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NDC 72983-0500-01 Loratadine 5 mg/1 Details
Loratadine 5 mg/1
Loratadine is a ORAL TABLET in the HUMAN OTC DRUG category. It is labeled and distributed by Tenshi Kaizen Pvt Ltd. The primary component is LORATADINE.
MedlinePlus Drug Summary
Loratadine is used to temporarily relieve the symptoms of hay fever (allergy to pollen, dust, or other substances in the air) and other allergies. These symptoms include sneezing, runny nose, and itchy eyes, nose, or throat. Loratadine is also used to treat itching and redness caused by hives. However, loratadine does not prevent hives or other allergic skin reactions. Loratadine is in a class of medications called antihistamines. It works by blocking the action of histamine, a substance in the body that causes allergic symptoms. Loratadine is also available in combination with pseudoephedrine (Sudafed, others). This monograph only includes information about the use of loratadine alone. If you are taking the loratadine and pseudoephedrine combination product, read the information on the package label or ask your doctor or pharmacist for more information.
Related Packages: 72983-0500-01Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Loratadine
Product Information
| NDC | 72983-0500 |
|---|---|
| Product ID | 72983-500_0df0dfde-1f52-4769-e063-6394a90a2f92 |
| Associated GPIs | |
| GCN Sequence Number | n/a |
| GCN Sequence Number Description | n/a |
| HIC3 | n/a |
| HIC3 Description | n/a |
| GCN | n/a |
| HICL Sequence Number | n/a |
| HICL Sequence Number Description | n/a |
| Brand/Generic | n/a |
| Proprietary Name | Loratadine |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Loratadine |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | TABLET |
| Route | ORAL |
| Active Ingredient Strength | 5 |
| Active Ingredient Units | mg/1 |
| Substance Name | LORATADINE |
| Labeler Name | Tenshi Kaizen Pvt Ltd |
| Pharmaceutical Class | n/a |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA212795 |
| Listing Certified Through | 2025-12-31 |
Package
NDC 72983-0500-01 (72983050001)
| NDC Package Code | 72983-500-01 |
|---|---|
| Billing NDC | 72983050001 |
| Package | 1 BLISTER PACK in 1 CARTON (72983-500-01) / 10 TABLET in 1 BLISTER PACK |
| Marketing Start Date | 2021-05-19 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |