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NDC 58602-0703-53 Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride 5; 120 mg/1; mg/1 Details
Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride 5; 120 mg/1; mg/1
Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride is a ORAL TABLET, FILM COATED, EXTENDED RELEASE in the HUMAN OTC DRUG category. It is labeled and distributed by Aurohealth LLC. The primary component is CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE.
MedlinePlus Drug Summary
Cetirizine injection is used to treat acute urticaria in adults and children 6 months of age or older. Cetirizine 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.
Related Packages: 58602-0703-53Last Updated: 04/21/2024
MedLinePlus Full Drug Details: Cetirizine Injection
Pseudoephedrine is used to relieve nasal congestion caused by colds, allergies, and hay fever. It is also used to temporarily relieve sinus congestion and pressure. Pseudoephedrine will relieve symptoms but will not treat the cause of the symptoms or speed recovery. Pseudoephedrine is in a class of medications called nasal decongestants. It works by causing narrowing of the blood vessels in the nasal passages.
Related Packages: 58602-0703-53Last Updated: 04/21/2024
MedLinePlus Full Drug Details: Pseudoephedrine
Product Information
| NDC | 58602-0703 |
|---|---|
| Product ID | 58602-703_4f6fe4bd-b825-44a1-8264-74c664f76746 |
| Associated GPIs | |
| GCN Sequence Number | n/a |
| GCN Sequence Number Description | n/a |
| HIC3 | n/a |
| HIC3 Description | n/a |
| GCN | n/a |
| HICL Sequence Number | n/a |
| HICL Sequence Number Description | n/a |
| Brand/Generic | n/a |
| Proprietary Name | Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | TABLET, FILM COATED, EXTENDED RELEASE |
| Route | ORAL |
| Active Ingredient Strength | 5; 120 |
| Active Ingredient Units | mg/1; mg/1 |
| Substance Name | CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE |
| Labeler Name | Aurohealth LLC |
| Pharmaceutical Class | Adrenergic alpha-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], alpha-Adrenergic Agonist [EPC] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA212409 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 58602-0703-53 (58602070353)
| NDC Package Code | 58602-703-53 |
|---|---|
| Billing NDC | 58602070353 |
| Package | 12 BLISTER PACK in 1 CARTON (58602-703-53) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK |
| Marketing Start Date | 2023-03-08 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |