NDC 64725-0104

Aplisol

Tuberculin Purified Protein Derivative

Aplisol is a Intradermal Injection in the Human Prescription Drug category. It is labeled and distributed by Tya Pharmaceuticals. The primary component is Tuberculin Purified Protein Derivative.

• Product ID: 64725-0104_c3418329-3ad4-4cdc-8662-ed38c62b64b0
• NDC: 64725-0104
• Product Type: Human Prescription Drug
• Proprietary Name: Aplisol
• Generic Name: Tuberculin Purified Protein Derivative
• Dosage Form: Injection
• Route of Administration: INTRADERMAL
• Marketing Start Date: 2014-04-25
• Marketing Category: BLA / BLA
• Application Number: BLA103782
• Labeler Name: TYA Pharmaceuticals
• Substance Name: TUBERCULIN PURIFIED PROTEIN DERIVATIVE
• Active Ingredient Strength: 5 [iU]/.1mL
• Pharm Classes: Skin Test Antigen [EPC],Tuberculosis Skin Test [EPC],Cell-mediated Immunity [PE],Antigens, Bacterial [CS]
• NDC Exclude Flag: E
• Listing Certified Through: 2017-12-31

Packaging

NDC 64725-0104-1

5 mL in 1 BOTTLE (64725-0104-1)

• Marketing Start Date: 2014-04-25
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 64725-0104-1 [64725010401]

Aplisol INJECTION

• Marketing Category: BLA
• Application Number: BLA103782
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2014-04-25
• Inactivation Date: 2020-01-31

Drug Details

Active Ingredients

Ingredient	Strength
TUBERCULIN PURIFIED PROTEIN DERIVATIVE	5 [iU]/.1mL

OpenFDA Data

• SPL SET ID: 33ad349a-2969-4591-8c67-4d2a422a5ffb
• Manufacturer:
  • TYA Pharmaceuticals
• UNII:
  • I7L8FKN87J
• RxNorm Concept Unique ID - RxCUI:
  • 313532
  • 798408

Pharmacological Class

• Skin Test Antigen [EPC]
• Tuberculosis Skin Test [EPC]
• Cell-mediated Immunity [PE]
• Antigens
• Bacterial [CS]

NDC Crossover Matching brand name "Aplisol" or generic name "Tuberculin Purified Protein Derivative"

NDC	Brand Name	Generic Name
42023-104	Aplisol	Tuberculin Purified Protein Derivative
50090-1336	Aplisol	Tuberculin Purified Protein Derivative
64725-0104	Aplisol	Tuberculin Purified Protein Derivative
0220-7935	Tuberculinum	TUBERCULIN PURIFIED PROTEIN DERIVATIVE
0220-7944	Tuberculinum	TUBERCULIN PURIFIED PROTEIN DERIVATIVE
0220-7945	Tuberculinum	TUBERCULIN PURIFIED PROTEIN DERIVATIVE
0220-7946	Tuberculinum	TUBERCULIN PURIFIED PROTEIN DERIVATIVE
0220-7947	Tuberculinum	TUBERCULIN PURIFIED PROTEIN DERIVATIVE
0220-7948	Tuberculinum	TUBERCULIN PURIFIED PROTEIN DERIVATIVE
0220-7949	Tuberculinum	TUBERCULIN PURIFIED PROTEIN DERIVATIVE
64117-409	TUBERCULINUM	TUBERCULIN PURIFIED PROTEIN DERIVATIVE
49281-752	TUBERSOL	Tuberculin Purified Protein Derivative
50090-0261	TUBERSOL	Tuberculin Purified Protein Derivative
50090-1668	TUBERSOL	Tuberculin Purified Protein Derivative