Lansoprazole

Product NDC
51079-121
11-digit product format
510790121
Labeler code
51079
Product ID
51079-121_4358ce86-d59d-4864-e063-6394a90a39a5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
lansoprazole
Dosage form
CAPSULE, DELAYED RELEASE PELLETS
Route
ORAL
Labeler
Mylan Institutional Inc.
Application
ANDA090763
Marketing category
ANDA
Marketing start
2009-12-01
Substance
LANSOPRAZOLE
Active strength
30 mg/1
Pharmacologic classes
Inhibition Gastric Acid Secretion [PE], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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

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
A090763-001LANSOPRAZOLELANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORALAB2009-11-10
A090763-002LANSOPRAZOLELANSOPRAZOLE30MGCAPSULE, DELAYED REL PELLETS / ORALAB2009-11-10

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A090763-001AB
A090763-002AB

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 · 86 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A090763-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORALAB2009-11-1084e616aacf4f…
2026-09-14 22:38:342026-08A090763-002LANSOPRAZOLE30MGCAPSULE, DELAYED REL PELLETS / ORALAB2009-11-1084e616aacf4f…
2026-08-18 06:07:402026-07A090763-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORALAB2009-11-10caaa826d4ba7…
2026-08-18 06:07:402026-07A090763-002LANSOPRAZOLE30MGCAPSULE, DELAYED REL PELLETS / ORALAB2009-11-10caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A090763-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORALAB2009-11-10011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090763-002LANSOPRAZOLE30MGCAPSULE, DELAYED REL PELLETS / ORALAB2009-11-10011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090763-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORALAB2009-11-1031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090763-002LANSOPRAZOLE30MGCAPSULE, DELAYED REL PELLETS / ORALAB2009-11-1031067a03dcf5…
2025-08-23 18:47 UTC2025-08A090763-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORALAB2009-11-106a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090763-002LANSOPRAZOLE30MGCAPSULE, DELAYED REL PELLETS / ORALAB2009-11-106a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090763-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORALAB2009-11-10fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090763-002LANSOPRAZOLE30MGCAPSULE, DELAYED REL PELLETS / ORALAB2009-11-10fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090763-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORALAB2009-11-10b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090763-002LANSOPRAZOLE30MGCAPSULE, DELAYED REL PELLETS / ORALAB2009-11-10b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090763-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORALAB2009-11-1003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090763-002LANSOPRAZOLE30MGCAPSULE, DELAYED REL PELLETS / ORALAB2009-11-1003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090763-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORALAB2009-11-102680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090763-002LANSOPRAZOLE30MGCAPSULE, DELAYED REL PELLETS / ORALAB2009-11-102680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090763-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORALAB2009-11-105bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090763-002LANSOPRAZOLE30MGCAPSULE, DELAYED REL PELLETS / ORALAB2009-11-105bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090763-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORALAB2009-11-10d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090763-002LANSOPRAZOLE30MGCAPSULE, DELAYED REL PELLETS / ORALAB2009-11-10d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090763-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORALAB2009-11-10d06236e962d9…
2024-10-29 15:01 UTC2024-10A090763-002LANSOPRAZOLE30MGCAPSULE, DELAYED REL PELLETS / ORALAB2009-11-10d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090763-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORALAB2009-11-1079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090763-002LANSOPRAZOLE30MGCAPSULE, DELAYED REL PELLETS / ORALAB2009-11-1079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090763-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORALAB2009-11-10301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090763-002LANSOPRAZOLE30MGCAPSULE, DELAYED REL PELLETS / ORALAB2009-11-10301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090763-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORALAB2009-11-101e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090763-002LANSOPRAZOLE30MGCAPSULE, DELAYED REL PELLETS / ORALAB2009-11-101e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090763-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORALAB2009-11-108072bd15b7f6…
2024-05-31 18:47 UTC2024-05A090763-002LANSOPRAZOLE30MGCAPSULE, DELAYED REL PELLETS / ORALAB2009-11-108072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090763-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORALAB2009-11-105c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090763-002LANSOPRAZOLE30MGCAPSULE, DELAYED REL PELLETS / ORALAB2009-11-105c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A090763-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORALAB2009-11-105d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A090763-002LANSOPRAZOLE30MGCAPSULE, DELAYED REL PELLETS / ORALAB2009-11-105d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A090763-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORALAB2009-11-104b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A090763-002LANSOPRAZOLE30MGCAPSULE, DELAYED REL PELLETS / ORALAB2009-11-104b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A090763-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORALAB2009-11-1074a2ff9319b5…
2019-12-13 00:20 UTC2019-12A090763-002LANSOPRAZOLE30MGCAPSULE, DELAYED REL PELLETS / ORALAB2009-11-1074a2ff9319b5…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A090763-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A090763-002AB184e616aacf4f…
2026-08-18 06:07:402026-07A090763-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A090763-002AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A090763-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090763-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090763-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090763-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A090763-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090763-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090763-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090763-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090763-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090763-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090763-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090763-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090763-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090763-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090763-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090763-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090763-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090763-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090763-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A090763-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090763-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090763-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090763-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090763-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090763-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090763-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090763-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A090763-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090763-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090763-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A090763-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A090763-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A090763-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A090763-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A090763-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A090763-002AB174a2ff9319b5…

Additional Listing Data#

Finished product
Yes
Brand name base
Lansoprazole
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LANSOPRAZOLE30 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
0K5C5T2QPGInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
311277Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
eea82d0b-6600-4693-a2b8-596a55458f61Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d6b97638-59f4-48e2-8959-569628732c46Product name920210622
8690a824-4bf8-4d1e-b118-2d6dda86bc04Product name220161206

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51079-121-01Lansoprazole1 in 1 BLISTER PACKCAPSULE, DELAYED RELEASE PELLETS118
51079-121-08Lansoprazole80 in 1 CARTONCAPSULE, DELAYED RELEASE PELLETS8018

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51079-121-01EA - Each51079-1211b6149bf-c5dd-43c5-8658-16be337d134212012-07-24
51079-121-08EA - Each51079-12167288d8e-155f-488e-ac60-be5928deeb3e12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LANSOPRAZOLEACTIVE INGREDIENT0K5C5T2QPGLANSOPRAZOLE CAPSULE, DELAYED RELEASE PELLETS [MYLAN INSTITUTIONAL INC.]5
LANSOPRAZOLEACTIVE MOIETY0K5C5T2QPGLANSOPRAZOLE CAPSULE, DELAYED RELEASE PELLETS [MYLAN INSTITUTIONAL INC.]5
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDLANSOPRAZOLE CAPSULE, DELAYED RELEASE PELLETS [MYLAN INSTITUTIONAL INC.]5
FD&C RED NO. 3INACTIVE INGREDIENTPN2ZH5LOQYLANSOPRAZOLE CAPSULE, DELAYED RELEASE PELLETS [MYLAN INSTITUTIONAL INC.]5
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357LANSOPRAZOLE CAPSULE, DELAYED RELEASE PELLETS [MYLAN INSTITUTIONAL INC.]5
GELATININACTIVE INGREDIENT2G86QN327LLANSOPRAZOLE CAPSULE, DELAYED RELEASE PELLETS [MYLAN INSTITUTIONAL INC.]5
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PLANSOPRAZOLE CAPSULE, DELAYED RELEASE PELLETS [MYLAN INSTITUTIONAL INC.]5
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTEDINACTIVE INGREDIENT2165RE0K14LANSOPRAZOLE CAPSULE, DELAYED RELEASE PELLETS [MYLAN INSTITUTIONAL INC.]5
MAGNESIUM CARBONATEINACTIVE INGREDIENT0E53J927NALANSOPRAZOLE CAPSULE, DELAYED RELEASE PELLETS [MYLAN INSTITUTIONAL INC.]5
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AINACTIVE INGREDIENTNX76LV5T8JLANSOPRAZOLE CAPSULE, DELAYED RELEASE PELLETS [MYLAN INSTITUTIONAL INC.]5
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ALANSOPRAZOLE CAPSULE, DELAYED RELEASE PELLETS [MYLAN INSTITUTIONAL INC.]5
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HLANSOPRAZOLE CAPSULE, DELAYED RELEASE PELLETS [MYLAN INSTITUTIONAL INC.]5
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4TLANSOPRAZOLE CAPSULE, DELAYED RELEASE PELLETS [MYLAN INSTITUTIONAL INC.]5
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3LANSOPRAZOLE CAPSULE, DELAYED RELEASE PELLETS [MYLAN INSTITUTIONAL INC.]5
SHELLACINACTIVE INGREDIENT46N107B71OLANSOPRAZOLE CAPSULE, DELAYED RELEASE PELLETS [MYLAN INSTITUTIONAL INC.]5
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4LANSOPRAZOLE CAPSULE, DELAYED RELEASE PELLETS [MYLAN INSTITUTIONAL INC.]5
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJLANSOPRAZOLE CAPSULE, DELAYED RELEASE PELLETS [MYLAN INSTITUTIONAL INC.]5
SUCROSEINACTIVE INGREDIENTC151H8M554LANSOPRAZOLE CAPSULE, DELAYED RELEASE PELLETS [MYLAN INSTITUTIONAL INC.]5
TALCINACTIVE INGREDIENT7SEV7J4R1ULANSOPRAZOLE CAPSULE, DELAYED RELEASE PELLETS [MYLAN INSTITUTIONAL INC.]5
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPLANSOPRAZOLE CAPSULE, DELAYED RELEASE PELLETS [MYLAN INSTITUTIONAL INC.]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51079-121LANSOPRAZOLE CAPSULE, DELAYED RELEASE PELLETS [MYLAN INSTITUTIONAL INC.]16Current NDC, Legacy NDC, 2 package rows20250403_eea82d0b-6600-4693-a2b8-596a55458f61.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 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LansoprazoleLANSOPRAZOLEPreferred Pharmaceuticals Inc.7a79feee-2e21-4cd0-a720-c596437643032026-08-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090763
application number: ANDA090763
LansoprazoleLANSOPRAZOLESafecor Health LLC47a8618c-e768-41bf-9116-634b564405d42026-06-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090763
application number: ANDA090763
LansoprazoleLANSOPRAZOLEMylan Institutional Inc.eea82d0b-6600-4693-a2b8-596a55458f612025-11-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090763
application number: ANDA090763
ndc (product): 51079-121
LansoprazoleLANSOPRAZOLEMylan Pharmaceuticals Inc.c8fa7401-907f-41b6-a2e1-f4bc214f2cdf2024-09-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090763
application number: ANDA090763

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311277lansoprazole 30 MG Delayed Release Oral CapsulePSNeea82d0b-6600-4693-a2b8-596a55458f6118
311277lansoprazole 30 MG Delayed Release Oral CapsuleSCDeea82d0b-6600-4693-a2b8-596a55458f6118

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51079-121-01510790121011 in 1 BLISTER PACKHistorical
51079-121-085107901210880 BLISTER PACK in 1 CARTON (51079-121-08) / 1 CAPSULE, DELAYED RELEASE PELLETS in 1 BLISTER PACK (51079-121-01) 80 blister pack2009-12-010000-00-00NoNoCurrent