Manufacturing Establishments6
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Microbac Laboratories, Inc.
Prasco Laboratories
178463126
Element Materials Technology Pharma US LLC
Prasco Laboratories
081315325
Patheon Manufacturing Services LLC
Prasco Laboratories
079415560
Triclinic Labs
Prasco Laboratories
017662237
Reckitt Benckiser Healthcare International Ltd.
Prasco Laboratories
230780363
Reading Scientific Services Ltd (RSSL)
Prasco Laboratories
293610085
Products3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Lanthanum carbonate
Product Details
NDC Product Code
66993-423Application Number
NDA021468Marketing Category
NDA authorized generic (C73605)Route of Administration
ORALEffective Date
December 26, 2023Lanthanum carbonateActive
Code: 490D9F069TClass: ACTIMQuantity: 750 mg in 1 1
DEXTRATESInactive
Code: G263MI44RUClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
Lanthanum carbonate
Product Details
NDC Product Code
66993-422Application Number
NDA021468Marketing Category
NDA authorized generic (C73605)Route of Administration
ORALEffective Date
December 26, 2023DEXTRATESInactive
Code: G263MI44RUClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
Lanthanum carbonateActive
Code: 490D9F069TClass: ACTIMQuantity: 500 mg in 1 1
Lanthanum carbonate
Product Details
NDC Product Code
66993-424Application Number
NDA021468Marketing Category
NDA authorized generic (C73605)Route of Administration
ORALEffective Date
December 26, 2023Lanthanum carbonateActive
Code: 490D9F069TClass: ACTIMQuantity: 1000 mg in 1 1
DEXTRATESInactive
Code: G263MI44RUClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT