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NDC 10135-0762-01 Cetirizine Hydrochloride 10 mg/1 Details
Cetirizine Hydrochloride 10 mg/1
Cetirizine Hydrochloride is a ORAL TABLET in the HUMAN OTC DRUG category. It is labeled and distributed by Marlex Pharmaceuticals, Inc. The primary component is CETIRIZINE HYDROCHLORIDE.
Product Information
| NDC | 10135-0762 |
|---|---|
| Product ID | 10135-762_08a1a524-4759-c7f7-e063-6294a90aa57f |
| Associated GPIs | |
| GCN Sequence Number | 017037 |
| GCN Sequence Number Description | cetirizine HCl TABLET 10 MG ORAL |
| HIC3 | Z2Q |
| HIC3 Description | ANTIHISTAMINES - 2ND GENERATION |
| GCN | 49291 |
| HICL Sequence Number | 006544 |
| HICL Sequence Number Description | CETIRIZINE HCL |
| Brand/Generic | Generic |
| Proprietary Name | Cetirizine Hydrochloride |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Cetirizine Hydrochloride |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | TABLET |
| Route | ORAL |
| Active Ingredient Strength | 10 |
| Active Ingredient Units | mg/1 |
| Substance Name | CETIRIZINE HYDROCHLORIDE |
| Labeler Name | Marlex Pharmaceuticals, Inc |
| Pharmaceutical Class | Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA077498 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 10135-0762-01 (10135076201)
| NDC Package Code | 10135-762-01 |
|---|---|
| Billing NDC | 10135076201 |
| Package | 100 TABLET in 1 BOTTLE (10135-762-01) |
| Marketing Start Date | 2022-10-01 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |