FDA.reportPublic FDA data

NDC 0781-5077-64 - Loratadine

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
0781-5077
Requested NDC
0781-5077-64
Package NDCs from labels
0781-5077-01, 0781-5077-64
Manufacturer
REMEDYREPACK INC.
Effective date
2020-03-31
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Drug FactsREMEDYREPACK INC.2020-03-31HUMAN OTC DRUG LABEL
Loratadine - Bryant Ranch PrepackBryant Ranch Prepack2020-01-19HUMAN OTC DRUG LABEL
Loratadine - Bryant Ranch PrepackBryant Ranch Prepack2020-01-19HUMAN OTC DRUG LABEL
Loratadine - Sandoz IncSandoz Inc2019-02-15HUMAN OTC DRUG LABEL
Loratadine - St. Mary’s Medical Park PharmacySt. Mary’s Medical Park Pharmacy2018-11-15HUMAN OTC DRUG LABEL
Loratadine - Contract Pharmacy Services-PA | Coupler EnterprisesContract Pharmacy Services-PA | Coupler Enterprises2017-09-19HUMAN OTC DRUG LABEL
Drug FactsNuCare Pharmaceuticals, Inc.2017-05-11HUMAN OTC DRUG LABEL
Loratadine - NCS HealthCare of KY, Inc dba Vangard LabsNCS HealthCare of KY, Inc dba Vangard Labs2014-11-24HUMAN OTC 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
0781-5077-01EA - Each0781-5077ee2bd65b-3fef-4be8-badd-bf30aea9e7c912012-07-24
0781-5077-64EA - Each0781-5077d1533bfe-0d09-41a8-b3de-70ebebf3c12b12012-07-24
0781-5077-76EA - Each0781-50777f0bca63-8292-4908-b293-10884106fc8812013-02-11

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LORATADINEACTIVE INGREDIENT7AJO3BO7QNLORATADINE TABLET [SANDOZ INC]14
LORATADINEACTIVE MOIETY7AJO3BO7QNLORATADINE TABLET [SANDOZ INC]14
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61ULORATADINE TABLET [SANDOZ INC]14
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XLORATADINE TABLET [SANDOZ INC]14
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LORATADINE TABLET [SANDOZ INC]14
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2LORATADINE TABLET [SANDOZ INC]14
LORATADINEACTIVE INGREDIENT7AJO3BO7QNLORATADINE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]6
LORATADINEACTIVE MOIETY7AJO3BO7QNLORATADINE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]6
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61ULORATADINE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]6
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XLORATADINE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]6
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LORATADINE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]6
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2LORATADINE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]6

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 21 · 407 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
childrens allergy reliefLORATADINECVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDbc789b82-56ca-4248-b60a-252d9695636a2026-09-29WarningsExact identifier
unii: 7AJO3BO7QN
childrens allergy reliefLORATADINERite Aid Corporation539336e6-7979-47ed-b1ea-fd46ef547aee2026-09-04WarningsExact identifier
unii: 7AJO3BO7QN
loratadineLORATADINERite Aid Corporation7b804f66-9323-4119-a856-1e6f082807812026-09-04WarningsExact identifier
unii: 7AJO3BO7QN
LoratadineLORATADINEYYBA CORP5a71de5c-a844-9dd4-e063-6294a90af0152026-09-01WarningsExact identifier
rxcui: 311372
unii: 7AJO3BO7QN
perrigo allergy dLORATADINE, PSEUDOEPHEDRINE SULFATEL. Perrigo Company955c9f49-38af-4b48-b325-60fa94bfe60b2026-09-01WarningsExact identifier
unii: 7AJO3BO7QN
Childrens Loratadine Sugar FreeLORATADINESun Pharmaceutical Industries, Inc.58eaab62-ac36-4080-8ded-9b472dddc6172026-08-30WarningsExact identifier
unii: 7AJO3BO7QN
AMAZON BASIC CARE ALLERGY RELIEFLORATADINEAmazon.com Services LLC113da68e-f658-082a-e063-6294a90ad9292026-08-28WarningsExact identifier
rxcui: 311372
unii: 7AJO3BO7QN
childrens allergy reliefLORATADINEAmazon.com Services LLC74bc9e66-2bd0-457f-b2c4-5b4c6a1e689c2026-08-20WarningsExact identifier
unii: 7AJO3BO7QN
All Day Allergy ReliefLORATADINESafeway, Inc.9e581ae1-d1e6-4038-86e8-fd0c5ab9878a2026-08-19WarningsExact identifier
application number: ANDA075209
rxcui: 311372
unii: 7AJO3BO7QN
LoratadineLORATADINEMajor Pharmaceuticals98e41ae1-677a-4583-9a0a-edba29ebbc302026-08-07WarningsExact identifier
rxcui: 311372
unii: 7AJO3BO7QN
Loratadine ODTLORATADINERugby Laboratoriesf59f3400-da77-4eb7-be02-842071d87fae2026-08-07WarningsExact identifier
unii: 7AJO3BO7QN
Dye-Free Childrens LoratadineLORATADINECVS PHARMACY, INC2e75a831-eccc-4179-a4e3-9844be24bcda2026-08-05WarningsExact identifier
unii: 7AJO3BO7QN
Dye-Free Childrens LoratadineLORATADINECVS PHARMACY, INCaf6e6e60-8e39-45a8-bb76-50403aef96682026-08-04WarningsExact identifier
unii: 7AJO3BO7QN
SurviveX Travel Med MODCONVENIENCE KITIntent Brands LLC522da86b-cfd7-dd20-e063-6394a90a51c62026-08-04WarningsExact identifier
rxcui: 311372
allergy reliefLORATADINEWalgreen Company41f8fc1d-2d14-48da-a233-23e9c11296d92026-07-23WarningsExact identifier
rxcui: 311372
unii: 7AJO3BO7QN
Allergy ReliefLORATADINEDr. Reddy's Laboratories Inc.44da36d2-1881-e779-d3a2-13ea828f92402026-07-15WarningsExact identifier
rxcui: 311372
unii: 7AJO3BO7QN
Childrens LoratadineLORATADINESun Pharmaceutical Industries, Inc.12c8066a-3429-481e-b63a-7ea2b439a1702026-07-14WarningsExact identifier
unii: 7AJO3BO7QN
Childrens Loratadine Sugar FreeLORATADINESun Pharmaceutical Industries, Inc.96a76906-58ad-40cd-be27-4ea254e298c52026-07-14WarningsExact identifier
unii: 7AJO3BO7QN
LoratadineLORATADINENuCare Pharmaceuticals, Inc.569a35be-d653-181c-e063-6294a90a6eb92026-07-14WarningsExact identifier
rxcui: 311372
unii: 7AJO3BO7QN
ALLERGY RELIEFLORATADINEMeijer, Inc.190ecdc3-454a-4623-9e4a-09f4ab8650842026-07-09WarningsExact identifier
unii: 7AJO3BO7QN

Reported adverse events (FAERS/openFDA)#

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