FDA.reportPublic FDA data

Aplisol

Product NDC
64725-0104
11-digit product format
647250104
Labeler code
64725
Product ID
64725-0104_c3418329-3ad4-4cdc-8662-ed38c62b64b0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tuberculin Purified Protein Derivative
Dosage form
INJECTION
Route
INTRADERMAL
Labeler
TYA Pharmaceuticals
Application
BLA103782
Marketing category
BLA
Marketing start
2014-04-25
Marketing end
0000-00-00
Substance
TUBERCULIN PURIFIED PROTEIN DERIVATIVE
Active strength
5 [iU]/.1mL
Pharmacologic classes
Skin Test Antigen [EPC],Tuberculosis Skin Test [EPC],Cell-mediated Immunity [PE],Antigens, Bacterial [CS]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct64725-0104IInactivated by FDA2026-07-31
excluded packagepackage64725-010464725-0104-1IInactivated by FDA2026-07-31

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
APLISOLTUBERCULIN PURIFIED PROTEIN DERIVATIVEA-S Medication Solutions9f025046-850f-46c1-bdfd-2450321443072023-05-09Warnings, Adverse reactionsExact identifier
application number: BLA103782

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
64725-0104-12020-01-31C16284748780-19d75b9cf-e975-f424-e053-dadaa90a57ceAPLISOL (Tuberculin Purified Protein Derivative, Diluted [Stabilized Solution]) ®

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64725-0104-1Aplisol5 mL in 1 BOTTLEINJECTION53

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64725-0104APLISOL (TUBERCULIN PURIFIED PROTEIN DERIVATIVE) INJECTION [TYA PHARMACEUTICALS]3Legacy NDC, 1 package rows20160618_33ad349a-2969-4591-8c67-4d2a422a5ffb.zip

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
103782AplisolTuberculin, Purified Protein Derivative351(a)Rx2026-06-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
798408Aplisol 5 UNT in 0.1 ML Injectable SolutionPSN33ad349a-2969-4591-8c67-4d2a422a5ffb3
313532purified protein derivative of tuberculin 5 UNT in 0.1 ML Injectable SolutionPSN33ad349a-2969-4591-8c67-4d2a422a5ffb3
798408purified protein derivative of tuberculin 50 UNT/ML Injectable Solution [Aplisol]SBD33ad349a-2969-4591-8c67-4d2a422a5ffb3
313532purified protein derivative of tuberculin 50 UNT/ML Injectable SolutionSCD33ad349a-2969-4591-8c67-4d2a422a5ffb3
798408Aplisol 5 UNT per 0.1 ML Injectable SolutionSY33ad349a-2969-4591-8c67-4d2a422a5ffb3
798408Aplisol 50 UNT/ML Injectable SolutionSY33ad349a-2969-4591-8c67-4d2a422a5ffb3
313532purified protein derivative of tuberculin 5 UNT per 0.1 ML Injectable SolutionSY33ad349a-2969-4591-8c67-4d2a422a5ffb3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
64725-0104-1647250104015 mL in 1 BOTTLE5 mlHistorical