tigecycline

Generic: tigecycline

Labeler: sandoz inc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name tigecycline
Generic Name tigecycline
Labeler sandoz inc
Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
INTRAVENOUS PARENTERAL
Active Ingredients

tigecycline 50 mg/10mL

Manufacturer
Sandoz Inc

Identifiers & Regulatory

Product NDC 0781-3481
Product ID 0781-3481_7eeef6bf-1bb2-42d7-9ee2-1a3865b9b11c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA091620
Listing Expiration 2026-12-31
Marketing Start 2017-11-30

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 07813481
Hyphenated Format 0781-3481

Supplemental Identifiers

RxCUI
581531
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 ANDA091620 (source: ndc)
Routes
INTRAVENOUS PARENTERAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/10mL
source: ndc
Packaging
  • 10 VIAL, SINGLE-DOSE in 1 CARTON (0781-3481-92) / 10 mL in 1 VIAL, SINGLE-DOSE (0781-3481-70)
source: ndc

Packages (1)

0781-3481-92 10 VIAL, SINGLE-DOSE in 1 CARTON (0781-3481-92) / 10 mL in 1 VIAL, SINGLE-DOSE (0781-3481-70)

Ingredients (1)

tigecycline (50 mg/10mL)

Linked Drug Pages (1)

Tigecycline ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS", "PARENTERAL"], "spl_id": "7eeef6bf-1bb2-42d7-9ee2-1a3865b9b11c", "openfda": {"nui": ["N0000175938", "M0021223"], "unii": ["70JE2N95KR"], "rxcui": ["581531"], "spl_set_id": ["50605463-2dc2-4b27-bc51-4d87bb9a8539"], "pharm_class_cs": ["Tetracyclines [CS]"], "pharm_class_epc": ["Tetracycline-class Antibacterial [EPC]"], "manufacturer_name": ["Sandoz Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL, SINGLE-DOSE in 1 CARTON (0781-3481-92)  / 10 mL in 1 VIAL, SINGLE-DOSE (0781-3481-70)", "package_ndc": "0781-3481-92", "marketing_start_date": "20171130"}], "brand_name": "Tigecycline", "product_id": "0781-3481_7eeef6bf-1bb2-42d7-9ee2-1a3865b9b11c", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Tetracycline-class Antibacterial [EPC]", "Tetracyclines [CS]"], "product_ndc": "0781-3481", "generic_name": "Tigecycline", "labeler_name": "Sandoz Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Tigecycline", "active_ingredients": [{"name": "TIGECYCLINE", "strength": "50 mg/10mL"}], "application_number": "ANDA091620", "marketing_category": "ANDA", "marketing_start_date": "20171130", "listing_expiration_date": "20261231"}