Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
PD-Rx Pharmaceuticals, Inc.
156893695
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
PD-Rx Pharmaceuticals, Inc.
PD-Rx Pharmaceuticals, Inc.
PD-Rx Pharmaceuticals, Inc.
156893695
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Lisinopril and Hydrochlorothiazide
Product Details
NDC Product Code
43063-482Application Number
ANDA077912Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
May 10, 2023MANNITOLInactive
Code: 3OWL53L36AClass: IACT
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92JClass: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQKClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
ALUMINUM OXIDEInactive
Code: LMI26O6933Class: IACT
LisinoprilActive
Code: E7199S1YWRClass: ACTIBQuantity: 10 mg in 1 1
HydrochlorothiazideActive
Code: 0J48LPH2THClass: ACTIBQuantity: 12.5 mg in 1 1