tigecycline

Generic: tigecycline

Labeler: eugia us llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name tigecycline
Generic Name tigecycline
Labeler eugia us llc
Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
INTRAVENOUS
Active Ingredients

tigecycline 50 mg/1

Manufacturer
Eugia US LLC

Identifiers & Regulatory

Product NDC 55150-228
Product ID 55150-228_a5262444-a326-478c-a6d6-b515ef3d1219
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA206335
Listing Expiration 2026-12-31
Marketing Start 2019-06-11

Pharmacologic Class

Established (EPC)
tetracycline-class antibacterial [epc]
Chemical Structure
tetracyclines [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 55150228
Hyphenated Format 55150-228

Supplemental Identifiers

RxCUI
581531
UPC
0355150228102
UNII
70JE2N95KR
NUI
N0000175938 M0021223

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 tigecycline (source: ndc)
Generic Name tigecycline (source: ndc)
Application Number ANDA206335 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 10 VIAL, SINGLE-DOSE in 1 CARTON (55150-228-10) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (1)

55150-228-10 10 VIAL, SINGLE-DOSE in 1 CARTON (55150-228-10) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE

Ingredients (1)

tigecycline (50 mg/1)

Linked Drug Pages (1)

Tigecycline ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "a5262444-a326-478c-a6d6-b515ef3d1219", "openfda": {"nui": ["N0000175938", "M0021223"], "upc": ["0355150228102"], "unii": ["70JE2N95KR"], "rxcui": ["581531"], "spl_set_id": ["dd58e0c3-d8a8-4cf2-96f8-9dd08f309579"], "pharm_class_cs": ["Tetracyclines [CS]"], "pharm_class_epc": ["Tetracycline-class Antibacterial [EPC]"], "manufacturer_name": ["Eugia US LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL, SINGLE-DOSE in 1 CARTON (55150-228-10)  / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE", "package_ndc": "55150-228-10", "marketing_start_date": "20190611"}], "brand_name": "Tigecycline", "product_id": "55150-228_a5262444-a326-478c-a6d6-b515ef3d1219", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Tetracycline-class Antibacterial [EPC]", "Tetracyclines [CS]"], "product_ndc": "55150-228", "generic_name": "Tigecycline", "labeler_name": "Eugia US LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Tigecycline", "active_ingredients": [{"name": "TIGECYCLINE", "strength": "50 mg/1"}], "application_number": "ANDA206335", "marketing_category": "ANDA", "marketing_start_date": "20190611", "listing_expiration_date": "20261231"}