tigecycline

Generic: tigecycline

Labeler: apotex corp
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name tigecycline
Generic Name tigecycline
Labeler apotex corp
Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
INTRAVENOUS
Active Ingredients

tigecycline 50 mg/5mL

Manufacturer
Apotex Corp

Identifiers & Regulatory

Product NDC 60505-6098
Product ID 60505-6098_d4e75cae-c197-e995-7903-2d41c6c1371d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204439
Listing Expiration 2027-12-31
Marketing Start 2019-04-09

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 605056098
Hyphenated Format 60505-6098

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 ANDA204439 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 50 mg/5mL
source: ndc
Packaging
  • 10 VIAL, SINGLE-USE in 1 CARTON (60505-6098-1) / 5 mL in 1 VIAL, SINGLE-USE
source: ndc

Packages (1)

60505-6098-1 10 VIAL, SINGLE-USE in 1 CARTON (60505-6098-1) / 5 mL in 1 VIAL, SINGLE-USE

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": "d4e75cae-c197-e995-7903-2d41c6c1371d", "openfda": {"nui": ["N0000175938", "M0021223"], "unii": ["70JE2N95KR"], "rxcui": ["581531"], "spl_set_id": ["230484a8-408c-dcc1-d0c4-d9dd9a46831b"], "pharm_class_cs": ["Tetracyclines [CS]"], "pharm_class_epc": ["Tetracycline-class Antibacterial [EPC]"], "manufacturer_name": ["Apotex Corp"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL, SINGLE-USE in 1 CARTON (60505-6098-1)  / 5 mL in 1 VIAL, SINGLE-USE", "package_ndc": "60505-6098-1", "marketing_start_date": "20190409"}], "brand_name": "Tigecycline", "product_id": "60505-6098_d4e75cae-c197-e995-7903-2d41c6c1371d", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Tetracycline-class Antibacterial [EPC]", "Tetracyclines [CS]"], "product_ndc": "60505-6098", "generic_name": "TIGECYCLINE", "labeler_name": "Apotex Corp", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Tigecycline", "active_ingredients": [{"name": "TIGECYCLINE", "strength": "50 mg/5mL"}], "application_number": "ANDA204439", "marketing_category": "ANDA", "marketing_start_date": "20190409", "listing_expiration_date": "20271231"}