tobramycin

Generic: tobramycin

Labeler: ascend laboratories, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

tobramycin 300 mg/5mL

Manufacturer
Ascend Laboratories, LLC

Identifiers & Regulatory

Product NDC 67877-678
Product ID 67877-678_25c12569-0ae1-4117-a945-edfc5457e525
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212848
Listing Expiration 2026-12-31
Marketing Start 2021-04-02

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 67877678
Hyphenated Format 67877-678

Supplemental Identifiers

RxCUI
348719
UPC
0367877678702
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 ANDA212848 (source: ndc)
Routes
RESPIRATORY (INHALATION)
source: ndc

Resolved Composition

Strengths
  • 300 mg/5mL
source: ndc
Packaging
  • 56 POUCH in 1 CARTON (67877-678-70) / 7 AMPULE in 1 POUCH (67877-678-69) / 5 mL in 1 AMPULE
source: ndc

Packages (1)

67877-678-70 56 POUCH in 1 CARTON (67877-678-70) / 7 AMPULE in 1 POUCH (67877-678-69) / 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": "25c12569-0ae1-4117-a945-edfc5457e525", "openfda": {"nui": ["N0000175477", "M0000946"], "upc": ["0367877678702"], "unii": ["VZ8RRZ51VK"], "rxcui": ["348719"], "spl_set_id": ["845e3328-fffa-44eb-b78a-3607c05fdd55"], "pharm_class_cs": ["Aminoglycosides [CS]"], "pharm_class_epc": ["Aminoglycoside Antibacterial [EPC]"], "manufacturer_name": ["Ascend Laboratories, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "56 POUCH in 1 CARTON (67877-678-70)  / 7 AMPULE in 1 POUCH (67877-678-69)  / 5 mL in 1 AMPULE", "package_ndc": "67877-678-70", "marketing_start_date": "20210402"}], "brand_name": "Tobramycin", "product_id": "67877-678_25c12569-0ae1-4117-a945-edfc5457e525", "dosage_form": "SOLUTION", "pharm_class": ["Aminoglycoside Antibacterial [EPC]", "Aminoglycosides [CS]"], "product_ndc": "67877-678", "generic_name": "Tobramycin", "labeler_name": "Ascend Laboratories, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Tobramycin", "active_ingredients": [{"name": "TOBRAMYCIN", "strength": "300 mg/5mL"}], "application_number": "ANDA212848", "marketing_category": "ANDA", "marketing_start_date": "20210402", "listing_expiration_date": "20261231"}