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 ID64725-0104_c3418329-3ad4-4cdc-8662-ed38c62b64b0
NDC64725-0104
Product TypeHuman Prescription Drug
Proprietary NameAplisol
Generic NameTuberculin Purified Protein Derivative
Dosage FormInjection
Route of AdministrationINTRADERMAL
Marketing Start Date2014-04-25
Marketing CategoryBLA / BLA
Application NumberBLA103782
Labeler NameTYA Pharmaceuticals
Substance NameTUBERCULIN PURIFIED PROTEIN DERIVATIVE
Active Ingredient Strength5 [iU]/.1mL
Pharm ClassesSkin Test Antigen [EPC],Tuberculosis Skin Test [EPC],Cell-mediated Immunity [PE],Antigens, Bacterial [CS]
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 64725-0104-1

5 mL in 1 BOTTLE (64725-0104-1)
Marketing Start Date2014-04-25
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 64725-0104-1 [64725010401]

Aplisol INJECTION
Marketing CategoryBLA
Application NumberBLA103782
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2014-04-25
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
TUBERCULIN PURIFIED PROTEIN DERIVATIVE5 [iU]/.1mL

OpenFDA Data

SPL SET ID:33ad349a-2969-4591-8c67-4d2a422a5ffb
Manufacturer
UNII
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"

    NDCBrand NameGeneric Name
    42023-104AplisolTuberculin Purified Protein Derivative
    50090-1336AplisolTuberculin Purified Protein Derivative
    64725-0104AplisolTuberculin Purified Protein Derivative
    0220-7935TuberculinumTUBERCULIN PURIFIED PROTEIN DERIVATIVE
    0220-7944TuberculinumTUBERCULIN PURIFIED PROTEIN DERIVATIVE
    0220-7945TuberculinumTUBERCULIN PURIFIED PROTEIN DERIVATIVE
    0220-7946TuberculinumTUBERCULIN PURIFIED PROTEIN DERIVATIVE
    0220-7947TuberculinumTUBERCULIN PURIFIED PROTEIN DERIVATIVE
    0220-7948TuberculinumTUBERCULIN PURIFIED PROTEIN DERIVATIVE
    0220-7949TuberculinumTUBERCULIN PURIFIED PROTEIN DERIVATIVE
    64117-409TUBERCULINUMTUBERCULIN PURIFIED PROTEIN DERIVATIVE
    49281-752TUBERSOLTuberculin Purified Protein Derivative
    50090-0261TUBERSOLTuberculin Purified Protein Derivative
    50090-1668TUBERSOLTuberculin Purified Protein Derivative

    Trademark Results [Aplisol]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    APLISOL
    APLISOL
    72379567 0925391 Live/Registered
    PARKE, DAVIS & COMPANY
    1970-12-28

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