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Risedronate Sodium

These highlights do not include all the information needed to use safely and effectively. See full prescribing information for . Initial U.S. Approval: 1998

Approved
Approval ID

dddcd321-4d2e-4643-bf3c-7b752b33ba39

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jan 31, 2022

Manufacturers
FDA

Teva Pharmaceuticals USA, Inc.

DUNS: 001627975

Products 3

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

Risedronate Sodium

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code0093-3100
Application NumberANDA077132
Product Classification
M
Marketing Category
C73584
G
Generic Name
Risedronate Sodium
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 31, 2022
FDA Product Classification

INGREDIENTS (11)

STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
HYPROMELLOSE 2910 (5 MPA.S)Inactive
Code: R75537T0T4
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
HYPROMELLOSE 2910 (3 MPA.S)Inactive
Code: 0VUT3PMY82
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UI
Classification: IACT
RISEDRONATE SODIUM MONOHYDRATEActive
Quantity: 30 mg in 1 1
Code: F67L43UT5C
Classification: ACTIR

Risedronate Sodium

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code0093-3098
Application NumberANDA077132
Product Classification
M
Marketing Category
C73584
G
Generic Name
Risedronate Sodium
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 31, 2022
FDA Product Classification

INGREDIENTS (14)

SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
HYPROMELLOSE 2910 (3 MPA.S)Inactive
Code: 0VUT3PMY82
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSE 2910 (5 MPA.S)Inactive
Code: R75537T0T4
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UI
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
RISEDRONATE SODIUM MONOHYDRATEActive
Quantity: 35 mg in 1 1
Code: F67L43UT5C
Classification: ACTIR

Risedronate Sodium

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code0093-3099
Application NumberANDA077132
Product Classification
M
Marketing Category
C73584
G
Generic Name
Risedronate Sodium
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 31, 2022
FDA Product Classification

INGREDIENTS (13)

SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
HYPROMELLOSE 2910 (5 MPA.S)Inactive
Code: R75537T0T4
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
HYPROMELLOSE 2910 (3 MPA.S)Inactive
Code: 0VUT3PMY82
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UI
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
RISEDRONATE SODIUM MONOHYDRATEActive
Quantity: 5 mg in 1 1
Code: F67L43UT5C
Classification: ACTIR

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Risedronate Sodium - FDA Drug Approval Details