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NDC 69452-0363-20 Desloratadine 5 mg/1 Details
Desloratadine 5 mg/1
Desloratadine is a ORAL TABLET, FILM COATED in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Bionpharma Inc.. The primary component is DESLORATADINE.
MedlinePlus Drug Summary
Desloratadine is used in adults and children to relieve hay fever and allergy symptoms, including sneezing; runny nose; and red, itchy, tearing eyes. It is also used to relieve symptoms of urticaria (hives; red, itchy raised areas of the skin), including itching and rash. Desloratadine is in a class of medications called antihistamines. It works by blocking histamine, a substance in the body that causes allergic symptoms.
Related Packages: 69452-0363-20Last Updated: 05/05/2024
MedLinePlus Full Drug Details: Desloratadine
Product Information
| NDC | 69452-0363 |
|---|---|
| Product ID | 69452-363_63a77a01-b991-4f03-8f9f-4dd09c8302c4 |
| Associated GPIs | |
| GCN Sequence Number | 047763 |
| GCN Sequence Number Description | desloratadine TABLET 5 MG ORAL |
| HIC3 | Z2Q |
| HIC3 Description | ANTIHISTAMINES - 2ND GENERATION |
| GCN | 12762 |
| HICL Sequence Number | 021934 |
| HICL Sequence Number Description | DESLORATADINE |
| Brand/Generic | Generic |
| Proprietary Name | Desloratadine |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Desloratadine |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | TABLET, FILM COATED |
| Route | ORAL |
| Active Ingredient Strength | 5 |
| Active Ingredient Units | mg/1 |
| Substance Name | DESLORATADINE |
| Labeler Name | Bionpharma Inc. |
| Pharmaceutical Class | Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA078357 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 69452-0363-20 (69452036320)
| NDC Package Code | 69452-363-20 |
|---|---|
| Billing NDC | 69452036320 |
| Package | 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (69452-363-20) |
| Marketing Start Date | 2023-11-28 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |