FDA.reportPublic FDA data

lansoprazole

Product NDC
63629-4851
Requested package NDC
63629-4851-1
11-digit product format
636294851
Labeler code
63629
Product ID
63629-4851_f3f8e70c-2f0e-40b8-8420-f8c3a905d93d
Type
HUMAN OTC DRUG
Nonproprietary name
Lansoprazole
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA202319
Marketing category
ANDA
Marketing start
2012-08-07
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

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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage63629-485163629-4851-1DDiscontinued by firm2026-10-05

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 · 13 matching rows.

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

Captured / source date, Code, Status table
Captured / source dateCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08DDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03DDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09DDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2020-06-10 20:45 UTC · source 2020-06-10IInactivated by FDA9bebd1f3094a…5416666fcb17…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A202319-001LANSOPRAZOLELANSOPRAZOLE15MGCAPSULE, 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 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A202319-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2012-05-1884e616aacf4f…
2026-08-18 06:07:402026-07A202319-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2012-05-18caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A202319-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2012-05-18011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202319-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2012-05-1831067a03dcf5…
2025-08-23 18:47 UTC2025-08A202319-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2012-05-186a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202319-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2012-05-18fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202319-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2012-05-18b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202319-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2012-05-1803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202319-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2012-05-182680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202319-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2012-05-185bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202319-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2012-05-18d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A202319-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2012-05-18d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202319-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2012-05-1879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202319-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2012-05-18301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202319-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2012-05-181e350fbaab3a…
2024-05-31 18:47 UTC2024-05A202319-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2012-05-188072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A202319-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2012-05-185c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A202319-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2012-05-185d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A202319-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2012-05-184b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A202319-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2012-05-1874a2ff9319b5…
2022-03-09 01:35 UTC2022-03A202319-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2012-05-18bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A202319-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2012-05-18782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A202319-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2012-05-1887673890dc5c…
2021-03-12 10:30 UTC2021-03A202319-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2012-05-185aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A202319-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2012-05-188869cabd3fbd…
2020-11-12 02:37 UTC2020-11A202319-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2012-05-18c0c555d07b60…
2019-12-14 00:12 UTC2019-12A202319-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2012-05-183f01610625f2…
2019-09-15 20:21 UTC2019-09A202319-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2012-05-18b00525d2431f…
2019-07-19 19:46 UTC2019-07A202319-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2012-05-18ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A202319-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2012-05-186a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A202319-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2012-05-181c564ffb4f44…
2023-12-20 04:57 UTC2023-12A202319-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2012-05-18ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A202319-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2012-05-18a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A202319-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2012-05-189b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A202319-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2012-05-18a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A202319-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2012-05-183f0d92c62455…
2023-05-13 08:27 UTC2023-05A202319-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2012-05-18053a50430f4f…
2023-01-26 05:58 UTC2023-01A202319-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2012-05-183bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A202319-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2012-05-183a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A202319-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORAL2012-05-18f41ea6bd6efb…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
63629-4851-12020-10-16Perrigo Lansoprazole Delayed-Release Capsules, 15 mg Drug Facts
63629-4851-22020-10-16Perrigo Lansoprazole Delayed-Release Capsules, 15 mg Drug Facts
63629-4851-32020-10-16Perrigo Lansoprazole Delayed-Release Capsules, 15 mg Drug Facts
63629-4851-42020-10-16Perrigo Lansoprazole Delayed-Release Capsules, 15 mg Drug Facts
63629-4851-52020-10-16Perrigo Lansoprazole Delayed-Release Capsules, 15 mg Drug Facts
63629-4851-12020-01-31Perrigo Lansoprazole Delayed-Release Capsules, 15 mg Drug Facts
63629-4851-22020-01-31Perrigo Lansoprazole Delayed-Release Capsules, 15 mg Drug Facts
63629-4851-32020-01-31Perrigo Lansoprazole Delayed-Release Capsules, 15 mg Drug Facts
63629-4851-42020-01-31Perrigo Lansoprazole Delayed-Release Capsules, 15 mg Drug Facts
63629-4851-52020-01-31Perrigo Lansoprazole Delayed-Release Capsules, 15 mg Drug Facts

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LANSOPRAZOLEACTIVE INGREDIENT0K5C5T2QPGLANSOPRAZOLE CAPSULE, DELAYED RELEASE [BRYANT RANCH PREPACK]1000
LANSOPRAZOLEACTIVE MOIETY0K5C5T2QPGLANSOPRAZOLE CAPSULE, DELAYED RELEASE [BRYANT RANCH PREPACK]1000
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHLANSOPRAZOLE CAPSULE, DELAYED RELEASE [BRYANT RANCH PREPACK]1000
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GLANSOPRAZOLE CAPSULE, DELAYED RELEASE [BRYANT RANCH PREPACK]1000
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDLANSOPRAZOLE CAPSULE, DELAYED RELEASE [BRYANT RANCH PREPACK]1000
GELATININACTIVE INGREDIENT2G86QN327LLANSOPRAZOLE CAPSULE, DELAYED RELEASE [BRYANT RANCH PREPACK]1000
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOLANSOPRAZOLE CAPSULE, DELAYED RELEASE [BRYANT RANCH PREPACK]1000
MANNITOLINACTIVE INGREDIENT3OWL53L36ALANSOPRAZOLE CAPSULE, DELAYED RELEASE [BRYANT RANCH PREPACK]1000
MEGLUMINEINACTIVE INGREDIENT6HG8UB2MUYLANSOPRAZOLE CAPSULE, DELAYED RELEASE [BRYANT RANCH PREPACK]1000
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ALANSOPRAZOLE CAPSULE, DELAYED RELEASE [BRYANT RANCH PREPACK]1000
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HLANSOPRAZOLE CAPSULE, DELAYED RELEASE [BRYANT RANCH PREPACK]1000
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JLANSOPRAZOLE CAPSULE, DELAYED RELEASE [BRYANT RANCH PREPACK]1000
TALCINACTIVE INGREDIENT7SEV7J4R1ULANSOPRAZOLE CAPSULE, DELAYED RELEASE [BRYANT RANCH PREPACK]1000
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPLANSOPRAZOLE 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 2 · 23 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LANSOPRAZOLELANSOPRAZOLEAmazon.com Services LLCa8d09f97-4c39-4aa7-a9a0-4fd2a59836bb2026-08-03WarningsExact identifier
application applno (ANDA): 202319
application number: ANDA202319
careone acid reducerLANSOPRAZOLERetail Business Services, LLCe6b42dec-3545-483f-97db-9375b3732fba2026-07-08WarningsExact identifier
application applno (ANDA): 202319
application number: ANDA202319
BERKLEY AND JENSEN LANSOPRAZOLELANSOPRAZOLEBJWCb859e8dc-e42e-448d-89fa-2fc79d9cac322026-05-21WarningsExact identifier
application applno (ANDA): 202319
application number: ANDA202319
good neighbor pharmacy lansoprazoleLANSOPRAZOLEAmerisource Bergena4ee8db4-8f8e-4326-bd32-43abd53be8e42025-12-01WarningsExact identifier
application applno (ANDA): 202319
application number: ANDA202319
Prevacid 24 HRLANSOPRAZOLEL. Perrigo Company205c9c1e-b422-4e86-a4b0-714b608adc192025-06-24WarningsExact identifier
application applno (ANDA): 202319
application number: ANDA202319
lansoprazoleLANSOPRAZOLEMeijer Distribution Incb202a695-4265-4b3b-bab8-593d479623822025-06-12WarningsExact identifier
application applno (ANDA): 202319
application number: ANDA202319
lansoprazoleLANSOPRAZOLEWalgreen Companyafcd7c51-9333-4d6f-ad18-ed95baecc7ce2025-05-12WarningsExact identifier
application applno (ANDA): 202319
application number: ANDA202319
up and up lansoprazoleLANSOPRAZOLETarget Corporation16ceaead-8dc0-49de-9438-caa146e13fba2025-04-13WarningsExact identifier
application applno (ANDA): 202319
application number: ANDA202319
lansoprazoleLANSOPRAZOLEBryant Ranch Prepackbd278054-875e-4877-991c-cbdf3975f93e2025-03-31WarningsExact identifier
application applno (ANDA): 202319
application number: ANDA202319
lansoprazoleLANSOPRAZOLEPadagis Israel Pharmaceuticals Ltd17f41872-f3d1-4b02-b6ce-0e731139495a2025-03-26WarningsExact identifier
application applno (ANDA): 202319
application number: ANDA202319
equate lansoprazoleLANSOPRAZOLEWALMART INC.3a7aadbd-0a70-444f-95e1-cbde827818922025-03-14WarningsExact identifier
application applno (ANDA): 202319
application number: ANDA202319
dg health lansoprazoleLANSOPRAZOLEDolgencorp Ince6e3bcee-636f-4361-85f8-9ba5a0f3c7412025-03-04WarningsExact identifier
application applno (ANDA): 202319
application number: ANDA202319
equaline lansoprazoleLANSOPRAZOLEUnited Natural Foods, Inc. dba UNFIbf8c337c-4a45-46e6-ae8e-46df80ca66e32025-02-13WarningsExact identifier
application applno (ANDA): 202319
application number: ANDA202319
lansoprazoleLANSOPRAZOLEPublix Super Markets Inc86a99ee3-0e98-46e8-8473-f8c812044a2f2025-02-13WarningsExact identifier
application applno (ANDA): 202319
application number: ANDA202319
topcare lansoprazoleLANSOPRAZOLETopco Associates LLC73aec019-5337-48a4-b95c-993fff9cfc2a2025-02-13WarningsExact identifier
application applno (ANDA): 202319
application number: ANDA202319
Kirkland Signature LansoprazoleLANSOPRAZOLECostco Wholesale Company326aabe6-c4ac-4bca-949f-38015dcbaf4e2025-02-12WarningsExact identifier
application applno (ANDA): 202319
application number: ANDA202319
basic care lansoprazoleLANSOPRAZOLEAmazon.com Services LLC6b57eb00-74fd-435f-bd08-086c9f8ac62c2025-02-05WarningsExact identifier
application applno (ANDA): 202319
application number: ANDA202319
Members Mark LansoprazoleLANSOPRAZOLESam's West Incfee84ce3-a884-4944-a32b-72e69a1229d42024-07-15WarningsExact identifier
application applno (ANDA): 202319
application number: ANDA202319
Good Sense LansoprazoleLANSOPRAZOLEL. Perrigo Company91d69826-df5c-47a2-b852-3083629d18932024-06-17WarningsExact identifier
application applno (ANDA): 202319
application number: ANDA202319
foster and thrive acid reducerLANSOPRAZOLEStrategic Sourcing Services LLCd02e2f93-3358-4682-b491-0a83889af8a12023-09-14WarningsExact identifier
application applno (ANDA): 202319
application number: ANDA202319

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63629-4851-16362948510130 CAPSULE, DELAYED RELEASE in 1 BOTTLE (63629-4851-1) 2012-12-280000-00-00NoNoCurrent