NDC 0008-4994

Tygacil

Tigecycline

Tygacil is a Intravenous Injection, Powder, Lyophilized, For Solution in the Human Prescription Drug category. It is labeled and distributed by Wyeth Pharmaceuticals Llc, A Subsidiary Of Pfizer Inc.. The primary component is Tigecycline.

• Product ID: 0008-4994_0c462e46-a947-431b-98a8-4f3b8050d2ef
• NDC: 0008-4994
• Product Type: Human Prescription Drug
• Proprietary Name: Tygacil
• Generic Name: Tigecycline
• Dosage Form: Injection, Powder, Lyophilized, For Solution
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2017-02-08
• Marketing Category: NDA / NDA
• Application Number: NDA021821
• Labeler Name: Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.
• Substance Name: TIGECYCLINE
• Active Ingredient Strength: 50 mg/5mL
• Pharm Classes: Tetracycline-class Antibacterial [EPC],Tetracyclines [CS]
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 0008-4994-20

10 VIAL, SINGLE-USE in 1 CARTON (0008-4994-20) > 50 mL in 1 VIAL, SINGLE-USE (0008-4994-19)

• Marketing Start Date: 2017-02-08
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0008-4994-19 [00008499419]

Tygacil INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

• Marketing Category: NDA
• Application Number: NDA021821
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2017-02-08

NDC 0008-4994-01 [00008499401]

Tygacil INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

• Marketing Category: NDA
• Application Number: NDA021821
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2017-02-08

NDC 0008-4994-20 [00008499420]

Tygacil INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

• Marketing Category: NDA
• Application Number: NDA021821
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2017-02-08

NDC 0008-4994-02 [00008499402]

Tygacil INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

• Marketing Category: NDA
• Application Number: NDA021821
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2017-02-08

Drug Details

Active Ingredients

Ingredient	Strength
TIGECYCLINE	50 mg/5mL

OpenFDA Data

• SPL SET ID: fd826e47-1b77-4ffd-bb22-fda3379903b0
• Manufacturer:
  • Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.
• UNII:
  • 70JE2N95KR
• RxNorm Concept Unique ID - RxCUI:
  • 584201
  • 581531

Pharmacological Class

• Tetracycline-class Antibacterial [EPC]
• Tetracyclines [CS]

NDC Crossover Matching brand name "Tygacil" or generic name "Tigecycline"

NDC	Brand Name	Generic Name
0008-4990	Tygacil	TIGECYCLINE
0008-4994	Tygacil	TIGECYCLINE
0781-3481	Tigecycline	Tigecycline
16729-364	TIGECYCLINE	TIGECYCLINE
55150-228	Tigecycline	Tigecycline
60505-6098	Tigecycline	TIGECYCLINE
63323-960	Tigecycline	Tigecycline
70121-1647	Tigecycline	Tigecycline
70594-035	Tigecycline	Tigecycline
71288-019	Tigecycline	Tigecycline