tobramycin inhalation

Generic: tobramycin inhalation

Labeler: prasco, llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA AUTHORIZED GENERIC Inactive Finished

Drug Facts

Product Profile

Brand Name tobramycin inhalation
Generic Name tobramycin inhalation
Labeler prasco, llc
Dosage Form SOLUTION
Routes
RESPIRATORY (INHALATION)
Active Ingredients

tobramycin 300 mg/4mL

Manufacturer
Prasco, LLC

Identifiers & Regulatory

Product NDC 66993-195
Product ID 66993-195_43a62e66-8821-40b6-85dd-0f29fe4adc8c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA AUTHORIZED GENERIC
Application Number NDA201820
Listing Expiration 2026-12-31
Marketing Start 2020-09-15

Pharmacologic Class

Established (EPC)
aminoglycoside antibacterial [epc]
Chemical Structure
aminoglycosides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 66993195
Hyphenated Format 66993-195

Supplemental Identifiers

RxCUI
1314763
UNII
VZ8RRZ51VK
NUI
N0000175477 M0000946

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name tobramycin inhalation (source: ndc)
Generic Name tobramycin inhalation (source: ndc)
Application Number NDA201820 (source: ndc)
Routes
RESPIRATORY (INHALATION)
source: ndc

Resolved Composition

Strengths
  • 300 mg/4mL
source: ndc
Packaging
  • 14 POUCH in 1 CARTON (66993-195-94) / 4 AMPULE in 1 POUCH / 4 mL in 1 AMPULE
source: ndc

Packages (1)

66993-195-94 14 POUCH in 1 CARTON (66993-195-94) / 4 AMPULE in 1 POUCH / 4 mL in 1 AMPULE

Ingredients (1)

tobramycin (300 mg/4mL)

Linked Drug Pages (1)

Tobramycin Inhalation ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["RESPIRATORY (INHALATION)"], "spl_id": "43a62e66-8821-40b6-85dd-0f29fe4adc8c", "openfda": {"nui": ["N0000175477", "M0000946"], "unii": ["VZ8RRZ51VK"], "rxcui": ["1314763"], "spl_set_id": ["b5b51665-c427-42b9-bd6e-6e3c06f650e1"], "pharm_class_cs": ["Aminoglycosides [CS]"], "pharm_class_epc": ["Aminoglycoside Antibacterial [EPC]"], "manufacturer_name": ["Prasco, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "14 POUCH in 1 CARTON (66993-195-94)  / 4 AMPULE in 1 POUCH / 4 mL in 1 AMPULE", "package_ndc": "66993-195-94", "marketing_start_date": "20200915"}], "brand_name": "Tobramycin Inhalation", "product_id": "66993-195_43a62e66-8821-40b6-85dd-0f29fe4adc8c", "dosage_form": "SOLUTION", "pharm_class": ["Aminoglycoside Antibacterial [EPC]", "Aminoglycosides [CS]"], "product_ndc": "66993-195", "generic_name": "tobramycin inhalation", "labeler_name": "Prasco, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Tobramycin Inhalation", "active_ingredients": [{"name": "TOBRAMYCIN", "strength": "300 mg/4mL"}], "application_number": "NDA201820", "marketing_category": "NDA AUTHORIZED GENERIC", "marketing_start_date": "20200915", "listing_expiration_date": "20261231"}