FDA.reportPublic FDA data

NDC 0904-5811-46 - lisinopril

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
0904-5811
Requested NDC
0904-5811-46
Package NDCs from labels
0904-5811-61, 0904-5811-43, 0904-5811-80, 0904-5811-89, 0904-5811-46
Manufacturer
Major Pharmaceuticals
Effective date
2018-01-17
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
lisinopril - Major PharmaceuticalsMajor Pharmaceuticals2018-01-17HUMAN PRESCRIPTION DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unitNational Council for Prescription Drug Programs2012-07-24Indexing - Billing Unit

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-5811-43EA - Each0904-581190622b14-7377-45bc-b53d-c7751201f65112012-07-24
0904-5811-46EA - Each0904-58115f181946-3cf1-448b-84b2-d3a3d7b8c26212012-07-24
0904-5811-61EA - Each0904-58117c34fa75-0ca6-42c8-89a2-266d3e1418ba12012-07-24
0904-5811-80EA - Each0904-581115f94d5d-bd8c-4279-a541-146f05d73b7112012-07-24
0904-5811-89EA - Each0904-5811131cb6cf-4828-4ead-b807-80d94bc4a15e12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LISINOPRILACTIVE INGREDIENTE7199S1YWRLISINOPRIL TABLET [MAJOR PHARMACEUTICALS]37
LISINOPRIL ANHYDROUSACTIVE MOIETY7Q3P4BS2FDLISINOPRIL TABLET [MAJOR PHARMACEUTICALS]37
CALCIUM PHOSPHATEINACTIVE INGREDIENT97Z1WI3NDXLISINOPRIL TABLET [MAJOR PHARMACEUTICALS]37
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675LISINOPRIL TABLET [MAJOR PHARMACEUTICALS]37
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTLISINOPRIL TABLET [MAJOR PHARMACEUTICALS]37
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LISINOPRIL TABLET [MAJOR PHARMACEUTICALS]37
MANNITOLINACTIVE INGREDIENT3OWL53L36ALISINOPRIL TABLET [MAJOR PHARMACEUTICALS]37
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJLISINOPRIL TABLET [MAJOR PHARMACEUTICALS]37

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 17 · 326 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LisinoprilLISINOPRILREMEDYREPACK INC.aa5d68e7-c2b9-41eb-ade4-2cd57edc15332026-09-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: E7199S1YWR
CalamineCALAMINE, PRAMOXINE HCLUnited Natural Foods, Inc. dba UNFI0bc1a9b4-1210-4d9a-bbd2-40e9225e86ea2026-09-04Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
CalamineFERRIC OXIDE REDYour Military Exchangesaf95a66c-f063-4019-80c6-6f7dc4fee4d82026-08-28Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
Calamine PlusCALAMINE, PRAMOXINE HYDROCHLORIDEKroger Company44fdd5a4-3cac-15e5-e063-6294a90adb522026-08-26WarningsExact identifier
unii: 1K09F3G675
Bio Combination 28SCHUESSLER SALTSLDD Bioscience Private Limited597caf33-5107-9dec-e063-6294a90a5fcd2026-08-20WarningsExact identifier
unii: 97Z1WI3NDX
Lisinopril and HydrochlorothiazideLISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETSREMEDYREPACK INC.3bea11a3-eb07-46b2-9b91-f8a48a2f3b7e2026-08-11Boxed warning, Warnings, Adverse reactionsExact identifier
unii: E7199S1YWR
CalamineFERRIC OXIDE REDThe Kroger Co.9ddcd6ba-1aed-48f8-a91a-54bd6f0d93082026-08-06Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
LisinoprilLISINOPRILREMEDYREPACK INC.463308ef-16cb-41d8-8d29-6aae2c5a7b0f2026-08-04Boxed warning, Warnings, Adverse reactionsExact identifier
unii: E7199S1YWR
LisinoprilLISINOPRILREMEDYREPACK INC.34bb4602-ccff-4939-91b9-26a63bfd40f72026-08-04Boxed warning, Warnings, Adverse reactionsExact identifier
unii: E7199S1YWR
Lisinopril and HydrochlorothiazideLISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETSProficient Rx LP43a4d6dd-bcca-412c-b051-ed470208ddb62026-08-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: E7199S1YWR
CalamineCALAMINE AND ZINC OXIDEMarie's Original Formulas LLC57110309-9a3d-025f-e063-6394a90a015a2026-07-22WarningsExact identifier
unii: 1K09F3G675
Lisinopril and HydrochlorothiazideLISINOPRIL AND HYDROCHLOROTHIAZIDEAurobindo Pharma Limitedd7214539-6c3d-466a-a474-6fde096fa1822026-07-21Boxed warning, Warnings, Adverse reactionsExact identifier
unii: E7199S1YWR
LisinoprilLISINOPRILAurobindo Pharma Limited0e6364a4-6d66-4151-8197-d45e2a7628952026-07-21Boxed warning, Warnings, Adverse reactionsExact identifier
unii: E7199S1YWR
CalamineCALAMINE AND ZINC OXIDEMarie's Original Formulas LLC571083ce-cd35-a638-e063-6394a90ae4c72026-07-20WarningsExact identifier
unii: 1K09F3G675
LISINOPRILLISINOPRILSt. Mary's Medical Park Pharmacy6051cc96-86e0-bd0b-e053-2a91aa0a5dcf2026-07-17Boxed warning, Warnings, Adverse reactionsExact identifier
unii: E7199S1YWR
CalamineFERRIC OXIDE REDBetter Living Brands, LLCc7ef0ef3-6861-4b94-af4b-371fee8c1f3d2026-07-16Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
LisinoprilLISINOPRILREMEDYREPACK INC.a33d860a-1e17-45b7-aede-51ab3223bebd2026-07-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: E7199S1YWR
LISINOPRILLISINOPRILREMEDYREPACK INC.42f49299-7ae5-4d30-86eb-66b739c0e95d2026-07-14Boxed warning, Warnings, Adverse reactionsExact identifier
unii: E7199S1YWR
LISINOPRILLISINOPRILREMEDYREPACK INC.12d6fe7e-b5a2-4d49-9a06-a6150234d0612026-07-08Boxed warning, Warnings, Adverse reactionsExact identifier
unii: E7199S1YWR
LISINOPRILLISINOPRILCoupler LLC560513ef-4d2c-8ca0-e063-6394a90a674a2026-07-07Boxed warning, Warnings, Adverse reactionsExact identifier
unii: E7199S1YWR

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.