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#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

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	2026-07-31
excluded package	package	42023-104	42023-104-01	I	Inactivated by FDA	2026-07-31
excluded package	package	42023-104	42023-104-05	I	Inactivated by FDA	2026-07-31

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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

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

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	2026-06-01

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