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NDC 42571-0408-92 Tobramycin 300 mg/5mL Details
Tobramycin 300 mg/5mL
Tobramycin is a RESPIRATORY (INHALATION) INHALANT in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Micro Labs Limited. The primary component is TOBRAMYCIN.
Product Information
| NDC | 42571-0408 |
|---|---|
| Product ID | 42571-408_01d5a13f-7719-b208-e063-6294a90a560b |
| 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 | Tobramycin |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Tobramycin solution |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | INHALANT |
| Route | RESPIRATORY (INHALATION) |
| Active Ingredient Strength | 300 |
| Active Ingredient Units | mg/5mL |
| Substance Name | TOBRAMYCIN |
| Labeler Name | Micro Labs Limited |
| Pharmaceutical Class | Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA217344 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 42571-0408-92 (42571040892)
| NDC Package Code | 42571-408-92 |
|---|---|
| Billing NDC | 42571040892 |
| Package | 14 POUCH in 1 CARTON (42571-408-92) / 4 AMPULE in 1 POUCH (42571-408-19) / 5 mL in 1 AMPULE (42571-408-09) |
| Marketing Start Date | 2024-01-01 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |