aplisol

Generic: tuberculin purified protein derivative

Labeler: endo usa, inc.
NDC Directory HUMAN PRESCRIPTION DRUG BLA Inactive Finished

Drug Facts

Product Profile

Brand Name aplisol
Generic Name tuberculin purified protein derivative
Labeler endo usa, inc.
Dosage Form INJECTION
Routes
INTRADERMAL
Active Ingredients

tuberculin purified protein derivative 5 [iU]/.1mL

Manufacturer
ENDO USA, Inc.

Identifiers & Regulatory

Product NDC 42023-104
Product ID 42023-104_a97e057f-6554-4ce2-bc75-3ebc1978e0d0
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA103782
Listing Expiration 2026-12-31
Marketing Start 2008-04-25

Pharmacologic Class

Established (EPC)
skin test antigen [epc] tuberculosis skin test [epc]
Chemical Structure
antigens, bacterial [cs]
Physiologic Effect
cell-mediated immunity [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 42023104
Hyphenated Format 42023-104

Supplemental Identifiers

RxCUI
313532 798408
UNII
I7L8FKN87J
NUI
N0000184316 N0000184315 N0000184306 M0001408

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 aplisol (source: ndc)
Generic Name tuberculin purified protein derivative (source: ndc)
Application Number BLA103782 (source: ndc)
Routes
INTRADERMAL
source: ndc

Resolved Composition

Strengths
  • 5 [iU]/.1mL
source: ndc
Packaging
  • 1 VIAL in 1 CARTON (42023-104-01) / 1 mL in 1 VIAL
  • 1 VIAL in 1 CARTON (42023-104-05) / 5 mL in 1 VIAL
source: ndc

Packages (2)

42023-104-01 1 VIAL in 1 CARTON (42023-104-01) / 1 mL in 1 VIAL 42023-104-05 1 VIAL in 1 CARTON (42023-104-05) / 5 mL in 1 VIAL

Ingredients (1)

tuberculin purified protein derivative (5 [iU]/.1mL)

Linked Drug Pages (1)

Aplisol ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRADERMAL"], "spl_id": "a97e057f-6554-4ce2-bc75-3ebc1978e0d0", "openfda": {"nui": ["N0000184316", "N0000184315", "N0000184306", "M0001408"], "unii": ["I7L8FKN87J"], "rxcui": ["313532", "798408"], "spl_set_id": ["1e91a67c-1694-4523-9548-58f7a8871134"], "pharm_class_cs": ["Antigens, Bacterial [CS]"], "pharm_class_pe": ["Cell-mediated Immunity [PE]"], "pharm_class_epc": ["Skin Test Antigen [EPC]", "Tuberculosis Skin Test [EPC]"], "manufacturer_name": ["ENDO USA, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL in 1 CARTON (42023-104-01)  / 1 mL in 1 VIAL", "package_ndc": "42023-104-01", "marketing_start_date": "20080425"}, {"sample": false, "description": "1 VIAL in 1 CARTON (42023-104-05)  / 5 mL in 1 VIAL", "package_ndc": "42023-104-05", "marketing_start_date": "20080425"}], "brand_name": "Aplisol", "product_id": "42023-104_a97e057f-6554-4ce2-bc75-3ebc1978e0d0", "dosage_form": "INJECTION", "pharm_class": ["Antigens", "Bacterial [CS]", "Cell-mediated Immunity [PE]", "Skin Test Antigen [EPC]", "Tuberculosis Skin Test [EPC]"], "product_ndc": "42023-104", "generic_name": "Tuberculin Purified Protein Derivative", "labeler_name": "ENDO USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Aplisol", "active_ingredients": [{"name": "TUBERCULIN PURIFIED PROTEIN DERIVATIVE", "strength": "5 [iU]/.1mL"}], "application_number": "BLA103782", "marketing_category": "BLA", "marketing_start_date": "20080425", "listing_expiration_date": "20261231"}