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Lisinopril

ONCE-DAILY Lisinopril Tablets USP Revised: September 2008 Rx only  2000258-02

Approved
Approval ID

8d418173-0ec3-4684-8708-0cc65edb664b

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Oct 1, 2010

Manufacturers
FDA

Rebel Distributors Corp

DUNS: 118802834

Products 4

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Lisinopril

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code21695-330
Application NumberANDA076059
Product Classification
M
Marketing Category
C73584
G
Generic Name
Lisinopril
Product Specifications
Route of AdministrationORAL
Effective DateOctober 16, 2008
FDA Product Classification

INGREDIENTS (7)

SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
FD&C YELLOW NO. 5Inactive
Code: I753WB2F1M
Classification: IACT
LISINOPRILActive
Quantity: 20 mg in 1 1
Code: E7199S1YWR
Classification: ACTIB
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92J
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
mannitolInactive
Code: 3OWL53L36A
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT

Lisinopril

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code21695-329
Application NumberANDA076059
Product Classification
M
Marketing Category
C73584
G
Generic Name
Lisinopril
Product Specifications
Route of AdministrationORAL
Effective DateOctober 16, 2008
FDA Product Classification

INGREDIENTS (7)

SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
LISINOPRILActive
Quantity: 10 mg in 1 1
Code: E7199S1YWR
Classification: ACTIB
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92J
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
mannitolInactive
Code: 3OWL53L36A
Classification: IACT

Lisinopril

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code21695-328
Application NumberANDA076059
Product Classification
M
Marketing Category
C73584
G
Generic Name
Lisinopril
Product Specifications
Route of AdministrationORAL
Effective DateOctober 16, 2008
FDA Product Classification

INGREDIENTS (6)

magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
LISINOPRILActive
Quantity: 5 mg in 1 1
Code: E7199S1YWR
Classification: ACTIB
mannitolInactive
Code: 3OWL53L36A
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92J
Classification: IACT

Lisinopril

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code21695-331
Application NumberANDA076059
Product Classification
M
Marketing Category
C73584
G
Generic Name
Lisinopril
Product Specifications
Route of AdministrationORAL
Effective DateOctober 16, 2008
FDA Product Classification

INGREDIENTS (7)

LISINOPRILActive
Quantity: 40 mg in 1 1
Code: E7199S1YWR
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92J
Classification: IACT
FD&C YELLOW NO. 5Inactive
Code: I753WB2F1M
Classification: IACT
mannitolInactive
Code: 3OWL53L36A
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT

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Lisinopril - FDA Drug Approval Details