FDA.reportPublic FDA data

Lubiprostone

Product NDC
70710-1642
11-digit product format
707101642
Labeler code
70710
Product ID
70710-1642_f06e99fa-9894-48ab-99d8-914987dbb73f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lubiprostone
Dosage form
CAPSULE
Route
ORAL
Labeler
Zydus Pharmaceuticals USA Inc.
Application
ANDA214131
Marketing category
ANDA
Marketing start
2023-03-23
Substance
LUBIPROSTONE
Active strength
24 ug/1
Pharmacologic classes
Chloride Channel Activator [EPC], Chloride Channel Activators [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
A214131-001LUBIPROSTONELUBIPROSTONE8MCGCAPSULE / ORALAB2023-03-23
A214131-002LUBIPROSTONELUBIPROSTONE24MCGCAPSULE / ORALAB2023-03-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A214131-001AB
A214131-002AB

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 22:54:322026-06A214131-001LUBIPROSTONE8MCGCAPSULE / ORALAB2023-03-23a50c72e98297…
2026-08-01 22:54:322026-06A214131-002LUBIPROSTONE24MCGCAPSULE / ORALAB2023-03-23a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A214131-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A214131-002AB1a50c72e98297…

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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LubiprostoneLUBIPROSTONEAsclemed USA, Inc.5797e57c-4e87-48d9-b16d-992f64db594f2025-02-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214131
application number: ANDA214131
LubiprostoneLUBIPROSTONEZydus Lifesciences Limited81f9c9de-f89d-4ab0-a8ca-18d3691e42f92024-11-30Exact identifier
application applno (ANDA): 214131
application number: ANDA214131
LubiprostoneLUBIPROSTONEZydus Pharmaceuticals USA Inc.6c11a204-6831-4269-a3c4-1702ed83f74b2023-03-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214131
application number: ANDA214131
ndc (product): 70710-1642

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LUBIPROSTONE24 ug/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
7662KG2R6KInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
616578Internal RxNorm lookup
794639Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
6c11a204-6831-4269-a3c4-1702ed83f74bAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3b517f14-6449-952f-8aaf-98f2ec9051d0Product name320251024

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70710-1642-1Lubiprostone100 in 1 BOTTLECAPSULE1001
70710-1642-6Lubiprostone60 in 1 BOTTLECAPSULE601

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70710-1642-6EA - Each70710-1642b5def7e9-c69a-4c65-91cc-591dfcf0993812023-12-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70710-1642LUBIPROSTONE CAPSULE [ZYDUS PHARMACEUTICALS USA INC.]1Current NDC, 2 package rows20230328_6c11a204-6831-4269-a3c4-1702ed83f74b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
616578lubiprostone 24 MCG Oral CapsulePSN5797e57c-4e87-48d9-b16d-992f64db594f1
616578lubiprostone 24 MCG Oral CapsulePSN6c11a204-6831-4269-a3c4-1702ed83f74b1
794639lubiprostone 8 MCG Oral CapsulePSN5797e57c-4e87-48d9-b16d-992f64db594f1
794639lubiprostone 8 MCG Oral CapsulePSN6c11a204-6831-4269-a3c4-1702ed83f74b1
794639lubiprostone 0.008 MG Oral CapsuleSCD5797e57c-4e87-48d9-b16d-992f64db594f1
794639lubiprostone 0.008 MG Oral CapsuleSCD6c11a204-6831-4269-a3c4-1702ed83f74b1
616578lubiprostone 0.024 MG Oral CapsuleSCD5797e57c-4e87-48d9-b16d-992f64db594f1
616578lubiprostone 0.024 MG Oral CapsuleSCD6c11a204-6831-4269-a3c4-1702ed83f74b1
616578lubiprostone 24 MCG Oral CapsuleSY5797e57c-4e87-48d9-b16d-992f64db594f1
616578lubiprostone 24 MCG Oral CapsuleSY6c11a204-6831-4269-a3c4-1702ed83f74b1
794639lubiprostone 8 MCG Oral CapsuleSY5797e57c-4e87-48d9-b16d-992f64db594f1
794639lubiprostone 8 MCG Oral CapsuleSY6c11a204-6831-4269-a3c4-1702ed83f74b1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70710-1642-170710164201100 CAPSULE in 1 BOTTLE (70710-1642-1) 100 capsule2023-03-23NoNoCurrent
70710-1642-67071016420660 CAPSULE in 1 BOTTLE (70710-1642-6) 60 capsule2023-03-23NoNoCurrent