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LUBIPROSTONE

These highlights do not include all the information needed to use LUBIPROSTONE CAPSULES safely and effectively. See full prescribing information for LUBIPROSTONE CAPSULES. LUBIPROSTONE capsules, for oral use Initial U.S. Approval: 2006

Approved
Approval ID

10c7b62d-6c39-453c-8d9a-2f441725bc3b

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Oct 19, 2023

Manufacturers
FDA

Natco Pharma USA LLC

DUNS: 079590418

Products 2

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

LUBIPROSTONE

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code69339-163
Application NumberNDA021908
Product Classification
M
Marketing Category
C73605
G
Generic Name
LUBIPROSTONE
Product Specifications
Route of AdministrationORAL
Effective DateOctober 20, 2023
FDA Product Classification

INGREDIENTS (7)

LUBIPROSTONEActive
Quantity: 24 ug in 1 1
Code: 7662KG2R6K
Classification: ACTIB
MEDIUM-CHAIN TRIGLYCERIDESInactive
Code: C9H2L21V7U
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT

LUBIPROSTONE

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code69339-162
Application NumberNDA021908
Product Classification
M
Marketing Category
C73605
G
Generic Name
LUBIPROSTONE
Product Specifications
Route of AdministrationORAL
Effective DateOctober 20, 2023
FDA Product Classification

INGREDIENTS (7)

LUBIPROSTONEActive
Quantity: 8 ug in 1 1
Code: 7662KG2R6K
Classification: ACTIB
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
MEDIUM-CHAIN TRIGLYCERIDESInactive
Code: C9H2L21V7U
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT

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LUBIPROSTONE - FDA Drug Approval Details