FDA.reportPublic FDA data

APLISOL

Product NDC
50090-1336
11-digit product format
500901336
Labeler code
50090
Product ID
50090-1336_d703ef2b-e51b-4d20-990b-3dd4161629a0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tuberculin Purified Protein Derivative
Dosage form
INJECTION
Route
INTRADERMAL
Labeler
A-S Medication Solutions
Application
BLA103782
Marketing category
BLA
Marketing start
2008-04-25
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

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
ndc (product): 50090-1336

Additional Listing Data#

Finished product
Yes
Brand name base
APLISOL
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TUBERCULIN PURIFIED PROTEIN DERIVATIVE5 [iU]/.1mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
I7L8FKN87JInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
313532Internal RxNorm lookup
798408Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
9f025046-850f-46c1-bdfd-245032144307Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-1336-02023-02-07C16284748780-1f386c64a-4370-0266-e053-dadaa90a7c1aAPLISOL
50090-1336-02023-01-30C16284748780-1f386c64a-4370-0266-e053-dadaa90a7c1aAPLISOL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-1336-0APLISOL1 in 1 CARTONINJECTION116
50090-1336-0APLISOL1 mL in 1 VIALINJECTION116

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-1336-0ML - Milliliter50090-133631ef93b6-b5d7-42a1-a6a9-59e235d21cea12018-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-1336APLISOL (TUBERCULIN PURIFIED PROTEIN DERIVATIVE) INJECTION [A-S MEDICATION SOLUTIONS]16Current NDC, Legacy NDC, 2 package rows20230511_9f025046-850f-46c1-bdfd-245032144307.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 SolutionPSN9f025046-850f-46c1-bdfd-24503214430716
313532purified protein derivative of tuberculin 5 UNT in 0.1 ML Injectable SolutionPSN9f025046-850f-46c1-bdfd-24503214430716
798408purified protein derivative of tuberculin 50 UNT/ML Injectable Solution [Aplisol]SBD9f025046-850f-46c1-bdfd-24503214430716
313532purified protein derivative of tuberculin 50 UNT/ML Injectable SolutionSCD9f025046-850f-46c1-bdfd-24503214430716
798408Aplisol 5 UNT per 0.1 ML Injectable SolutionSY9f025046-850f-46c1-bdfd-24503214430716
798408Aplisol 50 UNT/ML Injectable SolutionSY9f025046-850f-46c1-bdfd-24503214430716
313532purified protein derivative of tuberculin 5 UNT per 0.1 ML Injectable SolutionSY9f025046-850f-46c1-bdfd-24503214430716

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-1336-0500901336001 VIAL in 1 CARTON (50090-1336-0) / 1 mL in 1 VIAL1 vial2014-11-280000-00-00NoNoCurrent