FDA.reportPublic FDA data

Lubiprostone

Product NDC
60687-816
11-digit product format
606870816
Labeler code
60687
Product ID
60687-816_4dc7a17c-dac7-1755-e063-6294a90aa2e0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lubiprostone
Dosage form
CAPSULE, GELATIN COATED
Route
ORAL
Labeler
American Health Packaging
Application
ANDA209920
Marketing category
ANDA
Marketing start
2026-03-18
Substance
LUBIPROSTONE
Active strength
8 ug/1
Pharmacologic classes
Chloride Channel Activator [EPC], Chloride Channel Activators [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
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
A209920-001LUBIPROSTONELUBIPROSTONE8MCGCAPSULE / ORALAB2022-01-18
A209920-002LUBIPROSTONELUBIPROSTONE24MCGCAPSULE / ORALAB2022-01-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A209920-001AB
A209920-002AB

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 22:54:322026-06A209920-001LUBIPROSTONE8MCGCAPSULE / ORALAB2022-01-18a50c72e98297…
2026-08-01 22:54:322026-06A209920-002LUBIPROSTONE24MCGCAPSULE / ORALAB2022-01-18a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A209920-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A209920-002AB1a50c72e98297…

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 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LubiprostoneLUBIPROSTONEProficient Rx LP5fd683a5-87ff-42b8-a8c8-fff81625f67f2026-07-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209920
application number: ANDA209920
LubiprostoneLUBIPROSTONEAmerican Health Packaging3014dd6d-9c05-479d-b79d-7a49f78a1ce52026-03-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209920
application number: ANDA209920
ndc (product): 60687-816
AmitzaLUBIPROSTONEDirect_Rxf2121338-9586-161d-e053-2995a90af9082025-01-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209920
application number: ANDA209920
LubiprostoneLUBIPROSTONETeva Pharmaceuticals, Inc.e17b521e-2c25-4bef-82f9-7916fa79bca42022-05-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209920
application number: ANDA209920

Additional Listing Data#

Finished product
Yes
Brand name base
Lubiprostone
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LUBIPROSTONE8 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
3014dd6d-9c05-479d-b79d-7a49f78a1ce5Available 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
60687-816-32Lubiprostone20 in 1 CARTONCAPSULE, GELATIN COATED204
60687-816-33Lubiprostone1 in 1 BLISTER PACKCAPSULE, GELATIN COATED14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60687-816-32EA - Each60687-8162b50e6e8-66d9-46fd-afc3-f447e9f2e20d12026-04-20
60687-816-33EA - Each60687-816779faf13-4498-42f4-bae6-4de2daf05f3912026-04-20

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
616578lubiprostone 24 MCG Oral CapsulePSN3014dd6d-9c05-479d-b79d-7a49f78a1ce54
794639lubiprostone 8 MCG Oral CapsulePSN3014dd6d-9c05-479d-b79d-7a49f78a1ce54
794639lubiprostone 0.008 MG Oral CapsuleSCD3014dd6d-9c05-479d-b79d-7a49f78a1ce54
616578lubiprostone 0.024 MG Oral CapsuleSCD3014dd6d-9c05-479d-b79d-7a49f78a1ce54
616578lubiprostone 24 MCG Oral CapsuleSY3014dd6d-9c05-479d-b79d-7a49f78a1ce54
794639lubiprostone 8 MCG Oral CapsuleSY3014dd6d-9c05-479d-b79d-7a49f78a1ce54

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
60687-816-326068708163220 BLISTER PACK in 1 CARTON (60687-816-32) / 1 CAPSULE, GELATIN COATED in 1 BLISTER PACK (60687-816-33) 20 blister pack2026-03-18NoNoCurrent
60687-816-33606870816331 in 1 BLISTER PACKHistorical