FDA.reportPublic FDA data

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 1.

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A203203-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORALAB2016-07-25a50c72e98297…
2026-08-01 22:54:322026-06A203203-002LANSOPRAZOLE30MGCAPSULE, DELAYED REL PELLETS / ORALAB2016-07-25a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A203203-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A203203-002AB1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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

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

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