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NDC 63629-1329-01 Loratadine 10 mg/1 Details
Loratadine 10 mg/1
Loratadine is a ORAL TABLET in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Bryant Ranch Prepack. 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: 63629-1329-01Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Loratadine
Product Information
| NDC | 63629-1329 |
|---|---|
| Product ID | 63629-1329_cd21751e-e62f-40f3-a254-f2db7cf9c101 |
| Associated GPIs | 41550030000320 |
| GCN Sequence Number | 018698 |
| GCN Sequence Number Description | loratadine TABLET 10 MG ORAL |
| HIC3 | Z2Q |
| HIC3 Description | ANTIHISTAMINES - 2ND GENERATION |
| GCN | 60563 |
| HICL Sequence Number | 007605 |
| HICL Sequence Number Description | LORATADINE |
| Brand/Generic | Generic |
| Proprietary Name | Loratadine |
| Proprietary Name Suffix | antihistamine |
| Non-Proprietary Name | Loratadine |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | TABLET |
| Route | ORAL |
| Active Ingredient Strength | 10 |
| Active Ingredient Units | mg/1 |
| Substance Name | LORATADINE |
| Labeler Name | Bryant Ranch Prepack |
| Pharmaceutical Class | n/a |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA076301 |
| Listing Certified Through | 2023-12-31 |
Package
Package Images
NDC 63629-1329-01 (63629132901)
| NDC Package Code | 63629-1329-1 |
|---|---|
| Billing NDC | 63629132901 |
| Package | 20 TABLET in 1 BOTTLE (63629-1329-1) |
| Marketing Start Date | 2022-02-08 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL cd21751e-e62f-40f3-a254-f2db7cf9c101 Details
Uses
Warnings
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.
Directions
Other information
HOW SUPPLIED
NDC: 63629-1329-1: 20 Tablets in a BOTTLE
NDC: 63629-1329-2: 30 Tablets in a BOTTLE
NDC: 63629-1329-3: 60 Tablets in a BOTTLE
NDC: 63629-1329-4: 14 Tablets in a BOTTLE
NDC: 63629-1329-5: 10 Tablets in a BOTTLE
NDC: 63629-1329-6: 90 Tablets in a BOTTLE
NDC: 63629-1329-7: 28 Tablets in a BOTTLE
NDC: 63629-1329-8: 15 Tablets in a BOTTLE
NDC: 63629-1329-9: 100 Tablets in a BOTTLE
INGREDIENTS AND APPEARANCE
| LORATADINE
ANTIHISTAMINE
loratadine tablet |
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| Labeler - Bryant Ranch Prepack (171714327) |
| Registrant - Bryant Ranch Prepack (171714327) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Bryant Ranch Prepack | 171714327 | REPACK(63629-1329) , RELABEL(63629-1329) | |