED]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55648-670LANSOPRAZOLE CAPSULE, DELAYED RELEASE [WOCKHARDT LIMITED]1Legacy NDC, 8 package rows20120915_1e8f34ce-a484-483f-aba9-a0820ec6d1a1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
596843lansoprazole 15 MG Delayed Release Oral CapsulePSN1e8f34ce-a484-483f-aba9-a0820ec6d1a11
311277lansoprazole 30 MG Delayed Release Oral CapsulePSN1e8f34ce-a484-483f-aba9-a0820ec6d1a11
596843lansoprazole 15 MG Delayed Release Oral CapsuleSCD1e8f34ce-a484-483f-aba9-a0820ec6d1a11
311277lansoprazole 30 MG Delayed Release Oral CapsuleSCD1e8f34ce-a484-483f-aba9-a0820ec6d1a11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
55648-670-015564806700130 in 1 BOTTLEHistorical
55648-670-025564806700260 in 1 BOTTLEHistorical
55648-670-0355648067003100 in 1 BOTTLEHistorical
55648-670-0455648067004500 in 1 BOTTLEHistorical
55648-670-05556480670051000 in 1 BOTTLEHistorical
55648-670-065564806700610 in 1 CARTONHistorical
55648-670-075564806700790 in 1 BOTTLEHistorical