tigecycline

Generic: tigecycline

Labeler: amneal pharmaceuticals llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name tigecycline
Generic Name tigecycline
Labeler amneal pharmaceuticals llc
Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
INTRAVENOUS
Active Ingredients

tigecycline 50 mg/5mL

Manufacturer
Amneal Pharmaceuticals LLC

Identifiers & Regulatory

Product NDC 70121-1647
Product ID 70121-1647_c21de58f-dcd0-46f7-a6d9-0ff5ba5863a1
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA211158
Listing Expiration 2026-12-31
Marketing Start 2018-01-31

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 701211647
Hyphenated Format 70121-1647

Supplemental Identifiers

RxCUI
581531
UPC
0370121164777 0370121164715
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 NDA211158 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 50 mg/5mL
source: ndc
Packaging
  • 10 VIAL in 1 CARTON (70121-1647-7) / 5 mL in 1 VIAL (70121-1647-1)
source: ndc

Packages (1)

70121-1647-7 10 VIAL in 1 CARTON (70121-1647-7) / 5 mL in 1 VIAL (70121-1647-1)

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": "c21de58f-dcd0-46f7-a6d9-0ff5ba5863a1", "openfda": {"nui": ["N0000175938", "M0021223"], "upc": ["0370121164777", "0370121164715"], "unii": ["70JE2N95KR"], "rxcui": ["581531"], "spl_set_id": ["8450bd15-2b06-4fc7-b302-9021312e3f0d"], "pharm_class_cs": ["Tetracyclines [CS]"], "pharm_class_epc": ["Tetracycline-class Antibacterial [EPC]"], "manufacturer_name": ["Amneal Pharmaceuticals LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL in 1 CARTON (70121-1647-7)  / 5 mL in 1 VIAL (70121-1647-1)", "package_ndc": "70121-1647-7", "marketing_start_date": "20180131"}], "brand_name": "Tigecycline", "product_id": "70121-1647_c21de58f-dcd0-46f7-a6d9-0ff5ba5863a1", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Tetracycline-class Antibacterial [EPC]", "Tetracyclines [CS]"], "product_ndc": "70121-1647", "generic_name": "Tigecycline", "labeler_name": "Amneal Pharmaceuticals LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Tigecycline", "active_ingredients": [{"name": "TIGECYCLINE", "strength": "50 mg/5mL"}], "application_number": "NDA211158", "marketing_category": "NDA", "marketing_start_date": "20180131", "listing_expiration_date": "20261231"}