FDA.reportPublic FDA data

Lubiprostone

Product NDC
31722-403
11-digit product format
317220403
Labeler code
31722
Product ID
31722-403_5008a4ec-08c5-4d06-bac9-e7239620a07d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
lubiprostone
Dosage form
CAPSULE
Route
ORAL
Labeler
Camber Pharmaceuticals, Inc.
Application
ANDA218640
Marketing category
ANDA
Marketing start
2025-05-27
Substance
LUBIPROSTONE
Active strength
.008 mg/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
A218640-001LUBIPROSTONELUBIPROSTONE8MCGCAPSULE / ORALAB2025-01-02
A218640-002LUBIPROSTONELUBIPROSTONE24MCGCAPSULE / ORALAB2025-01-02

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A218640-001AB
A218640-002AB

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 22:54:322026-06A218640-001LUBIPROSTONE8MCGCAPSULE / ORALAB2025-01-02a50c72e98297…
2026-08-01 22:54:322026-06A218640-002LUBIPROSTONE24MCGCAPSULE / ORALAB2025-01-02a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A218640-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A218640-002AB1a50c72e98297…

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LubiprostoneLUBIPROSTONENorthstar Rx LLC1626ac65-ea12-421b-9780-bfdb50a39e1a2025-06-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 218640
application number: ANDA218640
LubiprostoneLUBIPROSTONECamber Pharmaceuticals, Inc.6d973d7d-a43e-4495-b618-a8ad3142683d2025-01-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 218640
application number: ANDA218640
ndc (product): 31722-403

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LUBIPROSTONE.008 mg/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
6d973d7d-a43e-4495-b618-a8ad3142683dAvailable 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
31722-403-60Lubiprostone60 in 1 BOTTLECAPSULE601

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
31722-403-60EA - Each31722-4035fdeba01-1d6c-427f-b40e-5dbbce9049c612025-07-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
31722-403LUBIPROSTONE CAPSULE [CAMBER PHARMACEUTICALS, INC.]1Current NDC, 1 package rows20250528_6d973d7d-a43e-4495-b618-a8ad3142683d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
616578lubiprostone 24 MCG Oral CapsulePSN6d973d7d-a43e-4495-b618-a8ad3142683d1
794639lubiprostone 8 MCG Oral CapsulePSN6d973d7d-a43e-4495-b618-a8ad3142683d1
794639lubiprostone 0.008 MG Oral CapsuleSCD6d973d7d-a43e-4495-b618-a8ad3142683d1
616578lubiprostone 0.024 MG Oral CapsuleSCD6d973d7d-a43e-4495-b618-a8ad3142683d1
616578lubiprostone 24 MCG Oral CapsuleSY6d973d7d-a43e-4495-b618-a8ad3142683d1
794639lubiprostone 8 MCG Oral CapsuleSY6d973d7d-a43e-4495-b618-a8ad3142683d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
31722-403-603172204036060 CAPSULE in 1 BOTTLE (31722-403-60) 60 capsule2025-05-27NoNoCurrent