tobramycin

Generic: tobramycin

Labeler: lupin pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name tobramycin
Generic Name tobramycin
Labeler lupin pharmaceuticals, inc.
Dosage Form SOLUTION
Routes
RESPIRATORY (INHALATION)
Active Ingredients

tobramycin 300 mg/5mL

Manufacturer
Lupin Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 68180-962
Product ID 68180-962_e6e150b5-807d-425e-96f8-345c2a56ee8e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208964
Listing Expiration 2026-12-31
Marketing Start 2018-06-12

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68180962
Hyphenated Format 68180-962

Supplemental Identifiers

RxCUI
348719
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 (source: ndc)
Generic Name tobramycin (source: ndc)
Application Number ANDA208964 (source: ndc)
Routes
RESPIRATORY (INHALATION)
source: ndc

Resolved Composition

Strengths
  • 300 mg/5mL
source: ndc
Packaging
  • 56 POUCH in 1 CARTON (68180-962-56) / 4 AMPULE in 1 POUCH / 5 mL in 1 AMPULE
source: ndc

Packages (1)

68180-962-56 56 POUCH in 1 CARTON (68180-962-56) / 4 AMPULE in 1 POUCH / 5 mL in 1 AMPULE

Ingredients (1)

tobramycin (300 mg/5mL)

Linked Drug Pages (1)

Tobramycin ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["RESPIRATORY (INHALATION)"], "spl_id": "e6e150b5-807d-425e-96f8-345c2a56ee8e", "openfda": {"nui": ["N0000175477", "M0000946"], "unii": ["VZ8RRZ51VK"], "rxcui": ["348719"], "spl_set_id": ["fd871ae7-9083-4e57-aacb-f584c1390db9"], "pharm_class_cs": ["Aminoglycosides [CS]"], "pharm_class_epc": ["Aminoglycoside Antibacterial [EPC]"], "manufacturer_name": ["Lupin Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "56 POUCH in 1 CARTON (68180-962-56)  / 4 AMPULE in 1 POUCH / 5 mL in 1 AMPULE", "package_ndc": "68180-962-56", "marketing_start_date": "20180612"}], "brand_name": "Tobramycin", "product_id": "68180-962_e6e150b5-807d-425e-96f8-345c2a56ee8e", "dosage_form": "SOLUTION", "pharm_class": ["Aminoglycoside Antibacterial [EPC]", "Aminoglycosides [CS]"], "product_ndc": "68180-962", "generic_name": "Tobramycin", "labeler_name": "Lupin Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Tobramycin", "active_ingredients": [{"name": "TOBRAMYCIN", "strength": "300 mg/5mL"}], "application_number": "ANDA208964", "marketing_category": "ANDA", "marketing_start_date": "20180612", "listing_expiration_date": "20261231"}