Imipramine Hydrochloride
Imipramine Hydrochloride Tablets, USPRx Only
Approved
Approval ID
2f7d5e7f-79aa-4f3a-b9a6-758d9f3ce74d
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 12, 2023
Manufacturers
FDA
Par Pharmaceutical, Inc.
DUNS: 092733690
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Imipramine Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code49884-054
Application NumberANDA088292
Product Classification
M
Marketing Category
C73584
G
Generic Name
Imipramine Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 12, 2023
FDA Product Classification
INGREDIENTS (1)
IMIPRAMINE HYDROCHLORIDEActive
Quantity: 10 mg in 1 1
Code: BKE5Q1J60U
Classification: ACTIB
Imipramine Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code49884-055
Application NumberANDA088262
Product Classification
M
Marketing Category
C73584
G
Generic Name
Imipramine Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 12, 2023
FDA Product Classification
INGREDIENTS (1)
IMIPRAMINE HYDROCHLORIDEActive
Quantity: 25 mg in 1 1
Code: BKE5Q1J60U
Classification: ACTIB
Imipramine Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code49884-056
Application NumberANDA088276
Product Classification
M
Marketing Category
C73584
G
Generic Name
Imipramine Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 12, 2023
FDA Product Classification
INGREDIENTS (1)
IMIPRAMINE HYDROCHLORIDEActive
Quantity: 50 mg in 1 1
Code: BKE5Q1J60U
Classification: ACTIB