FDA.reportPublic FDA data

TUBERSOL

Product NDC
50090-0261
11-digit product format
500900261
Labeler code
50090
Product ID
50090-0261_d88c50ba-fe16-4d39-8c61-42549f200d67
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tuberculin Purified Protein Derivative
Dosage form
INJECTION, SOLUTION
Route
INTRADERMAL
Labeler
A-S Medication Solutions
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
TUBERSOL
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TUBERCULIN PURIFIED PROTEIN DERIVATIVE5 [iU]/.1mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
I7L8FKN87JInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
261efc52-a105-4c2c-a8ce-9eee20b62efcAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-0261-0TUBERSOL1 in 1 CARTONINJECTION, SOLUTION121
50090-0261-0TUBERSOL1 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION121

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-0261-0ML - Milliliter50090-0261f4e14d53-2533-447e-afdb-2bab6f0b093712018-08-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-0261TUBERSOL (TUBERCULIN PURIFIED PROTEIN DERIVATIVE) INJECTION, SOLUTION [A-S MEDICATION SOLUTIONS]21Current NDC, Legacy NDC, 2 package rows20230617_261efc52-a105-4c2c-a8ce-9eee20b62efc.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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TUBERSOLTUBERCULIN PURIFIED PROTEIN DERIVATIVESanofi Vaccines US Inc.a4a732e9-b8ee-4e6d-8b9a-6a9d2c36bfcd2026-05-01Warnings, Adverse reactionsExact identifier
application number: BLA103941
TUBERSOLTUBERCULIN PURIFIED PROTEIN DERIVATIVEA-S Medication Solutionsca1199eb-2f86-4e27-967b-fb1c814dafd22023-08-14Warnings, Adverse reactionsExact identifier
application number: BLA103941
TUBERSOLTUBERCULIN PURIFIED PROTEIN DERIVATIVEA-S Medication Solutions261efc52-a105-4c2c-a8ce-9eee20b62efc2023-06-15Warnings, Adverse reactionsExact identifier
application number: BLA103941
ndc (product): 50090-0261

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
103941TubersolTuberculin, Purified Protein Derivative351(a)Rx2026-08-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313532purified protein derivative of tuberculin 5 UNT in 0.1 ML Injectable SolutionPSN261efc52-a105-4c2c-a8ce-9eee20b62efc21
798415TUBERSOL 5 UNT in 0.1 ML Injectable SolutionPSN261efc52-a105-4c2c-a8ce-9eee20b62efc21
798415purified protein derivative of tuberculin 50 UNT/ML Injectable Solution [Tubersol]SBD261efc52-a105-4c2c-a8ce-9eee20b62efc21
313532purified protein derivative of tuberculin 50 UNT/ML Injectable SolutionSCD261efc52-a105-4c2c-a8ce-9eee20b62efc21
313532purified protein derivative of tuberculin 5 UNT per 0.1 ML Injectable SolutionSY261efc52-a105-4c2c-a8ce-9eee20b62efc21
798415Tubersol 5 UNT per 0.1 ML Injectable SolutionSY261efc52-a105-4c2c-a8ce-9eee20b62efc21
798415Tubersol 50 UNT/ML Injectable SolutionSY261efc52-a105-4c2c-a8ce-9eee20b62efc21

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-0261-0500900261001 VIAL, MULTI-DOSE in 1 CARTON (50090-0261-0) / 1 mL in 1 VIAL, MULTI-DOSE2016-06-290000-00-00NoNoCurrent