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Relistor

These highlights do not include all the information needed to use RELISTOR safely and effectively. See full prescribing information for RELISTOR. RELISTOR (methylnaltrexone bromide) tablets, for oral use RELISTOR (methylnaltrexone bromide) injection, for subcutaneous use Initial U.S. Approval: 2008

Approved
Approval ID

c488fb7c-0a5b-487c-b452-996809d1cb99

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Dec 12, 2023

Manufacturers
FDA

Salix Pharmaceuticals, Inc.

DUNS: 793108036

Products 3

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

Methylnaltrexone bromide

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code65649-150
Application NumberNDA208271
Product Classification
M
Marketing Category
C73594
G
Generic Name
Methylnaltrexone bromide
Product Specifications
Route of AdministrationORAL
Effective DateDecember 12, 2023
FDA Product Classification

INGREDIENTS (1)

METHYLNALTREXONE BROMIDEActive
Quantity: 150 mg in 1 1
Code: RFO6IL3D3M
Classification: ACTIB

Methylnaltrexone bromide

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code65649-552
Application NumberNDA021964
Product Classification
M
Marketing Category
C73594
G
Generic Name
Methylnaltrexone bromide
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateDecember 12, 2023
FDA Product Classification

INGREDIENTS (5)

SODIUM CHLORIDEInactive
Quantity: 2.6 mg in 0.4 mL
Code: 451W47IQ8X
Classification: IACT
EDETATE CALCIUM DISODIUMInactive
Quantity: 0.16 mg in 0.4 mL
Code: 25IH6R4SGF
Classification: IACT
WATERInactive
Quantity: 0.4 mL in 0.4 mL
Code: 059QF0KO0R
Classification: IACT
GLYCINE HYDROCHLORIDEInactive
Quantity: 0.12 mg in 0.4 mL
Code: 225ZLC74HX
Classification: IACT
METHYLNALTREXONE BROMIDEActive
Quantity: 8 mg in 0.4 mL
Code: RFO6IL3D3M
Classification: ACTIB

Methylnaltrexone bromide

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code65649-551
Application NumberNDA021964
Product Classification
M
Marketing Category
C73594
G
Generic Name
Methylnaltrexone bromide
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateDecember 12, 2023
FDA Product Classification

INGREDIENTS (5)

SODIUM CHLORIDEInactive
Quantity: 3.9 mg in 0.6 mL
Code: 451W47IQ8X
Classification: IACT
WATERInactive
Quantity: 0.6 mL in 0.6 mL
Code: 059QF0KO0R
Classification: IACT
GLYCINE HYDROCHLORIDEInactive
Quantity: 0.18 mg in 0.6 mL
Code: 225ZLC74HX
Classification: IACT
EDETATE CALCIUM DISODIUMInactive
Quantity: 0.24 mg in 0.6 mL
Code: 25IH6R4SGF
Classification: IACT
METHYLNALTREXONE BROMIDEActive
Quantity: 12 mg in 0.6 mL
Code: RFO6IL3D3M
Classification: ACTIB

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Relistor - FDA Drug Approval Details