Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
Baxter Healthcare Corporation
005083209
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
BAXTER PHARMACEUTICALS INDIA PRIVATE LIMITED
Baxter Healthcare Corporation
Baxter Healthcare Corporation
918603338
Products6
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
FUROSEMIDE
Product Details
NDC Product Code
36000-063Application Number
ANDA202747Marketing Category
ANDA (C73584)Route of Administration
INTRAVENOUSEffective Date
October 27, 2018FurosemideActive
Code: 7LXU5N7ZO5Class: ACTIBQuantity: 10 mg in 1 mL
WATERInactive
Code: 059QF0KO0RClass: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CBClass: IACT
FUROSEMIDE
Product Details
NDC Product Code
36000-282Application Number
ANDA202747Marketing Category
ANDA (C73584)Route of Administration
INTRAVENOUSEffective Date
October 27, 2018WATERInactive
Code: 059QF0KO0RClass: IACT
FurosemideActive
Code: 7LXU5N7ZO5Class: ACTIBQuantity: 10 mg in 1 mL
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CBClass: IACT
FUROSEMIDE
Product Details
NDC Product Code
36000-283Application Number
ANDA202747Marketing Category
ANDA (C73584)Route of Administration
INTRAVENOUSEffective Date
October 27, 2018WATERInactive
Code: 059QF0KO0RClass: IACT
FurosemideActive
Code: 7LXU5N7ZO5Class: ACTIBQuantity: 10 mg in 1 mL
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CBClass: IACT
FUROSEMIDE
Product Details
NDC Product Code
36000-065Application Number
ANDA202747Marketing Category
ANDA (C73584)Route of Administration
INTRAVENOUSEffective Date
October 27, 2018FurosemideActive
Code: 7LXU5N7ZO5Class: ACTIBQuantity: 10 mg in 1 mL
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CBClass: IACT
FUROSEMIDE
Product Details
NDC Product Code
36000-284Application Number
ANDA202747Marketing Category
ANDA (C73584)Route of Administration
INTRAVENOUSEffective Date
October 27, 2018SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CBClass: IACT
FurosemideActive
Code: 7LXU5N7ZO5Class: ACTIBQuantity: 10 mg in 1 mL
WATERInactive
Code: 059QF0KO0RClass: IACT
FUROSEMIDE
Product Details
NDC Product Code
36000-064Application Number
ANDA202747Marketing Category
ANDA (C73584)Route of Administration
INTRAVENOUSEffective Date
October 27, 2018HYDROCHLORIC ACIDInactive
Code: QTT17582CBClass: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
FurosemideActive
Code: 7LXU5N7ZO5Class: ACTIBQuantity: 10 mg in 1 mL
WATERInactive
Code: 059QF0KO0RClass: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACT