FDA.reportPublic FDA data

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
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
49281-752-21TUBERSOL1 in 1 CARTONINJECTION, SOLUTION118
49281-752-22TUBERSOL1 in 1 CARTONINJECTION, SOLUTION118
49281-752-78TUBERSOL1 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION118
49281-752-98TUBERSOL5 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION518

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49281-752-21ML - Milliliter49281-752fcaf285b-9d80-496f-a1d3-07b4fc0d58c312013-04-01
49281-752-22ML - Milliliter49281-752db60372c-d5d6-47b4-91ec-debb2290cd1f12013-04-01
49281-752-78ML - Milliliter49281-752fcfefcdd-1456-466a-87bb-4b87b0c5d31d12014-05-02
49281-752-98ML - Milliliter49281-7522c4c089e-0905-46d1-8067-b1a13ace390112014-05-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Tuberculin Purified Protein DerivativeACTIVE INGREDIENTI7L8FKN87JTUBERSOL (TUBERCULIN PURIFIED PROTEIN DERIVATIVE) INJECTION, SOLUTION [SANOFI PASTEUR INC.]3
Tuberculin Purified Protein DerivativeACTIVE MOIETYI7L8FKN87JTUBERSOL (TUBERCULIN PURIFIED PROTEIN DERIVATIVE) INJECTION, SOLUTION [SANOFI PASTEUR INC.]3
PhenolINACTIVE INGREDIENT339NCG44TVTUBERSOL (TUBERCULIN PURIFIED PROTEIN DERIVATIVE) INJECTION, SOLUTION [SANOFI PASTEUR INC.]3
Polysorbate 80INACTIVE INGREDIENT6OZP39ZG8HTUBERSOL (TUBERCULIN PURIFIED PROTEIN DERIVATIVE) INJECTION, SOLUTION [SANOFI PASTEUR INC.]3
Tuberculin Purified Protein DerivativeACTIVE INGREDIENTI7L8FKN87JTUBERSOL (TUBERCULIN PURIFIED PROTEIN DERIVATIVE) INJECTION, SOLUTION [PHYSICIANS TOTAL CARE, INC.]1
Tuberculin Purified Protein DerivativeACTIVE MOIETYI7L8FKN87JTUBERSOL (TUBERCULIN PURIFIED PROTEIN DERIVATIVE) INJECTION, SOLUTION [PHYSICIANS TOTAL CARE, INC.]1
PhenolINACTIVE INGREDIENT339NCG44TVTUBERSOL (TUBERCULIN PURIFIED PROTEIN DERIVATIVE) INJECTION, SOLUTION [PHYSICIANS TOTAL CARE, INC.]1
Polysorbate 80INACTIVE INGREDIENT6OZP39ZG8HTUBERSOL (TUBERCULIN PURIFIED PROTEIN DERIVATIVE) INJECTION, SOLUTION [PHYSICIANS TOTAL CARE, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49281-752TUBERSOL (TUBERCULIN PURIFIED PROTEIN DERIVATIVE) INJECTION, SOLUTION [SANOFI PASTEUR INC.]16Current NDC, Legacy NDC, 4 package rows20240130_a4a732e9-b8ee-4e6d-8b9a-6a9d2c36bfcd.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
313532purified protein derivative of tuberculin 5 UNT in 0.1 ML Injectable SolutionPSNa4a732e9-b8ee-4e6d-8b9a-6a9d2c36bfcd18
798415TUBERSOL 5 UNT in 0.1 ML Injectable SolutionPSNa4a732e9-b8ee-4e6d-8b9a-6a9d2c36bfcd18
798415purified protein derivative of tuberculin 50 UNT/ML Injectable Solution [Tubersol]SBDa4a732e9-b8ee-4e6d-8b9a-6a9d2c36bfcd18
313532purified protein derivative of tuberculin 50 UNT/ML Injectable SolutionSCDa4a732e9-b8ee-4e6d-8b9a-6a9d2c36bfcd18
313532purified protein derivative of tuberculin 5 UNT per 0.1 ML Injectable SolutionSYa4a732e9-b8ee-4e6d-8b9a-6a9d2c36bfcd18
798415Tubersol 5 UNT per 0.1 ML Injectable SolutionSYa4a732e9-b8ee-4e6d-8b9a-6a9d2c36bfcd18
798415Tubersol 50 UNT/ML Injectable SolutionSYa4a732e9-b8ee-4e6d-8b9a-6a9d2c36bfcd18
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
313532purified protein derivative of tuberculin 5 UNT in 0.1 ML Injectable SolutionPSN96d91ba3-9dfe-4420-a835-57647ea30b401
798415TUBERSOL 5 UNT in 0.1 ML Injectable SolutionPSN96d91ba3-9dfe-4420-a835-57647ea30b401
798415purified protein derivative of tuberculin 50 UNT/ML Injectable Solution [Tubersol]SBD96d91ba3-9dfe-4420-a835-57647ea30b401
313532purified protein derivative of tuberculin 50 UNT/ML Injectable SolutionSCD96d91ba3-9dfe-4420-a835-57647ea30b401
313532purified protein derivative of tuberculin 5 UNT per 0.1 ML Injectable SolutionSY96d91ba3-9dfe-4420-a835-57647ea30b401
798415Tubersol 5 UNT per 0.1 ML Injectable SolutionSY96d91ba3-9dfe-4420-a835-57647ea30b401
798415Tubersol 50 UNT/ML Injectable SolutionSY96d91ba3-9dfe-4420-a835-57647ea30b401

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49281-752-21492810752211 VIAL, MULTI-DOSE in 1 CARTON (49281-752-21) / 1 mL in 1 VIAL, MULTI-DOSE (49281-752-78) 1956-08-150000-00-00NoNoCurrent
49281-752-22492810752221 VIAL, MULTI-DOSE in 1 CARTON (49281-752-22) / 5 mL in 1 VIAL, MULTI-DOSE (49281-752-98) 1956-08-150000-00-00NoNoCurrent
49281-752-78492810752781 mL in 1 VIAL, MULTI-DOSE1 mlHistorical
49281-752-98492810752985 mL in 1 VIAL, MULTI-DOSE5 mlHistorical