Prestalia
These highlights do not include all the information needed to use PRESTALIA tablets safely and effectively. See full prescribing information for PRESTALIA. PRESTALIA (perindopril arginine and amlodipine) tablets, for oral use. Initial U.S. Approval: 2015
Approved
Approval ID
eaa2bbbc-5fcc-4f15-a51c-c4e1bf320c90
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 25, 2019
Manufacturers
FDA
Adhera Therapeutics, Inc.
DUNS: 114131113
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
perindopril arginine and amlodipine besylate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code72931-011
Application NumberNDA205003
Product Classification
M
Marketing Category
C73594
G
Generic Name
perindopril arginine and amlodipine besylate
Product Specifications
Route of AdministrationORAL
Effective DateAugust 31, 2019
FDA Product Classification
INGREDIENTS (6)
perindopril arginineActive
Quantity: 7 mg in 1 1
Code: TFT5IM1KGB
Classification: ACTIB
lactose monohydrateInactive
Code: EWQ57Q8I5X
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
amlodipine besylateActive
Quantity: 5 mg in 1 1
Code: 864V2Q084H
Classification: ACTIM
silicon dioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT
perindopril arginine and amlodipine besylate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code72931-010
Application NumberNDA205003
Product Classification
M
Marketing Category
C73594
G
Generic Name
perindopril arginine and amlodipine besylate
Product Specifications
Route of AdministrationORAL
Effective DateAugust 31, 2019
FDA Product Classification
INGREDIENTS (6)
perindopril arginineActive
Quantity: 3.5 mg in 1 1
Code: TFT5IM1KGB
Classification: ACTIB
amlodipine besylateActive
Quantity: 2.5 mg in 1 1
Code: 864V2Q084H
Classification: ACTIM
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
lactose monohydrateInactive
Code: EWQ57Q8I5X
Classification: IACT
silicon dioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT
perindopril arginine and amlodipine besylate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code72931-012
Application NumberNDA205003
Product Classification
M
Marketing Category
C73594
G
Generic Name
perindopril arginine and amlodipine besylate
Product Specifications
Route of AdministrationORAL
Effective DateAugust 31, 2019
FDA Product Classification
INGREDIENTS (6)
perindopril arginineActive
Quantity: 14 mg in 1 1
Code: TFT5IM1KGB
Classification: ACTIB
amlodipine besylateActive
Quantity: 10 mg in 1 1
Code: 864V2Q084H
Classification: ACTIM
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
lactose monohydrateInactive
Code: EWQ57Q8I5X
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
silicon dioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT