Search by Drug Name or NDC
NDC 00480-0951-01 Naproxen Sodium 375 mg/1 Details
Naproxen Sodium 375 mg/1
Naproxen Sodium is a ORAL TABLET, FILM COATED, EXTENDED RELEASE in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Teva Pharmaceuticals, Inc.. The primary component is NAPROXEN SODIUM.
Product Information
| NDC | 00480-0951 |
|---|---|
| Product ID | 0480-0951_7bb36843-17db-4442-a31f-9a2637d3e85f |
| Associated GPIs | |
| GCN Sequence Number | 063142 |
| GCN Sequence Number Description | naproxen sodium TBMP 24HR 375 MG ORAL |
| HIC3 | S2B |
| HIC3 Description | NSAIDS, CYCLOOXYGENASE INHIBITOR TYPE ANALGESICS |
| GCN | 98900 |
| HICL Sequence Number | 003726 |
| HICL Sequence Number Description | NAPROXEN SODIUM |
| Brand/Generic | Generic |
| Proprietary Name | Naproxen Sodium |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | naproxen sodium |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | TABLET, FILM COATED, EXTENDED RELEASE |
| Route | ORAL |
| Active Ingredient Strength | 375 |
| Active Ingredient Units | mg/1 |
| Substance Name | NAPROXEN SODIUM |
| Labeler Name | Teva Pharmaceuticals, Inc. |
| Pharmaceutical Class | Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA075416 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 00480-0951-01 (00480095101)
| NDC Package Code | 0480-0951-01 |
|---|---|
| Billing NDC | 00480095101 |
| Package | 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0480-0951-01) |
| Marketing Start Date | 2022-11-01 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |