tygacil

Generic: tigecycline

Labeler: wyeth pharmaceuticals llc, a subsidiary of pfizer inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name tygacil
Generic Name tigecycline
Labeler wyeth pharmaceuticals llc, a subsidiary of pfizer inc.
Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
INTRAVENOUS
Active Ingredients

tigecycline 50 mg/5mL

Manufacturer
Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.

Identifiers & Regulatory

Product NDC 0008-4994
Product ID 0008-4994_632c318a-2046-484c-9b5d-af354cbca86a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA021821
Listing Expiration 2026-12-31
Marketing Start 2017-02-08

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 00084994
Hyphenated Format 0008-4994

Supplemental Identifiers

RxCUI
581531 584201
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 tygacil (source: ndc)
Generic Name tigecycline (source: ndc)
Application Number NDA021821 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 50 mg/5mL
source: ndc
Packaging
  • 10 VIAL, SINGLE-DOSE in 1 CARTON (0008-4994-20) / 5 mL in 1 VIAL, SINGLE-DOSE (0008-4994-19)
source: ndc

Packages (1)

0008-4994-20 10 VIAL, SINGLE-DOSE in 1 CARTON (0008-4994-20) / 5 mL in 1 VIAL, SINGLE-DOSE (0008-4994-19)

Ingredients (1)

tigecycline (50 mg/5mL)

Linked Drug Pages (1)

Tygacil ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "632c318a-2046-484c-9b5d-af354cbca86a", "openfda": {"nui": ["N0000175938", "M0021223"], "unii": ["70JE2N95KR"], "rxcui": ["581531", "584201"], "spl_set_id": ["fd826e47-1b77-4ffd-bb22-fda3379903b0"], "pharm_class_cs": ["Tetracyclines [CS]"], "pharm_class_epc": ["Tetracycline-class Antibacterial [EPC]"], "manufacturer_name": ["Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL, SINGLE-DOSE in 1 CARTON (0008-4994-20)  / 5 mL in 1 VIAL, SINGLE-DOSE (0008-4994-19)", "package_ndc": "0008-4994-20", "marketing_start_date": "20170208"}], "brand_name": "Tygacil", "product_id": "0008-4994_632c318a-2046-484c-9b5d-af354cbca86a", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Tetracycline-class Antibacterial [EPC]", "Tetracyclines [CS]"], "product_ndc": "0008-4994", "generic_name": "TIGECYCLINE", "labeler_name": "Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Tygacil", "active_ingredients": [{"name": "TIGECYCLINE", "strength": "50 mg/5mL"}], "application_number": "NDA021821", "marketing_category": "NDA", "marketing_start_date": "20170208", "listing_expiration_date": "20261231"}