Home NDC 49281-752 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 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.
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.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength 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 Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded 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
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 2026-06-01
DailyMed RxNorm Mappings# 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