FDA.reportPublic FDA data

TUBERSOL

Product NDC
50090-1668
11-digit product format
500901668
Labeler code
50090
Product ID
50090-1668_5471ed3d-e3c2-407e-b467-cc5a1c8be2fa
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

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 · 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
ndc (product): 50090-1668
TUBERSOLTUBERCULIN PURIFIED PROTEIN DERIVATIVEA-S Medication Solutions261efc52-a105-4c2c-a8ce-9eee20b62efc2023-06-15Warnings, Adverse reactionsExact identifier
application number: BLA103941

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
ca1199eb-2f86-4e27-967b-fb1c814dafd2Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-1668-0TUBERSOL1 in 1 CARTONINJECTION, SOLUTION112
50090-1668-0TUBERSOL5 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION512

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-1668-0ML - Milliliter50090-166836314e10-f162-4ae7-8721-ad00ec03f04312018-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-1668TUBERSOL (TUBERCULIN PURIFIED PROTEIN DERIVATIVE) INJECTION, SOLUTION [A-S MEDICATION SOLUTIONS]12Current NDC, Legacy NDC, 2 package rows20230816_ca1199eb-2f86-4e27-967b-fb1c814dafd2.zip

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
103941TubersolTuberculin, Purified Protein Derivative351(a)Rx2026-06-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313532purified protein derivative of tuberculin 5 UNT in 0.1 ML Injectable SolutionPSNca1199eb-2f86-4e27-967b-fb1c814dafd212
798415TUBERSOL 5 UNT in 0.1 ML Injectable SolutionPSNca1199eb-2f86-4e27-967b-fb1c814dafd212
798415purified protein derivative of tuberculin 50 UNT/ML Injectable Solution [Tubersol]SBDca1199eb-2f86-4e27-967b-fb1c814dafd212
313532purified protein derivative of tuberculin 50 UNT/ML Injectable SolutionSCDca1199eb-2f86-4e27-967b-fb1c814dafd212
313532purified protein derivative of tuberculin 5 UNT per 0.1 ML Injectable SolutionSYca1199eb-2f86-4e27-967b-fb1c814dafd212
798415Tubersol 5 UNT per 0.1 ML Injectable SolutionSYca1199eb-2f86-4e27-967b-fb1c814dafd212
798415Tubersol 50 UNT/ML Injectable SolutionSYca1199eb-2f86-4e27-967b-fb1c814dafd212

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-1668-0500901668001 VIAL, MULTI-DOSE in 1 CARTON (50090-1668-0) / 5 mL in 1 VIAL, MULTI-DOSE2015-01-280000-00-00NoNoCurrent