Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
Zydus Pharmaceuticals USA Inc.
156861945
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Zydus Lifesciences Limited
Zydus Pharmaceuticals USA Inc.
Zydus Pharmaceuticals USA Inc.
918596198
Products4
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Ramipril
Product Details
NDC Product Code
68382-145Application Number
ANDA078832Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
November 7, 2023FD&C RED NO. 40Inactive
Code: WZB9127XOAClass: IACT
GELATINInactive
Code: 2G86QN327LClass: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
RamiprilActive
Code: L35JN3I7SJClass: ACTIBQuantity: 2.5 mg in 1 1
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3GClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
Ramipril
Product Details
NDC Product Code
68382-147Application Number
ANDA078832Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
November 7, 2023FD&C BLUE NO. 1Inactive
Code: H3R47K3TBDClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
RamiprilActive
Code: L35JN3I7SJClass: ACTIBQuantity: 10 mg in 1 1
D&C RED NO. 28Inactive
Code: 767IP0Y5NHClass: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3GClass: IACT
GELATINInactive
Code: 2G86QN327LClass: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
Ramipril
Product Details
NDC Product Code
68382-146Application Number
ANDA078832Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
November 7, 2023RamiprilActive
Code: L35JN3I7SJClass: ACTIBQuantity: 5 mg in 1 1
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBDClass: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8Class: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOAClass: IACT
GELATINInactive
Code: 2G86QN327LClass: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
Ramipril
Product Details
NDC Product Code
68382-144Application Number
ANDA078832Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
November 7, 2023FD&C YELLOW NO. 5Inactive
Code: I753WB2F1MClass: IACT
GELATINInactive
Code: 2G86QN327LClass: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
RamiprilActive
Code: L35JN3I7SJClass: ACTIBQuantity: 1.25 mg in 1 1
FD&C RED NO. 40Inactive
Code: WZB9127XOAClass: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8Class: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT