Aplisol

Product NDC: 42023-104
11-digit product format: 420230104
Labeler code: 42023
Product ID: 42023-104_a97e057f-6554-4ce2-bc75-3ebc1978e0d0
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Tuberculin Purified Protein Derivative
Dosage form: INJECTION
Route: INTRADERMAL
Labeler: ENDO USA, Inc.
Application: BLA103782
Marketing category: BLA
Marketing start: 2008-04-25
Substance: TUBERCULIN PURIFIED PROTEIN DERIVATIVE
Active strength: 5 [iU]/.1mL
Pharmacologic classes: Antigens, Bacterial [CS], Cell-mediated Immunity [PE], Skin Test Antigen [EPC], Tuberculosis Skin Test [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	42023-104		I	Inactivated by FDA	2026-08-17
excluded package	package	42023-104	42023-104-01	I	Inactivated by FDA	2026-08-17
excluded package	package	42023-104	42023-104-05	I	Inactivated by FDA	2026-08-17

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
42023-104-01	Aplisol	1 in 1 CARTON	INJECTION	1	11
42023-104-01	Aplisol	1 mL in 1 VIAL	INJECTION	1	11
42023-104-05	Aplisol	1 in 1 CARTON	INJECTION	1	11
42023-104-05	Aplisol	5 mL in 1 VIAL	INJECTION	5	11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
42023-104-01	ML - Milliliter	42023-104	3b808024-0d83-4833-962c-dcdfc205d872	1	2012-07-24
42023-104-05	ML - Milliliter	42023-104	0924da6d-5239-4597-b77f-981c8958f79e	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Tuberculin Purified Protein Derivative	ACTIVE INGREDIENT	I7L8FKN87J	APLISOL (TUBERCULIN PURIFIED PROTEIN DERIVATIVE) INJECTION [PAR PHARMACEUTICAL, INC.]	6
tuberculin Purified Protein Derivative	ACTIVE MOIETY	I7L8FKN87J	APLISOL (TUBERCULIN PURIFIED PROTEIN DERIVATIVE) INJECTION [PAR PHARMACEUTICAL, INC.]	6
Phenol	INACTIVE INGREDIENT	339NCG44TV	APLISOL (TUBERCULIN PURIFIED PROTEIN DERIVATIVE) INJECTION [PAR PHARMACEUTICAL, INC.]	6
Polysorbate 80	INACTIVE INGREDIENT	6OZP39ZG8H	APLISOL (TUBERCULIN PURIFIED PROTEIN DERIVATIVE) INJECTION [PAR PHARMACEUTICAL, INC.]	6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
42023-104	APLISOL (TUBERCULIN PURIFIED PROTEIN DERIVATIVE) INJECTION [ENDO USA, INC.]	11	Current NDC, Legacy NDC, 4 package rows	20240821_1e91a67c-1694-4523-9548-58f7a8871134.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
APLISOL	TUBERCULIN PURIFIED PROTEIN DERIVATIVE	A-S Medication Solutions	9f025046-850f-46c1-bdfd-245032144307	2023-05-09	Warnings, Adverse reactions	Exact identifier application number: BLA103782

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLA	Proprietary name	Proper name	License type	Status	Latest source
103782	Aplisol	Tuberculin, Purified Protein Derivative	351(a)	Rx	2026-08-01

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
I7L8FKN87J	TUBERCULIN PURIFIED PROTEIN DERIVATIVE	92129-86-7	TUBERCULIN PURIFIED PROTEIN DERIVATIVE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
798408	Aplisol 5 UNT in 0.1 ML Injectable Solution	PSN	9f025046-850f-46c1-bdfd-245032144307	16
313532	purified protein derivative of tuberculin 5 UNT in 0.1 ML Injectable Solution	PSN	9f025046-850f-46c1-bdfd-245032144307	16
798408	purified protein derivative of tuberculin 50 UNT/ML Injectable Solution [Aplisol]	SBD	9f025046-850f-46c1-bdfd-245032144307	16
313532	purified protein derivative of tuberculin 50 UNT/ML Injectable Solution	SCD	9f025046-850f-46c1-bdfd-245032144307	16
798408	Aplisol 5 UNT per 0.1 ML Injectable Solution	SY	9f025046-850f-46c1-bdfd-245032144307	16
798408	Aplisol 50 UNT/ML Injectable Solution	SY	9f025046-850f-46c1-bdfd-245032144307	16
313532	purified protein derivative of tuberculin 5 UNT per 0.1 ML Injectable Solution	SY	9f025046-850f-46c1-bdfd-245032144307	16
798408	Aplisol 5 UNT in 0.1 ML Injectable Solution	PSN	1e91a67c-1694-4523-9548-58f7a8871134	11
313532	purified protein derivative of tuberculin 5 UNT in 0.1 ML Injectable Solution	PSN	1e91a67c-1694-4523-9548-58f7a8871134	11
798408	purified protein derivative of tuberculin 50 UNT/ML Injectable Solution [Aplisol]	SBD	1e91a67c-1694-4523-9548-58f7a8871134	11
313532	purified protein derivative of tuberculin 50 UNT/ML Injectable Solution	SCD	1e91a67c-1694-4523-9548-58f7a8871134	11
798408	Aplisol 5 UNT per 0.1 ML Injectable Solution	SY	1e91a67c-1694-4523-9548-58f7a8871134	11
798408	Aplisol 50 UNT/ML Injectable Solution	SY	1e91a67c-1694-4523-9548-58f7a8871134	11
313532	purified protein derivative of tuberculin 5 UNT per 0.1 ML Injectable Solution	SY	1e91a67c-1694-4523-9548-58f7a8871134	11
798408	Aplisol 5 UNT in 0.1 ML Injectable Solution	PSN	33ad349a-2969-4591-8c67-4d2a422a5ffb	3
313532	purified protein derivative of tuberculin 5 UNT in 0.1 ML Injectable Solution	PSN	33ad349a-2969-4591-8c67-4d2a422a5ffb	3
798408	purified protein derivative of tuberculin 50 UNT/ML Injectable Solution [Aplisol]	SBD	33ad349a-2969-4591-8c67-4d2a422a5ffb	3
313532	purified protein derivative of tuberculin 50 UNT/ML Injectable Solution	SCD	33ad349a-2969-4591-8c67-4d2a422a5ffb	3
798408	Aplisol 5 UNT per 0.1 ML Injectable Solution	SY	33ad349a-2969-4591-8c67-4d2a422a5ffb	3
798408	Aplisol 50 UNT/ML Injectable Solution	SY	33ad349a-2969-4591-8c67-4d2a422a5ffb	3
313532	purified protein derivative of tuberculin 5 UNT per 0.1 ML Injectable Solution	SY	33ad349a-2969-4591-8c67-4d2a422a5ffb	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
42023-104-01	42023010401	1 VIAL in 1 CARTON (42023-104-01) / 1 mL in 1 VIAL	1 vial	2008-04-25	0000-00-00	No	No	Current
42023-104-05	42023010405	1 VIAL in 1 CARTON (42023-104-05) / 5 mL in 1 VIAL	1 vial	2008-04-25	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
APLISOL ® (Tuberculin Purified Protein Derivative, Diluted [Stabilized Solution])	ENDO USA, Inc.	2024-08-20	HUMAN PRESCRIPTION DRUG LABEL	11
APLISOL	A-S Medication Solutions	2023-05-09	HUMAN PRESCRIPTION DRUG LABEL	16
APLISOL (Tuberculin Purified Protein Derivative, Diluted [Stabilized Solution]) ®	TYA Pharmaceuticals	2015-07-09	HUMAN PRESCRIPTION DRUG LABEL	3