LANSOPRAZOLE

Product NDC
51991-772
Requested package NDC
51991-772-33
11-digit product format
519910772
Labeler code
51991
Product ID
51991-772_a2884a15-5249-4f2e-ae9f-bbf2f942421e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
LANSOPRAZOLE
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Breckenridge Pharmaceutical, Inc.
Application
ANDA201921
Marketing category
ANDA
Marketing start
2012-12-18
Marketing end
2021-05-31
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
0000-00-00
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 packagepackage51991-77251991-772-33DDiscontinued 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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

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
A201921-001LANSOPRAZOLELANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORALAB2012-12-18
A201921-002LANSOPRAZOLELANSOPRAZOLE30MGCAPSULE, DELAYED REL PELLETS / ORALAB2012-12-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A201921-001AB
A201921-002AB

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 06:07:402026-07A201921-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORALAB2012-12-18caaa826d4ba7…
2026-08-18 06:07:402026-07A201921-002LANSOPRAZOLE30MGCAPSULE, DELAYED REL PELLETS / ORALAB2012-12-18caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A201921-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORALAB2012-12-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02A201921-002LANSOPRAZOLE30MGCAPSULE, DELAYED REL PELLETS / ORALAB2012-12-18011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201921-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORALAB2012-12-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201921-002LANSOPRAZOLE30MGCAPSULE, DELAYED REL PELLETS / ORALAB2012-12-1831067a03dcf5…
2025-08-23 18:47 UTC2025-08A201921-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORALAB2012-12-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08A201921-002LANSOPRAZOLE30MGCAPSULE, DELAYED REL PELLETS / ORALAB2012-12-186a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201921-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORALAB2012-12-18fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201921-002LANSOPRAZOLE30MGCAPSULE, DELAYED REL PELLETS / ORALAB2012-12-18fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201921-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORALAB2012-12-18b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201921-002LANSOPRAZOLE30MGCAPSULE, DELAYED REL PELLETS / ORALAB2012-12-18b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201921-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORALAB2012-12-1803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201921-002LANSOPRAZOLE30MGCAPSULE, DELAYED REL PELLETS / ORALAB2012-12-1803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201921-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORALAB2012-12-182680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201921-002LANSOPRAZOLE30MGCAPSULE, DELAYED REL PELLETS / ORALAB2012-12-182680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A201921-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORALAB2012-12-185bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A201921-002LANSOPRAZOLE30MGCAPSULE, DELAYED REL PELLETS / ORALAB2012-12-185bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A201921-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORALAB2012-12-18d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A201921-002LANSOPRAZOLE30MGCAPSULE, DELAYED REL PELLETS / ORALAB2012-12-18d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A201921-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORALAB2012-12-18d06236e962d9…
2024-10-29 15:01 UTC2024-10A201921-002LANSOPRAZOLE30MGCAPSULE, DELAYED REL PELLETS / ORALAB2012-12-18d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A201921-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORALAB2012-12-1879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A201921-002LANSOPRAZOLE30MGCAPSULE, DELAYED REL PELLETS / ORALAB2012-12-1879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A201921-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORALAB2012-12-18301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A201921-002LANSOPRAZOLE30MGCAPSULE, DELAYED REL PELLETS / ORALAB2012-12-18301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A201921-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORALAB2012-12-181e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A201921-002LANSOPRAZOLE30MGCAPSULE, DELAYED REL PELLETS / ORALAB2012-12-181e350fbaab3a…
2024-05-31 18:47 UTC2024-05A201921-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORALAB2012-12-188072bd15b7f6…
2024-05-31 18:47 UTC2024-05A201921-002LANSOPRAZOLE30MGCAPSULE, DELAYED REL PELLETS / ORALAB2012-12-188072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A201921-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORALAB2012-12-185c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A201921-002LANSOPRAZOLE30MGCAPSULE, DELAYED REL PELLETS / ORALAB2012-12-185c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A201921-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORALAB2012-12-185d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A201921-002LANSOPRAZOLE30MGCAPSULE, DELAYED REL PELLETS / ORALAB2012-12-185d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A201921-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORALAB2012-12-184b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A201921-002LANSOPRAZOLE30MGCAPSULE, DELAYED REL PELLETS / ORALAB2012-12-184b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A201921-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORALAB2012-12-1874a2ff9319b5…
2019-12-13 00:20 UTC2019-12A201921-002LANSOPRAZOLE30MGCAPSULE, DELAYED REL PELLETS / ORALAB2012-12-1874a2ff9319b5…
2022-03-09 01:35 UTC2022-03A201921-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORALAB2012-12-18bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A201921-002LANSOPRAZOLE30MGCAPSULE, DELAYED REL PELLETS / ORALAB2012-12-18bb7c543d1eb4…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A201921-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A201921-002AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A201921-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A201921-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201921-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201921-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A201921-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A201921-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201921-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201921-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201921-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201921-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201921-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201921-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201921-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201921-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A201921-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A201921-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A201921-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A201921-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A201921-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A201921-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A201921-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A201921-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A201921-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A201921-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A201921-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A201921-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A201921-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A201921-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A201921-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A201921-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A201921-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A201921-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A201921-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A201921-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A201921-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A201921-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A201921-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A201921-002AB1bb7c543d1eb4…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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
51991-772-05EA - Each51991-7722587a30d-4f5a-424a-8e24-c8cb107ede9d12013-02-13
51991-772-33EA - Each51991-7723a03d9bf-d97a-4a65-8cfa-0ff5f26a781012013-02-13
51991-772-90EA - Each51991-7729a937bee-5b89-43c5-a91b-cbdc0d3dc15e12013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LANSOPRAZOLEACTIVE INGREDIENT0K5C5T2QPGLANSOPRAZOLE CAPSULE, DELAYED RELEASE [BRECKENRIDGE PHARMACEUTICAL, INC.]4
LANSOPRAZOLEACTIVE MOIETY0K5C5T2QPGLANSOPRAZOLE CAPSULE, DELAYED RELEASE [BRECKENRIDGE PHARMACEUTICAL, INC.]4
ACETONEINACTIVE INGREDIENT1364PS73AFLANSOPRAZOLE CAPSULE, DELAYED RELEASE [BRECKENRIDGE PHARMACEUTICAL, INC.]4
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOLANSOPRAZOLE CAPSULE, DELAYED RELEASE [BRECKENRIDGE PHARMACEUTICAL, INC.]4
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302LANSOPRAZOLE CAPSULE, DELAYED RELEASE [BRECKENRIDGE PHARMACEUTICAL, INC.]4
MAGNESIUM CARBONATEINACTIVE INGREDIENT0E53J927NALANSOPRAZOLE CAPSULE, DELAYED RELEASE [BRECKENRIDGE PHARMACEUTICAL, INC.]4
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AINACTIVE INGREDIENTNX76LV5T8JLANSOPRAZOLE CAPSULE, DELAYED RELEASE [BRECKENRIDGE PHARMACEUTICAL, INC.]4
POLYETHYLENE GLYCOL 4000INACTIVE INGREDIENT4R4HFI6D95LANSOPRAZOLE CAPSULE, DELAYED RELEASE [BRECKENRIDGE PHARMACEUTICAL, INC.]4
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HLANSOPRAZOLE CAPSULE, DELAYED RELEASE [BRECKENRIDGE PHARMACEUTICAL, INC.]4
SUCROSEINACTIVE INGREDIENTC151H8M554LANSOPRAZOLE CAPSULE, DELAYED RELEASE [BRECKENRIDGE PHARMACEUTICAL, INC.]4
TALCINACTIVE INGREDIENT7SEV7J4R1ULANSOPRAZOLE CAPSULE, DELAYED RELEASE [BRECKENRIDGE PHARMACEUTICAL, INC.]4
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPLANSOPRAZOLE CAPSULE, DELAYED RELEASE [BRECKENRIDGE PHARMACEUTICAL, INC.]4

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
LansoprazoleLANSOPRAZOLENuCare Pharmaceuticals,Inc.136ad992-2e39-dad9-e063-6294a90adcc62024-03-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201921
application number: ANDA201921

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311277lansoprazole 30 MG Delayed Release Oral CapsulePSNc3d4190d-5583-4121-814e-8c7eff73e1dc13
311277lansoprazole 30 MG Delayed Release Oral CapsuleSCDc3d4190d-5583-4121-814e-8c7eff73e1dc13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
51991-772-335199107723330 CAPSULE, DELAYED RELEASE in 1 BOTTLE (51991-772-33) 2012-12-182021-05-31NoNoCurrent