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NDC 00135-0577-01 biotene 1.4 mg/g Details
biotene 1.4 mg/g
biotene is a ORAL PASTE in the HUMAN OTC DRUG category. It is labeled and distributed by GlaxoSmithKline Consumer Healthcare Holdings (US) LLC. The primary component is SODIUM MONOFLUOROPHOSPHATE.
Product Information
| NDC | 00135-0577 |
|---|---|
| Product ID | 0135-0577_0a3dc8fe-422b-85fa-e063-6294a90ad359 |
| 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 | biotene |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | sodium monofluorophosphate |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | PASTE |
| Route | ORAL |
| Active Ingredient Strength | 1.4 |
| Active Ingredient Units | mg/g |
| Substance Name | SODIUM MONOFLUOROPHOSPHATE |
| Labeler Name | GlaxoSmithKline Consumer Healthcare Holdings (US) LLC |
| Pharmaceutical Class | n/a |
| DEA Schedule | n/a |
| Marketing Category | OTC MONOGRAPH DRUG |
| Application Number | M022 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 00135-0577-01 (00135057701)
| NDC Package Code | 0135-0577-01 |
|---|---|
| Billing NDC | 00135057701 |
| Package | 1 TUBE in 1 CARTON (0135-0577-01) / 121.9 g in 1 TUBE |
| Marketing Start Date | 2016-09-01 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |