tigecycline

Generic: tigecycline

Labeler: meitheal pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name tigecycline
Generic Name tigecycline
Labeler meitheal pharmaceuticals inc.
Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
INTRAVENOUS
Active Ingredients

tigecycline 50 mg/5mL

Manufacturer
Meitheal Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 71288-019
Product ID 71288-019_944a7489-75b7-4841-a189-1bb66fa83e30
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA214020
Listing Expiration 2026-12-31
Marketing Start 2021-05-13

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 71288019
Hyphenated Format 71288-019

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 ANDA214020 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 50 mg/5mL
source: ndc
Packaging
  • 10 VIAL, SINGLE-DOSE in 1 CARTON (71288-019-11) / 5 mL in 1 VIAL, SINGLE-DOSE (71288-019-10)
source: ndc

Packages (1)

71288-019-11 10 VIAL, SINGLE-DOSE in 1 CARTON (71288-019-11) / 5 mL in 1 VIAL, SINGLE-DOSE (71288-019-10)

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": "944a7489-75b7-4841-a189-1bb66fa83e30", "openfda": {"nui": ["N0000175938", "M0021223"], "unii": ["70JE2N95KR"], "rxcui": ["581531"], "spl_set_id": ["4cbefeb0-7d63-4c49-9906-384acc53dd15"], "pharm_class_cs": ["Tetracyclines [CS]"], "pharm_class_epc": ["Tetracycline-class Antibacterial [EPC]"], "manufacturer_name": ["Meitheal Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL, SINGLE-DOSE in 1 CARTON (71288-019-11)  / 5 mL in 1 VIAL, SINGLE-DOSE (71288-019-10)", "package_ndc": "71288-019-11", "marketing_start_date": "20210513"}], "brand_name": "Tigecycline", "product_id": "71288-019_944a7489-75b7-4841-a189-1bb66fa83e30", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Tetracycline-class Antibacterial [EPC]", "Tetracyclines [CS]"], "product_ndc": "71288-019", "generic_name": "Tigecycline", "labeler_name": "Meitheal Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Tigecycline", "active_ingredients": [{"name": "TIGECYCLINE", "strength": "50 mg/5mL"}], "application_number": "ANDA214020", "marketing_category": "ANDA", "marketing_start_date": "20210513", "listing_expiration_date": "20261231"}