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NDC 63868-0151-30 Loratadine 10 mg/1 Details
Loratadine 10 mg/1
Loratadine is a ORAL TABLET in the HUMAN OTC DRUG category. It is labeled and distributed by Chain Drug Marketing Association Inc.. 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: 63868-0151-30Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Loratadine
Product Information
| NDC | 63868-0151 |
|---|---|
| Product ID | 63868-151_08f2bf78-eba5-41ce-bcb0-733e2760d44b |
| 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 | n/a |
| Non-Proprietary Name | Loratadine |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | TABLET |
| Route | ORAL |
| Active Ingredient Strength | 10 |
| Active Ingredient Units | mg/1 |
| Substance Name | LORATADINE |
| Labeler Name | Chain Drug Marketing Association Inc. |
| Pharmaceutical Class | n/a |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA076134 |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 63868-0151-30 (63868015130)
| NDC Package Code | 63868-151-30 |
|---|---|
| Billing NDC | 63868015130 |
| Package | 30 TABLET in 1 BLISTER PACK (63868-151-30) |
| Marketing Start Date | 2003-08-19 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL b4edf5b1-398d-405a-8a42-76044b31ebb7 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
PRINCIPAL DISPLAY PANEL - 30 Tablet Blister Pack Carton
QUALITY
CHOICE
NDC 63868-151-30
†Compare to
Active Ingredient in
CLARITIN®
Original Prescription Strength
Allergy Relief
Loratadine Tablets, USP
10 mg | Antihistamine
Indoor & Outdoor Allergies
Relief of:
Sneezing | Runny Nose
Itchy, Watery Eyes | Itchy Throat or Nose
24 Hour Allergy Relief | Non-Drowsy*
30 Tablets
*When taken as directed. See Drug Facts Panel.
INGREDIENTS AND APPEARANCE
| LORATADINE
loratadine tablet |
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| Labeler - Chain Drug Marketing Association Inc. (011920774) |
| Registrant - Ranbaxy Pharmaceuticals Inc. (937890044) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Ohm Laboratories Inc. | 051565745 | manufacture(63868-151) | |