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NDC 46122-0539-65 Loratadine ODT 10 mg/1 Details
Loratadine ODT 10 mg/1
Loratadine ODT is a ORAL TABLET, ORALLY DISINTEGRATING in the HUMAN OTC DRUG category. It is labeled and distributed by Amerisource Bergen. 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: 46122-0539-65Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Loratadine
Product Information
NDC | 46122-0539 |
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Product ID | 46122-539_64ce24cf-4a83-4d87-a5c8-0e9a7589fb13 |
Associated GPIs | 41550030007220 |
GCN Sequence Number | 030476 |
GCN Sequence Number Description | loratadine TAB RAPDIS 10 MG ORAL |
HIC3 | Z2Q |
HIC3 Description | ANTIHISTAMINES - 2ND GENERATION |
GCN | 60521 |
HICL Sequence Number | 007605 |
HICL Sequence Number Description | LORATADINE |
Brand/Generic | Generic |
Proprietary Name | Loratadine ODT |
Proprietary Name Suffix | n/a |
Non-Proprietary Name | Loratadine |
Product Type | HUMAN OTC DRUG |
Dosage Form | TABLET, ORALLY DISINTEGRATING |
Route | ORAL |
Active Ingredient Strength | 10 |
Active Ingredient Units | mg/1 |
Substance Name | LORATADINE |
Labeler Name | Amerisource Bergen |
Pharmaceutical Class | n/a |
DEA Schedule | n/a |
Marketing Category | ANDA |
Application Number | ANDA208477 |
Listing Certified Through | 2024-12-31 |
Package
NDC 46122-0539-65 (46122053965)
NDC Package Code | 46122-539-65 |
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Billing NDC | 46122053965 |
Package | 3 BLISTER PACK in 1 CARTON (46122-539-65) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK |
Marketing Start Date | 2022-08-10 |
NDC Exclude Flag | N |
Pricing Information | |
Price Per Unit | 0.59737 |
Pricing Unit | EA |
Effective Date | 2024-01-17 |
NDC Description | GNP LORATADINE 10 MG ODT |
Pharmacy Type Indicator | C/I |
OTC | Y |
Explanation Code | 4 |
Classification for Rate Setting | G |
As of Date | 2024-02-21 |