bethkis

Generic: tobramycin

Labeler: chiesi usa, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name bethkis
Generic Name tobramycin
Labeler chiesi usa, inc.
Dosage Form SOLUTION
Routes
RESPIRATORY (INHALATION)
Active Ingredients

tobramycin 300 mg/4mL

Manufacturer
Chiesi USA, Inc.

Identifiers & Regulatory

Product NDC 10122-820
Product ID 10122-820_32442297-00c4-4800-b7c4-1e2e290f3162
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA201820
Listing Expiration 2026-12-31
Marketing Start 2013-04-15

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 10122820
Hyphenated Format 10122-820

Supplemental Identifiers

RxCUI
1314763 1314768
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 bethkis (source: ndc)
Generic Name tobramycin (source: ndc)
Application Number NDA201820 (source: ndc)
Routes
RESPIRATORY (INHALATION)
source: ndc

Resolved Composition

Strengths
  • 300 mg/4mL
source: ndc
Packaging
  • 4 AMPULE in 1 POUCH (10122-820-04) / 4 mL in 1 AMPULE
  • 7 POUCH in 1 CARTON (10122-820-28) / 4 AMPULE in 1 POUCH / 4 mL in 1 AMPULE
  • 14 POUCH in 1 CARTON (10122-820-56) / 4 AMPULE in 1 POUCH / 4 mL in 1 AMPULE
source: ndc

Packages (3)

10122-820-04 4 AMPULE in 1 POUCH (10122-820-04) / 4 mL in 1 AMPULE 10122-820-28 7 POUCH in 1 CARTON (10122-820-28) / 4 AMPULE in 1 POUCH / 4 mL in 1 AMPULE 10122-820-56 14 POUCH in 1 CARTON (10122-820-56) / 4 AMPULE in 1 POUCH / 4 mL in 1 AMPULE

Ingredients (1)

tobramycin (300 mg/4mL)

Linked Drug Pages (1)

BETHKIS ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["RESPIRATORY (INHALATION)"], "spl_id": "32442297-00c4-4800-b7c4-1e2e290f3162", "openfda": {"nui": ["N0000175477", "M0000946"], "unii": ["VZ8RRZ51VK"], "rxcui": ["1314763", "1314768"], "spl_set_id": ["1cd3d47b-025f-4705-9daf-cf07725ec223"], "pharm_class_cs": ["Aminoglycosides [CS]"], "pharm_class_epc": ["Aminoglycoside Antibacterial [EPC]"], "manufacturer_name": ["Chiesi USA, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "4 AMPULE in 1 POUCH (10122-820-04)  / 4 mL in 1 AMPULE", "package_ndc": "10122-820-04", "marketing_start_date": "20130415"}, {"sample": false, "description": "7 POUCH in 1 CARTON (10122-820-28)  / 4 AMPULE in 1 POUCH / 4 mL in 1 AMPULE", "package_ndc": "10122-820-28", "marketing_start_date": "20130415"}, {"sample": false, "description": "14 POUCH in 1 CARTON (10122-820-56)  / 4 AMPULE in 1 POUCH / 4 mL in 1 AMPULE", "package_ndc": "10122-820-56", "marketing_start_date": "20130415"}], "brand_name": "BETHKIS", "product_id": "10122-820_32442297-00c4-4800-b7c4-1e2e290f3162", "dosage_form": "SOLUTION", "pharm_class": ["Aminoglycoside Antibacterial [EPC]", "Aminoglycosides [CS]"], "product_ndc": "10122-820", "generic_name": "tobramycin", "labeler_name": "Chiesi USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "BETHKIS", "active_ingredients": [{"name": "TOBRAMYCIN", "strength": "300 mg/4mL"}], "application_number": "NDA201820", "marketing_category": "NDA", "marketing_start_date": "20130415", "listing_expiration_date": "20261231"}