TUBERSOL

Product NDC: 49281-752
11-digit product format: 492810752
Labeler code: 49281
Product ID: 49281-752_3b4077df-355d-43d9-a762-c74656709f20
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Tuberculin Purified Protein Derivative
Dosage form: INJECTION, SOLUTION
Route: INTRADERMAL
Labeler: Sanofi Vaccines US Inc.
Application: BLA103941
Marketing category: BLA
Marketing start: 1956-08-15
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: 2027-12-31
Current FDA listing: Yes

Additional Listing Data#

Finished product: Yes
Brand name base: TUBERSOL
Listing expiration: 2027-12-31

Active Ingredients#

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

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
I7L8FKN87J	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
313532	Internal RxNorm lookup
798415	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
a4a732e9-b8ee-4e6d-8b9a-6a9d2c36bfcd	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
49281-752-21	TUBERSOL	1 in 1 CARTON	INJECTION, SOLUTION	1	18
49281-752-22	TUBERSOL	1 in 1 CARTON	INJECTION, SOLUTION	1	18
49281-752-78	TUBERSOL	1 mL in 1 VIAL, MULTI-DOSE	INJECTION, SOLUTION	1	18
49281-752-98	TUBERSOL	5 mL in 1 VIAL, MULTI-DOSE	INJECTION, SOLUTION	5	18

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
49281-752-21	ML - Milliliter	49281-752	fcaf285b-9d80-496f-a1d3-07b4fc0d58c3	1	2013-04-01
49281-752-22	ML - Milliliter	49281-752	db60372c-d5d6-47b4-91ec-debb2290cd1f	1	2013-04-01
49281-752-78	ML - Milliliter	49281-752	fcfefcdd-1456-466a-87bb-4b87b0c5d31d	1	2014-05-02
49281-752-98	ML - Milliliter	49281-752	2c4c089e-0905-46d1-8067-b1a13ace3901	1	2014-05-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Tuberculin Purified Protein Derivative	ACTIVE INGREDIENT	I7L8FKN87J	TUBERSOL (TUBERCULIN PURIFIED PROTEIN DERIVATIVE) INJECTION, SOLUTION [SANOFI PASTEUR INC.]	3
Tuberculin Purified Protein Derivative	ACTIVE MOIETY	I7L8FKN87J	TUBERSOL (TUBERCULIN PURIFIED PROTEIN DERIVATIVE) INJECTION, SOLUTION [SANOFI PASTEUR INC.]	3
Phenol	INACTIVE INGREDIENT	339NCG44TV	TUBERSOL (TUBERCULIN PURIFIED PROTEIN DERIVATIVE) INJECTION, SOLUTION [SANOFI PASTEUR INC.]	3
Polysorbate 80	INACTIVE INGREDIENT	6OZP39ZG8H	TUBERSOL (TUBERCULIN PURIFIED PROTEIN DERIVATIVE) INJECTION, SOLUTION [SANOFI PASTEUR INC.]	3
Tuberculin Purified Protein Derivative	ACTIVE INGREDIENT	I7L8FKN87J	TUBERSOL (TUBERCULIN PURIFIED PROTEIN DERIVATIVE) INJECTION, SOLUTION [PHYSICIANS TOTAL CARE, INC.]	1
Tuberculin Purified Protein Derivative	ACTIVE MOIETY	I7L8FKN87J	TUBERSOL (TUBERCULIN PURIFIED PROTEIN DERIVATIVE) INJECTION, SOLUTION [PHYSICIANS TOTAL CARE, INC.]	1
Phenol	INACTIVE INGREDIENT	339NCG44TV	TUBERSOL (TUBERCULIN PURIFIED PROTEIN DERIVATIVE) INJECTION, SOLUTION [PHYSICIANS TOTAL CARE, INC.]	1
Polysorbate 80	INACTIVE INGREDIENT	6OZP39ZG8H	TUBERSOL (TUBERCULIN PURIFIED PROTEIN DERIVATIVE) INJECTION, SOLUTION [PHYSICIANS TOTAL CARE, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
49281-752	TUBERSOL (TUBERCULIN PURIFIED PROTEIN DERIVATIVE) INJECTION, SOLUTION [SANOFI PASTEUR INC.]	16	Current NDC, Legacy NDC, 4 package rows	20240130_a4a732e9-b8ee-4e6d-8b9a-6a9d2c36bfcd.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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
TUBERSOL	TUBERCULIN PURIFIED PROTEIN DERIVATIVE	Sanofi Vaccines US Inc.	a4a732e9-b8ee-4e6d-8b9a-6a9d2c36bfcd	2026-05-01	Warnings, Adverse reactions	Exact identifier application number: BLA103941 ndc (product): 49281-752
TUBERSOL	TUBERCULIN PURIFIED PROTEIN DERIVATIVE	A-S Medication Solutions	ca1199eb-2f86-4e27-967b-fb1c814dafd2	2023-08-14	Warnings, Adverse reactions	Exact identifier application number: BLA103941
TUBERSOL	TUBERCULIN PURIFIED PROTEIN DERIVATIVE	A-S Medication Solutions	261efc52-a105-4c2c-a8ce-9eee20b62efc	2023-06-15	Warnings, Adverse reactions	Exact identifier application number: BLA103941

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLA	Proprietary name	Proper name	License type	Status	Latest source
103941	Tubersol	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
313532	purified protein derivative of tuberculin 5 UNT in 0.1 ML Injectable Solution	PSN	261efc52-a105-4c2c-a8ce-9eee20b62efc	21
798415	TUBERSOL 5 UNT in 0.1 ML Injectable Solution	PSN	261efc52-a105-4c2c-a8ce-9eee20b62efc	21
798415	purified protein derivative of tuberculin 50 UNT/ML Injectable Solution [Tubersol]	SBD	261efc52-a105-4c2c-a8ce-9eee20b62efc	21
313532	purified protein derivative of tuberculin 50 UNT/ML Injectable Solution	SCD	261efc52-a105-4c2c-a8ce-9eee20b62efc	21
313532	purified protein derivative of tuberculin 5 UNT per 0.1 ML Injectable Solution	SY	261efc52-a105-4c2c-a8ce-9eee20b62efc	21
798415	Tubersol 5 UNT per 0.1 ML Injectable Solution	SY	261efc52-a105-4c2c-a8ce-9eee20b62efc	21
798415	Tubersol 50 UNT/ML Injectable Solution	SY	261efc52-a105-4c2c-a8ce-9eee20b62efc	21
313532	purified protein derivative of tuberculin 5 UNT in 0.1 ML Injectable Solution	PSN	a4a732e9-b8ee-4e6d-8b9a-6a9d2c36bfcd	18
798415	TUBERSOL 5 UNT in 0.1 ML Injectable Solution	PSN	a4a732e9-b8ee-4e6d-8b9a-6a9d2c36bfcd	18
798415	purified protein derivative of tuberculin 50 UNT/ML Injectable Solution [Tubersol]	SBD	a4a732e9-b8ee-4e6d-8b9a-6a9d2c36bfcd	18
313532	purified protein derivative of tuberculin 50 UNT/ML Injectable Solution	SCD	a4a732e9-b8ee-4e6d-8b9a-6a9d2c36bfcd	18
313532	purified protein derivative of tuberculin 5 UNT per 0.1 ML Injectable Solution	SY	a4a732e9-b8ee-4e6d-8b9a-6a9d2c36bfcd	18
798415	Tubersol 5 UNT per 0.1 ML Injectable Solution	SY	a4a732e9-b8ee-4e6d-8b9a-6a9d2c36bfcd	18
798415	Tubersol 50 UNT/ML Injectable Solution	SY	a4a732e9-b8ee-4e6d-8b9a-6a9d2c36bfcd	18
313532	purified protein derivative of tuberculin 5 UNT in 0.1 ML Injectable Solution	PSN	ca1199eb-2f86-4e27-967b-fb1c814dafd2	12
798415	TUBERSOL 5 UNT in 0.1 ML Injectable Solution	PSN	ca1199eb-2f86-4e27-967b-fb1c814dafd2	12
798415	purified protein derivative of tuberculin 50 UNT/ML Injectable Solution [Tubersol]	SBD	ca1199eb-2f86-4e27-967b-fb1c814dafd2	12
313532	purified protein derivative of tuberculin 50 UNT/ML Injectable Solution	SCD	ca1199eb-2f86-4e27-967b-fb1c814dafd2	12
313532	purified protein derivative of tuberculin 5 UNT per 0.1 ML Injectable Solution	SY	ca1199eb-2f86-4e27-967b-fb1c814dafd2	12
798415	Tubersol 5 UNT per 0.1 ML Injectable Solution	SY	ca1199eb-2f86-4e27-967b-fb1c814dafd2	12
798415	Tubersol 50 UNT/ML Injectable Solution	SY	ca1199eb-2f86-4e27-967b-fb1c814dafd2	12
313532	purified protein derivative of tuberculin 5 UNT in 0.1 ML Injectable Solution	PSN	96d91ba3-9dfe-4420-a835-57647ea30b40	1
798415	TUBERSOL 5 UNT in 0.1 ML Injectable Solution	PSN	96d91ba3-9dfe-4420-a835-57647ea30b40	1
798415	purified protein derivative of tuberculin 50 UNT/ML Injectable Solution [Tubersol]	SBD	96d91ba3-9dfe-4420-a835-57647ea30b40	1
313532	purified protein derivative of tuberculin 50 UNT/ML Injectable Solution	SCD	96d91ba3-9dfe-4420-a835-57647ea30b40	1
313532	purified protein derivative of tuberculin 5 UNT per 0.1 ML Injectable Solution	SY	96d91ba3-9dfe-4420-a835-57647ea30b40	1
798415	Tubersol 5 UNT per 0.1 ML Injectable Solution	SY	96d91ba3-9dfe-4420-a835-57647ea30b40	1
798415	Tubersol 50 UNT/ML Injectable Solution	SY	96d91ba3-9dfe-4420-a835-57647ea30b40	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
49281-752-21	49281075221	1 VIAL, MULTI-DOSE in 1 CARTON (49281-752-21) / 1 mL in 1 VIAL, MULTI-DOSE (49281-752-78)		1956-08-15	0000-00-00	No	No	Current
49281-752-22	49281075222	1 VIAL, MULTI-DOSE in 1 CARTON (49281-752-22) / 5 mL in 1 VIAL, MULTI-DOSE (49281-752-98)		1956-08-15	0000-00-00	No	No	Current
49281-752-78	49281075278	1 mL in 1 VIAL, MULTI-DOSE	1 ml					Historical
49281-752-98	49281075298	5 mL in 1 VIAL, MULTI-DOSE	5 ml					Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Tuberculin Purified Protein Derivative (Mantoux) TUBERSOL ®	Sanofi Vaccines US Inc. \| Sanofi Vaccines Canada Ltd.	2026-05-01	HUMAN PRESCRIPTION DRUG LABEL	18
Tuberculin Purified Protein Derivative (Mantoux) TUBERSOL ®	A-S Medication Solutions	2023-08-14	HUMAN PRESCRIPTION DRUG LABEL	12
Tuberculin Purified Protein Derivative (Mantoux) TUBERSOL ®	A-S Medication Solutions	2023-06-15	HUMAN PRESCRIPTION DRUG LABEL	21
Tuberculin Purified Protein Derivative (Mantoux) TUBERSOL ®	Physicians Total Care, Inc.	2013-05-22	HUMAN PRESCRIPTION DRUG LABEL	1