Prevacid

Product NDC
63629-3352
11-digit product format
636293352
Labeler code
63629
Product ID
63629-3352_716daf76-5d5c-4a8b-9cfe-e465555851e8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
lansoprazole
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
NDA020406
Marketing category
NDA
Marketing start
1995-05-10
Marketing end
0000-00-00
Substance
LANSOPRAZOLE
Active strength
15 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 · 4 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct63629-3352DDiscontinued by firm2026-08-17
excluded packagepackage63629-335263629-3352-1DDiscontinued by firm2026-08-17
excluded packagepackage63629-335263629-3352-2DDiscontinued by firm2026-08-17
excluded packagepackage63629-335263629-3352-3DDiscontinued by firm2026-08-17

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 · 60 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 productproductDDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage63629-3352-3DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage63629-3352-1DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage63629-3352-2DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductDDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63629-3352-3DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63629-3352-1DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63629-3352-2DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductDDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage63629-3352-3DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage63629-3352-1DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage63629-3352-2DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductDDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage63629-3352-3DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage63629-3352-1DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage63629-3352-2DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductDDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage63629-3352-3DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage63629-3352-1DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage63629-3352-2DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductDDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage63629-3352-3DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage63629-3352-1DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage63629-3352-2DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductDDiscontinued by firm302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage63629-3352-3DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage63629-3352-1DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage63629-3352-2DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductDDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage63629-3352-3DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage63629-3352-1DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage63629-3352-2DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductDDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage63629-3352-3DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage63629-3352-1DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage63629-3352-2DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductDDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage63629-3352-3DDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage63629-3352-1DDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage63629-3352-2DDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductDDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage63629-3352-3DDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage63629-3352-1DDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage63629-3352-2DDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductDDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage63629-3352-3DDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage63629-3352-1DDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage63629-3352-2DDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproductIInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage63629-3352-1IInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage63629-3352-2IInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage63629-3352-3IInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproductIInactivated by FDA9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage63629-3352-1IInactivated by FDA9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage63629-3352-2IInactivated by FDA9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage63629-3352-3IInactivated by FDA9bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproductEExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage63629-3352-3EExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage63629-3352-1EExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage63629-3352-2EExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
N020406-001PREVACIDLANSOPRAZOLE15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE, DELAYED REL PELLETS / ORALRLD1995-05-10
N020406-002PREVACIDLANSOPRAZOLE30MGCAPSULE, DELAYED REL PELLETS / ORALABRLD, RS1995-05-10

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
N020406-002AB

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 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07N020406-001PREVACID15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE, DELAYED REL PELLETS / ORALRLD1995-05-10caaa826d4ba7…
2026-08-18 06:07:402026-07N020406-002PREVACID30MGCAPSULE, DELAYED REL PELLETS / ORALABRLD, RS1995-05-10caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N020406-001PREVACID15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE, DELAYED REL PELLETS / ORALRLD1995-05-10011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020406-002PREVACID30MGCAPSULE, DELAYED REL PELLETS / ORALABRLD, RS1995-05-10011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020406-001PREVACID15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE, DELAYED REL PELLETS / ORALRLD1995-05-1031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020406-002PREVACID30MGCAPSULE, DELAYED REL PELLETS / ORALABRLD, RS1995-05-1031067a03dcf5…
2025-08-23 18:47 UTC2025-08N020406-001PREVACID15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE, DELAYED REL PELLETS / ORALRLD1995-05-106a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020406-002PREVACID30MGCAPSULE, DELAYED REL PELLETS / ORALABRLD, RS1995-05-106a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020406-001PREVACID15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE, DELAYED REL PELLETS / ORALRLD1995-05-10fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020406-002PREVACID30MGCAPSULE, DELAYED REL PELLETS / ORALABRLD, RS1995-05-10fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020406-001PREVACID15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE, DELAYED REL PELLETS / ORALRLD1995-05-10b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020406-002PREVACID30MGCAPSULE, DELAYED REL PELLETS / ORALABRLD, RS1995-05-10b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020406-001PREVACID15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE, DELAYED REL PELLETS / ORALRLD1995-05-1003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020406-002PREVACID30MGCAPSULE, DELAYED REL PELLETS / ORALABRLD, RS1995-05-1003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020406-001PREVACID15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE, DELAYED REL PELLETS / ORALRLD1995-05-102680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020406-002PREVACID30MGCAPSULE, DELAYED REL PELLETS / ORALABRLD, RS1995-05-102680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020406-001PREVACID15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE, DELAYED REL PELLETS / ORALRLD1995-05-105bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020406-002PREVACID30MGCAPSULE, DELAYED REL PELLETS / ORALABRLD, RS1995-05-105bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020406-001PREVACID15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE, DELAYED REL PELLETS / ORALRLD1995-05-10d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020406-002PREVACID30MGCAPSULE, DELAYED REL PELLETS / ORALABRLD, RS1995-05-10d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N020406-001PREVACID15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE, DELAYED REL PELLETS / ORALRLD1995-05-10d06236e962d9…
2024-10-29 15:01 UTC2024-10N020406-002PREVACID30MGCAPSULE, DELAYED REL PELLETS / ORALABRLD, RS1995-05-10d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020406-001PREVACID15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE, DELAYED REL PELLETS / ORALRLD1995-05-1079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020406-002PREVACID30MGCAPSULE, DELAYED REL PELLETS / ORALABRLD, RS1995-05-1079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020406-001PREVACID15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE, DELAYED REL PELLETS / ORALRLD1995-05-10301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020406-002PREVACID30MGCAPSULE, DELAYED REL PELLETS / ORALABRLD, RS1995-05-10301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020406-001PREVACID15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE, DELAYED REL PELLETS / ORALRLD1995-05-101e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020406-002PREVACID30MGCAPSULE, DELAYED REL PELLETS / ORALABRLD, RS1995-05-101e350fbaab3a…
2024-05-31 18:47 UTC2024-05N020406-001PREVACID15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE, DELAYED REL PELLETS / ORALRLD1995-05-108072bd15b7f6…
2024-05-31 18:47 UTC2024-05N020406-002PREVACID30MGCAPSULE, DELAYED REL PELLETS / ORALABRLD, RS1995-05-108072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N020406-001PREVACID15MGCAPSULE, DELAYED REL PELLETS / ORALRLD1995-05-105c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N020406-002PREVACID30MGCAPSULE, DELAYED REL PELLETS / ORALABRLD, RS1995-05-105c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N020406-001PREVACID15MGCAPSULE, DELAYED REL PELLETS / ORALRLD1995-05-105d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N020406-002PREVACID30MGCAPSULE, DELAYED REL PELLETS / ORALABRLD, RS1995-05-105d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N020406-001PREVACID15MGCAPSULE, DELAYED REL PELLETS / ORALRLD1995-05-104b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N020406-002PREVACID30MGCAPSULE, DELAYED REL PELLETS / ORALABRLD, RS1995-05-104b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N020406-001PREVACID15MGCAPSULE, DELAYED REL PELLETS / ORALABRLD1995-05-1074a2ff9319b5…
2019-12-13 00:20 UTC2019-12N020406-002PREVACID30MGCAPSULE, DELAYED REL PELLETS / ORALABRLD, RS1995-05-1074a2ff9319b5…
2022-03-09 01:35 UTC2022-03N020406-001PREVACID15MGCAPSULE, DELAYED REL PELLETS / ORALRLD1995-05-10bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N020406-002PREVACID30MGCAPSULE, DELAYED REL PELLETS / ORALABRLD, RS1995-05-10bb7c543d1eb4…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 50 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07N020406-002AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N020406-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020406-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08N020406-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020406-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020406-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020406-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020406-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020406-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020406-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N020406-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020406-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020406-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020406-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N020406-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N020406-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N020406-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N020406-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N020406-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12N020406-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N020406-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N020406-002AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N020406-001AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N020406-002AB187673890dc5c…
2021-03-12 10:30 UTC2021-03N020406-001AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N020406-002AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N020406-001AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12N020406-002AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11N020406-001AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11N020406-002AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12N020406-001AB13f01610625f2…
2019-12-14 00:12 UTC2019-12N020406-002AB13f01610625f2…
2019-09-15 20:21 UTC2019-09N020406-001AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09N020406-002AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07N020406-001AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07N020406-002AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N020406-002AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N020406-002AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12N020406-002AB1ea1830bbd6c7…
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FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
63629-3352-12021-08-17These highlights do not include all the information needed to use PREVACID safely and effectively. See full prescribing information for Prevacid: PREVACID (lansoprazole) delayed-release capsules, for oral use PREVACID SoluTab (lansoprazole) delayed-release orally disintegrating tablets, for oral use Initial U.S. Approval: 1995
63629-3352-22021-08-17These highlights do not include all the information needed to use PREVACID safely and effectively. See full prescribing information for Prevacid: PREVACID (lansoprazole) delayed-release capsules, for oral use PREVACID SoluTab (lansoprazole) delayed-release orally disintegrating tablets, for oral use Initial U.S. Approval: 1995
63629-3352-32021-08-17These highlights do not include all the information needed to use PREVACID safely and effectively. See full prescribing information for Prevacid: PREVACID (lansoprazole) delayed-release capsules, for oral use PREVACID SoluTab (lansoprazole) delayed-release orally disintegrating tablets, for oral use Initial U.S. Approval: 1995
63629-3352-12020-01-31These highlights do not include all the information needed to use PREVACID safely and effectively. See full prescribing information for Prevacid: PREVACID (lansoprazole) delayed-release capsules, for oral use PREVACID SoluTab (lansoprazole) delayed-release orally disintegrating tablets, for oral use Initial U.S. Approval: 1995
63629-3352-22020-01-31These highlights do not include all the information needed to use PREVACID safely and effectively. See full prescribing information for Prevacid: PREVACID (lansoprazole) delayed-release capsules, for oral use PREVACID SoluTab (lansoprazole) delayed-release orally disintegrating tablets, for oral use Initial U.S. Approval: 1995
63629-3352-32020-01-31These highlights do not include all the information needed to use PREVACID safely and effectively. See full prescribing information for Prevacid: PREVACID (lansoprazole) delayed-release capsules, for oral use PREVACID SoluTab (lansoprazole) delayed-release orally disintegrating tablets, for oral use Initial U.S. Approval: 1995

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-3352-1EA - Each63629-3352d8528450-7d66-490a-b5e5-361f81dc4ea312015-05-05
63629-3352-2EA - Each63629-3352b1418736-0b48-47fd-a856-cff5f985d50512015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LANSOPRAZOLEACTIVE INGREDIENT0K5C5T2QPGPREVACID (LANSOPRAZOLE) CAPSULE, DELAYED RELEASE [BRYANT RANCH PREPACK]1000
LANSOPRAZOLEACTIVE MOIETY0K5C5T2QPGPREVACID (LANSOPRAZOLE) CAPSULE, DELAYED RELEASE [BRYANT RANCH PREPACK]1000
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHPREVACID (LANSOPRAZOLE) CAPSULE, DELAYED RELEASE [BRYANT RANCH PREPACK]1000
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDPREVACID (LANSOPRAZOLE) CAPSULE, DELAYED RELEASE [BRYANT RANCH PREPACK]1000
FD&C GREEN NO. 3INACTIVE INGREDIENT3P3ONR6O1SPREVACID (LANSOPRAZOLE) CAPSULE, DELAYED RELEASE [BRYANT RANCH PREPACK]1000
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAPREVACID (LANSOPRAZOLE) CAPSULE, DELAYED RELEASE [BRYANT RANCH PREPACK]1000
HYDROXYPROPYL CELLULOSE (TYPE E)INACTIVE INGREDIENT66O7AQV0RTPREVACID (LANSOPRAZOLE) CAPSULE, DELAYED RELEASE [BRYANT RANCH PREPACK]1000
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTEDINACTIVE INGREDIENT2165RE0K14PREVACID (LANSOPRAZOLE) CAPSULE, DELAYED RELEASE [BRYANT RANCH PREPACK]1000
MAGNESIUM CARBONATEINACTIVE INGREDIENT0E53J927NAPREVACID (LANSOPRAZOLE) CAPSULE, DELAYED RELEASE [BRYANT RANCH PREPACK]1000
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AINACTIVE INGREDIENTNX76LV5T8JPREVACID (LANSOPRAZOLE) CAPSULE, DELAYED RELEASE [BRYANT RANCH PREPACK]1000
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1APREVACID (LANSOPRAZOLE) CAPSULE, DELAYED RELEASE [BRYANT RANCH PREPACK]1000
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HPREVACID (LANSOPRAZOLE) CAPSULE, DELAYED RELEASE [BRYANT RANCH PREPACK]1000
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4PREVACID (LANSOPRAZOLE) CAPSULE, DELAYED RELEASE [BRYANT RANCH PREPACK]1000
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJPREVACID (LANSOPRAZOLE) CAPSULE, DELAYED RELEASE [BRYANT RANCH PREPACK]1000
SUCROSEINACTIVE INGREDIENTC151H8M554PREVACID (LANSOPRAZOLE) CAPSULE, DELAYED RELEASE [BRYANT RANCH PREPACK]1000
TALCINACTIVE INGREDIENT7SEV7J4R1UPREVACID (LANSOPRAZOLE) CAPSULE, DELAYED RELEASE [BRYANT RANCH PREPACK]1000
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPPREVACID (LANSOPRAZOLE) CAPSULE, DELAYED RELEASE [BRYANT RANCH PREPACK]1000

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PrevacidLANSOPRAZOLETakeda Pharmaceuticals America, Inc.71ba78cb-7e46-43eb-9425-fa130f537f842025-07-08Warnings, Adverse reactionsExact identifier
application applno (NDA): 020406
application number: NDA020406