FDA.reportPublic FDA data

Loratadine

Product NDC
51655-027
11-digit product format
516550027
Labeler code
51655
Product ID
51655-027_0f7228b0-773b-4355-b439-b6b6f5bd1659
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Loratadine
Dosage form
TABLET
Route
ORAL
Labeler
Northwind Pharmaceuticals, LLC
Application
ANDA076134
Marketing category
ANDA
Marketing start
2014-10-27
Marketing end
0000-00-00
Substance
LORATADINE
Active strength
10 mg/1
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct51655-027DDiscontinued by firm2026-07-31
excluded packagepackage51655-02751655-027-26DDiscontinued by firm2026-07-31

Orange Book products#

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A076134-001LORATADINELORATADINE10MGTABLET / ORAL2003-08-18

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LoratadineLORATADINECardinal Health 107, LLC64489b01-a4a7-4c6d-ac84-1dfbd1388d842026-06-04WarningsExact identifier
MEDIQUE LoradamedLORATADINESportpharm LLCd6bf0e68-f87c-49ee-a15d-df7f5bfa62212026-04-24WarningsExact identifier
Loratadine Allergy ReliefLORATADINEPD-Rx Pharmaceuticals, Inc.7127b39d-3686-4249-b720-43c02b4c46542026-03-19WarningsExact identifier
Loratadine Allergy ReliefLORATADINEA-S Medication Solutionsa53e5635-8633-4c28-b04f-cdfb3d851e682026-02-19WarningsExact identifier
Green Guard 24 Hour Allergy ReliefLORATADINEUnifirst First Aid Corporation32092beb-c177-4b6b-afa4-b4b5d64621f42025-11-21WarningsExact identifier
Loratadine Allergy ReliefLORATADINEMarlex Pharmaceuticals, Inc.ec08a6ee-3d71-0fa9-e053-2995a90a9cb12025-11-18WarningsExact identifier
McKesson LoratadineLORATADINE 10 MGMcKesson Medical Surgicalc6a3056e-792e-52a4-e053-2a95a90a83612025-10-23WarningsExact identifier
Loratadine Allergy ReliefLORATADINEAsclemed USA, Inc.332bda00-1350-2d33-e063-6394a90a8bd72025-05-21WarningsExact identifier
Loratadine Allergy ReliefLORATADINEA-S Medication Solutions0be70365-57ee-4f2e-a30f-bdd5c292992d2025-02-20WarningsExact identifier
Loratadine Allergy ReliefLORATADINEA-S Medication Solutionsbaaf9c23-0b54-46a2-8aec-13264479a6d72025-02-20WarningsExact identifier
LoratadineLORATADINEAmerican Health Packaging411f3692-99ff-49d7-8594-e6f404f5861f2024-11-21WarningsExact identifier
Loratadine Allergy ReliefLORATADINEProficient Rx LPa6b9a1bf-1013-4a15-b3b2-a226a75a1ffb2024-10-01WarningsExact identifier
Loratadine Allergy ReliefLORATADINEBryant Ranch Prepack40914eeb-3a85-4691-9fb8-2df72ba1f7092024-04-05WarningsExact identifier
Loratadine Allergy ReliefLORATADINEBryant Ranch Prepack94642b79-f91a-429f-87f4-dad326d4f3ed2024-04-03WarningsExact identifier
Loratadine Allergy ReliefLORATADINEOHM LABORATORIES INC.c35f2cc1-f76d-4824-b0a5-747bca0c3b852023-12-08WarningsExact identifier
Handy Solutions 24 Hour AllergyLORATADINENavajo Manufacturing Company Inc.67263031-9095-48f2-8b34-e589b28a74162023-03-15WarningsExact identifier
LoratadineLORATADINESAFEWAY INC.1092b8af-25f2-4c25-b3bc-5ffb14e960242021-12-21WarningsExact identifier
LoratadineLORATADINECVS Pharmacye63f082c-ff50-43ed-ad2c-598b352413e82021-12-21WarningsExact identifier
Loratadine Allergy ReliefLORATADINEDISCOUNT DRUG MART55d3ee36-116b-4ec6-b409-79d67a2b54ae2018-09-14WarningsExact identifier
Loratadine Allergy ReliefLORATADINEWinCo Foods, LLC506a60e8-7fec-4bb0-babc-204058ae120f2018-08-29WarningsExact identifier

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

warnings

Warnings Do not use if you have ever had an allergic reaction to this product or any of its ingredients. Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose. When using this product do not take more than directed. Taking more than directed may cause drowsiness. Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51655-027-262026-01-07C16284748780-19d75b9d1-14e5-f424-e053-dadaa90a57ceLoratadine
51655-027-262020-01-31C16284748780-19d75b9d1-14e5-f424-e053-dadaa90a57ceLoratadine

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51655-027LORATADINE TABLET [NORTHWIND PHARMACEUTICALS, LLC]1Legacy NDC20160527_c45c1dba-ba6c-4dfb-a1ee-c5ec61ad4dfb.zip