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 Identifiers#

Field, Values table
FieldValues
UniiI7L8FKN87J
Rxcui313532, 798415

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

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