Lansoprazole

Product NDC
31722-570
11-digit product format
317220570
Labeler code
31722
Product ID
31722-570_03b7dceb-2128-4324-b068-7f76a2d9887e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lansoprazole
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Camber Pharmaceuticals, Inc.
Application
ANDA203083
Marketing category
ANDA
Marketing start
2020-05-18
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
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
A203083-001LANSOPRAZOLELANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORALAB2020-05-18
A203083-002LANSOPRAZOLELANSOPRAZOLE30MGCAPSULE, DELAYED REL PELLETS / ORALAB2020-05-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A203083-001AB
A203083-002AB

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 2 · 74 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A203083-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORALAB2020-05-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203083-002LANSOPRAZOLE30MGCAPSULE, DELAYED REL PELLETS / ORALAB2020-05-18011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203083-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORALAB2020-05-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203083-002LANSOPRAZOLE30MGCAPSULE, DELAYED REL PELLETS / ORALAB2020-05-1831067a03dcf5…
2025-08-23 18:47 UTC2025-08A203083-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORALAB2020-05-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203083-002LANSOPRAZOLE30MGCAPSULE, DELAYED REL PELLETS / ORALAB2020-05-186a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203083-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORALAB2020-05-18fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203083-002LANSOPRAZOLE30MGCAPSULE, DELAYED REL PELLETS / ORALAB2020-05-18fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203083-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORALAB2020-05-18b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203083-002LANSOPRAZOLE30MGCAPSULE, DELAYED REL PELLETS / ORALAB2020-05-18b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203083-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORALAB2020-05-1803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203083-002LANSOPRAZOLE30MGCAPSULE, DELAYED REL PELLETS / ORALAB2020-05-1803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203083-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORALAB2020-05-182680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203083-002LANSOPRAZOLE30MGCAPSULE, DELAYED REL PELLETS / ORALAB2020-05-182680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203083-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORALAB2020-05-185bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203083-002LANSOPRAZOLE30MGCAPSULE, DELAYED REL PELLETS / ORALAB2020-05-185bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203083-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORALAB2020-05-18d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203083-002LANSOPRAZOLE30MGCAPSULE, DELAYED REL PELLETS / ORALAB2020-05-18d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A203083-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORALAB2020-05-18d06236e962d9…
2024-10-29 15:01 UTC2024-10A203083-002LANSOPRAZOLE30MGCAPSULE, DELAYED REL PELLETS / ORALAB2020-05-18d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203083-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORALAB2020-05-1879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203083-002LANSOPRAZOLE30MGCAPSULE, DELAYED REL PELLETS / ORALAB2020-05-1879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203083-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORALAB2020-05-18301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203083-002LANSOPRAZOLE30MGCAPSULE, DELAYED REL PELLETS / ORALAB2020-05-18301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203083-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORALAB2020-05-181e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203083-002LANSOPRAZOLE30MGCAPSULE, DELAYED REL PELLETS / ORALAB2020-05-181e350fbaab3a…
2024-05-31 18:47 UTC2024-05A203083-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORALAB2020-05-188072bd15b7f6…
2024-05-31 18:47 UTC2024-05A203083-002LANSOPRAZOLE30MGCAPSULE, DELAYED REL PELLETS / ORALAB2020-05-188072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203083-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORALAB2020-05-185c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203083-002LANSOPRAZOLE30MGCAPSULE, DELAYED REL PELLETS / ORALAB2020-05-185c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A203083-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORALAB2020-05-185d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A203083-002LANSOPRAZOLE30MGCAPSULE, DELAYED REL PELLETS / ORALAB2020-05-185d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A203083-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORALAB2020-05-184b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A203083-002LANSOPRAZOLE30MGCAPSULE, DELAYED REL PELLETS / ORALAB2020-05-184b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A203083-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORALAB2020-05-18bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A203083-002LANSOPRAZOLE30MGCAPSULE, DELAYED REL PELLETS / ORALAB2020-05-18bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A203083-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORALAB2020-05-18782e0a99824c…
2021-12-28 21:50 UTC2021-12A203083-002LANSOPRAZOLE30MGCAPSULE, DELAYED REL PELLETS / ORALAB2020-05-18782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A203083-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORALAB2020-05-1887673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A203083-002LANSOPRAZOLE30MGCAPSULE, DELAYED REL PELLETS / ORALAB2020-05-1887673890dc5c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 74 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A203083-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203083-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203083-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203083-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A203083-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203083-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203083-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203083-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203083-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203083-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203083-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203083-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203083-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203083-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203083-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203083-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203083-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203083-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A203083-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A203083-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203083-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203083-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203083-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203083-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203083-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203083-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A203083-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A203083-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203083-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203083-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A203083-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A203083-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A203083-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A203083-002AB14b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A203083-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A203083-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A203083-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A203083-002AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A203083-001AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A203083-002AB187673890dc5c…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LANSOPRAZOLE15 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 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
311277Internal RxNorm lookup
596843Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
03b7dceb-2128-4324-b068-7f76a2d9887eAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
d6b97638-59f4-48e2-8959-569628732c46Product name920210622
8690a824-4bf8-4d1e-b118-2d6dda86bc04Product name220161206

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
31722-570-01Lansoprazole100 in 1 BOTTLECAPSULE, DELAYED RELEASE1001
31722-570-05Lansoprazole500 in 1 BOTTLECAPSULE, DELAYED RELEASE5001
31722-570-10Lansoprazole1000 in 1 BOTTLECAPSULE, DELAYED RELEASE10001
31722-570-30Lansoprazole30 in 1 BOTTLECAPSULE, DELAYED RELEASE301
31722-570-90Lansoprazole90 in 1 BOTTLECAPSULE, DELAYED RELEASE901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
31722-570-30EA - Each31722-57005cda3ec-f91b-48ca-b1dc-b23636f260e712021-03-02
31722-570-90EA - Each31722-570515b3123-2205-4b05-aa69-f0e7d623733a12021-03-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
31722-570LANSOPRAZOLE CAPSULE, DELAYED RELEASE [CAMBER PHARMACEUTICALS, INC.]1Current NDC, Legacy NDC, 5 package rows20200805_03b7dceb-2128-4324-b068-7f76a2d9887e.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 · 6 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LansoprazoleLANSOPRAZOLENuCare Pharmaceuticals,Inc.dfdc9aa0-8612-9127-e053-2a95a90ae7c82026-07-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203083
application number: ANDA203083
LansoprazoleLANSOPRAZOLEQuallent Pharmaceuticals Health LLCcc006372-32d3-4539-921a-6bc9ec496b282025-02-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203083
application number: ANDA203083
LansoprazoleLANSOPRAZOLENuCare Pharmaceuticals,Inc.1bbb8f3a-80bf-b881-e063-6294a90ab4f22025-01-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203083
application number: ANDA203083
LansoprazoleLANSOPRAZOLEBryant Ranch Prepack33fc642c-ad41-410b-9a81-eae456f3fcfb2023-04-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203083
application number: ANDA203083
LansoprazoleLANSOPRAZOLEBryant Ranch Prepack551ae468-1a2d-43d6-a2a8-4e5f26e0f9822023-04-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203083
application number: ANDA203083
LansoprazoleLANSOPRAZOLECamber Pharmaceuticals, Inc.03b7dceb-2128-4324-b068-7f76a2d9887e2020-06-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203083
application number: ANDA203083
ndc (product): 31722-570

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
596843lansoprazole 15 MG Delayed Release Oral CapsulePSN33fc642c-ad41-410b-9a81-eae456f3fcfb100
596843lansoprazole 15 MG Delayed Release Oral CapsulePSN551ae468-1a2d-43d6-a2a8-4e5f26e0f982100
596843lansoprazole 15 MG Delayed Release Oral CapsuleSCD33fc642c-ad41-410b-9a81-eae456f3fcfb100
596843lansoprazole 15 MG Delayed Release Oral CapsuleSCD551ae468-1a2d-43d6-a2a8-4e5f26e0f982100
596843lansoprazole 15 MG Delayed Release Oral CapsulePSN1bbb8f3a-80bf-b881-e063-6294a90ab4f22
596843lansoprazole 15 MG Delayed Release Oral CapsuleSCD1bbb8f3a-80bf-b881-e063-6294a90ab4f22
596843lansoprazole 15 MG Delayed Release Oral CapsulePSN03b7dceb-2128-4324-b068-7f76a2d9887e1
596843lansoprazole 15 MG Delayed Release Oral CapsulePSNdfdc9aa0-8612-9127-e053-2a95a90ae7c81
311277lansoprazole 30 MG Delayed Release Oral CapsulePSN03b7dceb-2128-4324-b068-7f76a2d9887e1
596843lansoprazole 15 MG Delayed Release Oral CapsuleSCD03b7dceb-2128-4324-b068-7f76a2d9887e1
596843lansoprazole 15 MG Delayed Release Oral CapsuleSCDdfdc9aa0-8612-9127-e053-2a95a90ae7c81
311277lansoprazole 30 MG Delayed Release Oral CapsuleSCD03b7dceb-2128-4324-b068-7f76a2d9887e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
31722-570-0131722057001100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (31722-570-01) 2020-05-180000-00-00NoNoCurrent
31722-570-0531722057005500 CAPSULE, DELAYED RELEASE in 1 BOTTLE (31722-570-05) 2020-05-180000-00-00NoNoCurrent
31722-570-10317220570101000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (31722-570-10) 2020-05-180000-00-00NoNoCurrent
31722-570-303172205703030 CAPSULE, DELAYED RELEASE in 1 BOTTLE (31722-570-30) 2020-05-180000-00-00NoNoCurrent
31722-570-903172205709090 CAPSULE, DELAYED RELEASE in 1 BOTTLE (31722-570-90) 2020-05-180000-00-00NoNoCurrent