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NDC 72888-0029-11 LORATADINE 10 mg/1 Details
LORATADINE 10 mg/1
LORATADINE is a ORAL TABLET, ORALLY DISINTEGRATING in the HUMAN OTC DRUG category. It is labeled and distributed by Advagen Pharma Limited. 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: 72888-0029-11Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Loratadine
Product Information
| NDC | 72888-0029 |
|---|---|
| Product ID | 72888-029_b021e919-4cb9-09f4-e053-2a95a90a4327 |
| Associated GPIs | |
| 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 |
| 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 | Advagen Pharma Limited |
| Pharmaceutical Class | n/a |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA214280 |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 72888-0029-11 (72888002911)
| NDC Package Code | 72888-029-11 |
|---|---|
| Billing NDC | 72888002911 |
| Package | 3 BLISTER PACK in 1 CARTON (72888-029-11) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK |
| Marketing Start Date | 2020-09-10 |
| NDC Exclude Flag | N |
| Pricing Information | |
| Price Per Unit | 0.59737 |
| Pricing Unit | EA |
| Effective Date | 2024-01-17 |
| NDC Description | 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 |
This pricing file, entitled the NADAC (National Average Drug Acquisition
Cost) files, provide
state Medicaid agencies with covered outpatient drug prices by averaging
survey invoice
prices from retail community pharmacies across the United States. These
pharmacies include
independent retail community pharmacies and chain pharmacies. The prices
are updated on a
weekly and monthly basis
Standard Product Labeling (SPL)/Prescribing Information SPL a5699a95-c0a7-43ea-9bab-bbfaba3c8aa5 Details
SPL UNCLASSIFIED SECTION
| Drug Facts | |
| Active ingredient (in each tablet) Purpose | |
| Loratadine USP, 10 mg………………………………….....................Antihistamine | |
| Uses temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: ■ runny nose ■ itchy, watery eyes ■ sneezing ■ itching of the nose or throat | |
| 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 a 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. |
|
| Directions | |
|
|
| adults and children 6 years and over | 1 tablet daily; not more than 1 tablet in 24 hours |
| Children under 6 years of age | ask a doctor |
| Consumers with liver or kidney disease | ask a doctor |
| Other information | |
|
|
| Inactive ingredients | |
| aspartame, colloidal silicon dioxide, crospovidone, magnesium stearate, maize starch, mannitol, microcrystalline cellulose, peppermint flavor, sodium stearyl fumarate | |
| Questions or comments?
Advagen - 888-413-0949 |
|
| Distributed by:
Advagen Pharma Ltd 666 Plainsboro Road Suite 605 Plainsboro, NJ 08536, USA. |
|
|
Manufactured by: Rubicon Research Private Limited Ambernath, Dist: Thane, 421506 India. |
|
SPL UNCLASSIFIED SECTION
PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
| LORATADINE
loratadine tablet, orally disintegrating |
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| Labeler - Advagen Pharma Limited (051627256) |
| Registrant - Rubicon Research Private Limited (918629544) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Rubicon Research Private Limited | 677604197 | manufacture(72888-029) , analysis(72888-029) , pack(72888-029) | |
Revised: 9/2020
Document Id: b021e919-4cb9-09f4-e053-2a95a90a4327
Set id: a5699a95-c0a7-43ea-9bab-bbfaba3c8aa5
Version: 1
Effective Time: 20200925