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FDA Approval

Lisinopril

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
BluePoint Laboratories
DUNS: 985523874
Effective Date
June 30, 2021
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Lisinopril(40 mg in 1 1)

Registrants1

Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.

LUPIN LIMITED

675923163

Manufacturing Establishments2

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

Lupin Limited

BluePoint Laboratories

LUPIN LIMITED

650759348

LUPIN LIMITED

BluePoint Laboratories

LUPIN LIMITED

863645527

Products7

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

Lisinopril

Product Details

NDC Product Code
68001-486
Application Number
ANDA077321
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
June 30, 2021
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92JClass: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRTClass: IACT
MANNITOLInactive
Code: 3OWL53L36AClass: IACT
LisinoprilActive
Code: E7199S1YWRClass: ACTIBQuantity: 40 mg in 1 1
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT

Lisinopril

Product Details

NDC Product Code
68001-335
Application Number
ANDA077321
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
June 30, 2021
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92JClass: IACT
MANNITOLInactive
Code: 3OWL53L36AClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675Class: IACT
LisinoprilActive
Code: E7199S1YWRClass: ACTIBQuantity: 20 mg in 1 1

Lisinopril

Product Details

NDC Product Code
68001-332
Application Number
ANDA077321
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
June 30, 2021
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
LisinoprilActive
Code: E7199S1YWRClass: ACTIBQuantity: 2.5 mg in 1 1
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92JClass: IACT
MANNITOLInactive
Code: 3OWL53L36AClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT

Lisinopril

Product Details

NDC Product Code
68001-333
Application Number
ANDA077321
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
June 30, 2021
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92JClass: IACT
MANNITOLInactive
Code: 3OWL53L36AClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675Class: IACT
LisinoprilActive
Code: E7199S1YWRClass: ACTIBQuantity: 5 mg in 1 1

Lisinopril

Product Details

NDC Product Code
68001-337
Application Number
ANDA077321
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
June 30, 2021
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92JClass: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRTClass: IACT
MANNITOLInactive
Code: 3OWL53L36AClass: IACT
LisinoprilActive
Code: E7199S1YWRClass: ACTIBQuantity: 40 mg in 1 1

Lisinopril

Product Details

NDC Product Code
68001-334
Application Number
ANDA077321
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
June 30, 2021
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675Class: IACT
LisinoprilActive
Code: E7199S1YWRClass: ACTIBQuantity: 10 mg in 1 1
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92JClass: IACT
MANNITOLInactive
Code: 3OWL53L36AClass: IACT

Lisinopril

Product Details

NDC Product Code
68001-336
Application Number
ANDA077321
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
June 30, 2021
LisinoprilActive
Code: E7199S1YWRClass: ACTIBQuantity: 30 mg in 1 1
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92JClass: IACT
MANNITOLInactive
Code: 3OWL53L36AClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675Class: IACT
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