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Propafenone Hydrochloride

These highlights do not include all the information needed to use PROPAFENONE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES safely and effectively. See full prescribing information for PROPAFENONE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES. PROPAFENONE HYDROCHLORIDE extended-release capsules, for oral useInitial U.S. Approval: 1989

Approved
Approval ID

d8cae751-c8f9-48c4-ad4e-7d8a8d5aea28

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Nov 7, 2023

Manufacturers
FDA

TWi Pharmaceuticals, Inc.

DUNS: 658402052

Products 3

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

propafenone

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code24979-086
Application NumberANDA212928
Product Classification
M
Marketing Category
C73584
G
Generic Name
propafenone
Product Specifications
Route of AdministrationORAL
Effective DateJune 20, 2020
FDA Product Classification

INGREDIENTS (11)

PROPAFENONE HYDROCHLORIDEActive
Quantity: 325 mg in 1 1
Code: 33XCH0HOCD
Classification: ACTIB
Potassium HydroxideInactive
Code: WZH3C48M4T
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
HYPROMELLOSE 2910 (3 MPA.S)Inactive
Code: 0VUT3PMY82
Classification: IACT
Magnesium StearateInactive
Code: 70097M6I30
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
Sodium Lauryl SulfateInactive
Code: 368GB5141J
Classification: IACT
Titanium DioxideInactive
Code: 15FIX9V2JP
Classification: IACT
ShellacInactive
Code: 46N107B71O
Classification: IACT
Propylene GlycolInactive
Code: 6DC9Q167V3
Classification: IACT
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT

propafenone

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code24979-085
Application NumberANDA212928
Product Classification
M
Marketing Category
C73584
G
Generic Name
propafenone
Product Specifications
Route of AdministrationORAL
Effective DateJune 20, 2020
FDA Product Classification

INGREDIENTS (11)

PROPAFENONE HYDROCHLORIDEActive
Quantity: 225 mg in 1 1
Code: 33XCH0HOCD
Classification: ACTIB
HYPROMELLOSE 2910 (3 MPA.S)Inactive
Code: 0VUT3PMY82
Classification: IACT
Magnesium StearateInactive
Code: 70097M6I30
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
Sodium Lauryl SulfateInactive
Code: 368GB5141J
Classification: IACT
Titanium DioxideInactive
Code: 15FIX9V2JP
Classification: IACT
Propylene GlycolInactive
Code: 6DC9Q167V3
Classification: IACT
ShellacInactive
Code: 46N107B71O
Classification: IACT
Potassium HydroxideInactive
Code: WZH3C48M4T
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT

propafenone

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code24979-087
Application NumberANDA212928
Product Classification
M
Marketing Category
C73584
G
Generic Name
propafenone
Product Specifications
Route of AdministrationORAL
Effective DateJune 20, 2020
FDA Product Classification

INGREDIENTS (11)

Potassium HydroxideInactive
Code: WZH3C48M4T
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
HYPROMELLOSE 2910 (3 MPA.S)Inactive
Code: 0VUT3PMY82
Classification: IACT
PROPAFENONE HYDROCHLORIDEActive
Quantity: 425 mg in 1 1
Code: 33XCH0HOCD
Classification: ACTIB
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
Magnesium StearateInactive
Code: 70097M6I30
Classification: IACT
Sodium Lauryl SulfateInactive
Code: 368GB5141J
Classification: IACT
Titanium DioxideInactive
Code: 15FIX9V2JP
Classification: IACT
ShellacInactive
Code: 46N107B71O
Classification: IACT
Propylene GlycolInactive
Code: 6DC9Q167V3
Classification: IACT
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT

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Propafenone Hydrochloride - FDA Drug Approval Details