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NDC 50382-0023-04 Triple Antibiotic 400; 5; 5000 [iU]/g; mg/g; [iU]/g Details
Triple Antibiotic 400; 5; 5000 [iU]/g; mg/g; [iU]/g
Triple Antibiotic is a TOPICAL OINTMENT in the HUMAN OTC DRUG category. It is labeled and distributed by Galentic Pharma (India) Private Limited. The primary component is BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE.
Product Information
| NDC | 50382-0023 |
|---|---|
| Product ID | 50382-023_ee230c74-5dfe-eea5-e053-2a95a90a4cab |
| 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 | Triple Antibiotic |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Bacitracin Zinc, Neomycin Sulfate, and Polymyxin B Sulfate |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | OINTMENT |
| Route | TOPICAL |
| Active Ingredient Strength | 400; 5; 5000 |
| Active Ingredient Units | [iU]/g; mg/g; [iU]/g |
| Substance Name | BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE |
| Labeler Name | Galentic Pharma (India) Private Limited |
| Pharmaceutical Class | Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS] |
| DEA Schedule | n/a |
| Marketing Category | OTC MONOGRAPH FINAL |
| Application Number | part333B |
| Listing Certified Through | 2023-12-31 |
Package
NDC 50382-0023-04 (50382002304)
| NDC Package Code | 50382-023-04 |
|---|---|
| Billing NDC | 50382002304 |
| Package | 25 PACKET in 1 CARTON (50382-023-04) / .5 g in 1 PACKET |
| Marketing Start Date | 2013-08-07 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |