tigecycline

Generic: tigecycline

Labeler: fresenius kabi usa, llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name tigecycline
Generic Name tigecycline
Labeler fresenius kabi usa, llc
Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
INTRAVENOUS
Active Ingredients

tigecycline 50 mg/5mL

Manufacturer
Fresenius Kabi USA, LLC

Identifiers & Regulatory

Product NDC 63323-960
Product ID 63323-960_0a2a6def-f494-41f8-8125-4296924b1753
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA205645
Listing Expiration 2026-12-31
Marketing Start 2016-12-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 63323960
Hyphenated Format 63323-960

Supplemental Identifiers

RxCUI
581531
UPC
0363323960018
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 NDA205645 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 50 mg/5mL
source: ndc
Packaging
  • 10 VIAL, SINGLE-DOSE in 1 CARTON (63323-960-10) / 5 mL in 1 VIAL, SINGLE-DOSE (63323-960-01)
source: ndc

Packages (1)

63323-960-10 10 VIAL, SINGLE-DOSE in 1 CARTON (63323-960-10) / 5 mL in 1 VIAL, SINGLE-DOSE (63323-960-01)

Ingredients (1)

tigecycline (50 mg/5mL)

Linked Drug Pages (1)

Tigecycline ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "0a2a6def-f494-41f8-8125-4296924b1753", "openfda": {"nui": ["N0000175938", "M0021223"], "upc": ["0363323960018"], "unii": ["70JE2N95KR"], "rxcui": ["581531"], "spl_set_id": ["acf5dbe5-ca75-4300-816f-b3f4625f6e7d"], "pharm_class_cs": ["Tetracyclines [CS]"], "pharm_class_epc": ["Tetracycline-class Antibacterial [EPC]"], "manufacturer_name": ["Fresenius Kabi USA, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL, SINGLE-DOSE in 1 CARTON (63323-960-10)  / 5 mL in 1 VIAL, SINGLE-DOSE (63323-960-01)", "package_ndc": "63323-960-10", "marketing_start_date": "20161201"}], "brand_name": "Tigecycline", "product_id": "63323-960_0a2a6def-f494-41f8-8125-4296924b1753", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Tetracycline-class Antibacterial [EPC]", "Tetracyclines [CS]"], "product_ndc": "63323-960", "generic_name": "Tigecycline", "labeler_name": "Fresenius Kabi USA, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Tigecycline", "active_ingredients": [{"name": "TIGECYCLINE", "strength": "50 mg/5mL"}], "application_number": "NDA205645", "marketing_category": "NDA", "marketing_start_date": "20161201", "listing_expiration_date": "20261231"}