Lansoprazole

Product NDC
71335-1820
11-digit product format
713351820
Labeler code
71335
Product ID
71335-1820_e66cf5f3-d909-40ad-a03d-c0423f41aa23
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lansoprazole
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA203203
Marketing category
ANDA
Marketing start
2018-08-24
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 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
A203203-001LANSOPRAZOLELANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORALAB2016-07-25
A203203-002LANSOPRAZOLELANSOPRAZOLE30MGCAPSULE, DELAYED REL PELLETS / ORALAB2016-07-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A203203-001AB
A203203-002AB

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 06:07:402026-07A203203-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORALAB2016-07-25caaa826d4ba7…
2026-08-18 06:07:402026-07A203203-002LANSOPRAZOLE30MGCAPSULE, DELAYED REL PELLETS / ORALAB2016-07-25caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A203203-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORALAB2016-07-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203203-002LANSOPRAZOLE30MGCAPSULE, DELAYED REL PELLETS / ORALAB2016-07-25011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203203-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORALAB2016-07-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203203-002LANSOPRAZOLE30MGCAPSULE, DELAYED REL PELLETS / ORALAB2016-07-2531067a03dcf5…
2025-08-23 18:47 UTC2025-08A203203-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORALAB2016-07-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203203-002LANSOPRAZOLE30MGCAPSULE, DELAYED REL PELLETS / ORALAB2016-07-256a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203203-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORALAB2016-07-25fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203203-002LANSOPRAZOLE30MGCAPSULE, DELAYED REL PELLETS / ORALAB2016-07-25fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203203-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORALAB2016-07-25b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203203-002LANSOPRAZOLE30MGCAPSULE, DELAYED REL PELLETS / ORALAB2016-07-25b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203203-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORALAB2016-07-2503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203203-002LANSOPRAZOLE30MGCAPSULE, DELAYED REL PELLETS / ORALAB2016-07-2503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203203-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORALAB2016-07-252680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203203-002LANSOPRAZOLE30MGCAPSULE, DELAYED REL PELLETS / ORALAB2016-07-252680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203203-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORALAB2016-07-255bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203203-002LANSOPRAZOLE30MGCAPSULE, DELAYED REL PELLETS / ORALAB2016-07-255bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203203-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORALAB2016-07-25d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203203-002LANSOPRAZOLE30MGCAPSULE, DELAYED REL PELLETS / ORALAB2016-07-25d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A203203-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORALAB2016-07-25d06236e962d9…
2024-10-29 15:01 UTC2024-10A203203-002LANSOPRAZOLE30MGCAPSULE, DELAYED REL PELLETS / ORALAB2016-07-25d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203203-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORALAB2016-07-2579d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203203-002LANSOPRAZOLE30MGCAPSULE, DELAYED REL PELLETS / ORALAB2016-07-2579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203203-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORALAB2016-07-25301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203203-002LANSOPRAZOLE30MGCAPSULE, DELAYED REL PELLETS / ORALAB2016-07-25301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203203-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORALAB2016-07-251e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203203-002LANSOPRAZOLE30MGCAPSULE, DELAYED REL PELLETS / ORALAB2016-07-251e350fbaab3a…
2024-05-31 18:47 UTC2024-05A203203-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORALAB2016-07-258072bd15b7f6…
2024-05-31 18:47 UTC2024-05A203203-002LANSOPRAZOLE30MGCAPSULE, DELAYED REL PELLETS / ORALAB2016-07-258072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203203-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORALAB2016-07-255c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203203-002LANSOPRAZOLE30MGCAPSULE, DELAYED REL PELLETS / ORALAB2016-07-255c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A203203-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORALAB2016-07-255d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A203203-002LANSOPRAZOLE30MGCAPSULE, DELAYED REL PELLETS / ORALAB2016-07-255d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A203203-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORALAB2016-07-254b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A203203-002LANSOPRAZOLE30MGCAPSULE, DELAYED REL PELLETS / ORALAB2016-07-254b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A203203-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORALAB2016-07-2574a2ff9319b5…
2019-12-13 00:20 UTC2019-12A203203-002LANSOPRAZOLE30MGCAPSULE, DELAYED REL PELLETS / ORALAB2016-07-2574a2ff9319b5…
2022-03-09 01:35 UTC2022-03A203203-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORALAB2016-07-25bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A203203-002LANSOPRAZOLE30MGCAPSULE, DELAYED REL PELLETS / ORALAB2016-07-25bb7c543d1eb4…

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 06:07:402026-07A203203-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A203203-002AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A203203-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203203-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203203-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203203-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A203203-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203203-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203203-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203203-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203203-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203203-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203203-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203203-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203203-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203203-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203203-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203203-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203203-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203203-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A203203-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A203203-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203203-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203203-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203203-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203203-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203203-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203203-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A203203-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A203203-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203203-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203203-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A203203-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A203203-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A203203-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A203203-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A203203-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A203203-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A203203-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A203203-002AB1bb7c543d1eb4…

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
a612a237-ec17-49f0-8985-44407608adb5Available 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
71335-1820-1Lansoprazole30 in 1 BOTTLECAPSULE, DELAYED RELEASE30102
71335-1820-2Lansoprazole90 in 1 BOTTLECAPSULE, DELAYED RELEASE90102
71335-1820-3Lansoprazole18 in 1 BOTTLECAPSULE, DELAYED RELEASE18102
71335-1820-4Lansoprazole28 in 1 BOTTLECAPSULE, DELAYED RELEASE28102
71335-1820-5Lansoprazole56 in 1 BOTTLECAPSULE, DELAYED RELEASE56102
71335-1820-6Lansoprazole58 in 1 BOTTLECAPSULE, DELAYED RELEASE58102
71335-1820-7Lansoprazole60 in 1 BOTTLECAPSULE, DELAYED RELEASE60102
71335-1820-8Lansoprazole180 in 1 BOTTLECAPSULE, DELAYED RELEASE180102
71335-1820-9Lansoprazole120 in 1 BOTTLECAPSULE, DELAYED RELEASE120102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-1820-1EA - Each71335-1820f3d2e160-4aad-4522-8048-292626b3f7f012025-03-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1820LANSOPRAZOLE CAPSULE, DELAYED RELEASE [BRYANT RANCH PREPACK]102Current NDC, Legacy NDC, 9 package rows20231115_a612a237-ec17-49f0-8985-44407608adb5.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 · 12 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LansoprazoleLANSOPRAZOLEPreferred Pharmaceuticals Inc.db42468a-450c-4b12-b2f2-e9a76e976d452026-05-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203203
application number: ANDA203203
LansoprazoleLANSOPRAZOLEA-S Medication Solutions3babf7d9-ad83-4e44-8e5d-f6c11b2d76b62025-09-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203203
application number: ANDA203203
LansoprazoleLANSOPRAZOLEA-S Medication Solutions16dc1e02-4679-4d7f-a65b-6e3706655d352025-09-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203203
application number: ANDA203203
LansoprazoleLANSOPRAZOLENuCare Pharmaceuticals,Inc.37b221ee-b6a4-76e8-e063-6394a90a7e0b2025-06-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203203
application number: ANDA203203
LansoprazoleLANSOPRAZOLEGolden State Medical Supply, Inc.a9dd7e56-1aee-5f0b-e053-2995a90a43bf2024-12-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203203
application number: ANDA203203
LansoprazoleLANSOPRAZOLENuCare Pharmaceuticals,Inc.11344047-7ed4-61e7-e063-6394a90a332d2024-02-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203203
application number: ANDA203203
LansoprazoleLANSOPRAZOLEBryant Ranch Prepacke0299cf2-8a8e-499b-a81e-16e844ea3aff2024-02-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203203
application number: ANDA203203
LansoprazoleLANSOPRAZOLEBryant Ranch Prepackae03d05b-0a0f-4bae-bbdc-450b7b5f7a922024-01-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203203
application number: ANDA203203
LansoprazoleLANSOPRAZOLEBryant Ranch Prepack44f07613-35be-4673-98f0-4b2467acce9c2024-01-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203203
application number: ANDA203203
LansoprazoleLANSOPRAZOLEBryant Ranch Prepack1dc026b6-b521-4a46-9a74-8c1c140d53292024-01-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203203
application number: ANDA203203
LansoprazoleLANSOPRAZOLEBryant Ranch Prepacka612a237-ec17-49f0-8985-44407608adb52023-11-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203203
application number: ANDA203203
ndc (product): 71335-1820
LansoprazoleLANSOPRAZOLEXiromed LLC00a574e0-bd03-deea-9f85-b108f78982ba2022-04-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203203
application number: ANDA203203

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311277lansoprazole 30 MG Delayed Release Oral CapsulePSNa612a237-ec17-49f0-8985-44407608adb5102
311277lansoprazole 30 MG Delayed Release Oral CapsuleSCDa612a237-ec17-49f0-8985-44407608adb5102

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-1820-17133518200130 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-1820-1) 2021-05-050000-00-00NoNoCurrent
71335-1820-27133518200290 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-1820-2) 2021-05-210000-00-00NoNoCurrent
71335-1820-37133518200318 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-1820-3) 2022-07-060000-00-00NoNoCurrent
71335-1820-47133518200428 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-1820-4) 2022-07-060000-00-00NoNoCurrent
71335-1820-57133518200556 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-1820-5) 2022-07-060000-00-00NoNoCurrent
71335-1820-67133518200658 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-1820-6) 2022-07-060000-00-00NoNoCurrent
71335-1820-77133518200760 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-1820-7) 2022-07-060000-00-00NoNoCurrent
71335-1820-871335182008180 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-1820-8) 2022-07-060000-00-00NoNoCurrent
71335-1820-971335182009120 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-1820-9) 2022-07-060000-00-00NoNoCurrent