tubersol

Generic: tuberculin purified protein derivative

Labeler: sanofi pasteur inc.
NDC Directory HUMAN PRESCRIPTION DRUG BLA Inactive Finished

Drug Facts

Product Profile

Brand Name tubersol
Generic Name tuberculin purified protein derivative
Labeler sanofi pasteur inc.
Dosage Form INJECTION, SOLUTION
Routes
INTRADERMAL
Active Ingredients

tuberculin purified protein derivative 5 [iU]/.1mL

Manufacturer
Sanofi Pasteur Inc.

Identifiers & Regulatory

Product NDC 49281-752
Product ID 49281-752_82cb9457-e7b0-47d4-b315-52f39ff9a91e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA103941
Listing Expiration 2026-12-31
Marketing Start 1956-08-15

Pharmacologic Class

Established (EPC)
skin test antigen [epc] tuberculosis skin test [epc]
Chemical Structure
antigens, bacterial [cs]
Physiologic Effect
cell-mediated immunity [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 49281752
Hyphenated Format 49281-752

Supplemental Identifiers

RxCUI
313532 798415
UNII
I7L8FKN87J
NUI
N0000184316 N0000184315 N0000184306 M0001408

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name tubersol (source: ndc)
Generic Name tuberculin purified protein derivative (source: ndc)
Application Number BLA103941 (source: ndc)
Routes
INTRADERMAL
source: ndc

Resolved Composition

Strengths
  • 5 [iU]/.1mL
source: ndc
Packaging
  • 1 VIAL, MULTI-DOSE in 1 CARTON (49281-752-21) / 1 mL in 1 VIAL, MULTI-DOSE (49281-752-78)
  • 1 VIAL, MULTI-DOSE in 1 CARTON (49281-752-22) / 5 mL in 1 VIAL, MULTI-DOSE (49281-752-98)
source: ndc

Packages (2)

49281-752-21 1 VIAL, MULTI-DOSE in 1 CARTON (49281-752-21) / 1 mL in 1 VIAL, MULTI-DOSE (49281-752-78) 49281-752-22 1 VIAL, MULTI-DOSE in 1 CARTON (49281-752-22) / 5 mL in 1 VIAL, MULTI-DOSE (49281-752-98)

Ingredients (1)

tuberculin purified protein derivative (5 [iU]/.1mL)

Linked Drug Pages (1)

TUBERSOL ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRADERMAL"], "spl_id": "82cb9457-e7b0-47d4-b315-52f39ff9a91e", "openfda": {"nui": ["N0000184316", "N0000184315", "N0000184306", "M0001408"], "unii": ["I7L8FKN87J"], "rxcui": ["313532", "798415"], "spl_set_id": ["a4a732e9-b8ee-4e6d-8b9a-6a9d2c36bfcd"], "pharm_class_cs": ["Antigens, Bacterial [CS]"], "pharm_class_pe": ["Cell-mediated Immunity [PE]"], "pharm_class_epc": ["Skin Test Antigen [EPC]", "Tuberculosis Skin Test [EPC]"], "manufacturer_name": ["Sanofi Pasteur Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, MULTI-DOSE in 1 CARTON (49281-752-21)  / 1 mL in 1 VIAL, MULTI-DOSE (49281-752-78)", "package_ndc": "49281-752-21", "marketing_start_date": "19560815"}, {"sample": false, "description": "1 VIAL, MULTI-DOSE in 1 CARTON (49281-752-22)  / 5 mL in 1 VIAL, MULTI-DOSE (49281-752-98)", "package_ndc": "49281-752-22", "marketing_start_date": "19560815"}], "brand_name": "TUBERSOL", "product_id": "49281-752_82cb9457-e7b0-47d4-b315-52f39ff9a91e", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Antigens", "Bacterial [CS]", "Cell-mediated Immunity [PE]", "Skin Test Antigen [EPC]", "Tuberculosis Skin Test [EPC]"], "product_ndc": "49281-752", "generic_name": "Tuberculin Purified Protein Derivative", "labeler_name": "Sanofi Pasteur Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "TUBERSOL", "active_ingredients": [{"name": "TUBERCULIN PURIFIED PROTEIN DERIVATIVE", "strength": "5 [iU]/.1mL"}], "application_number": "BLA103941", "marketing_category": "BLA", "marketing_start_date": "19560815", "listing_expiration_date": "20261231"}