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

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

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown 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

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
103782AplisolTuberculin, Purified Protein Derivative351(a)Rx2026-08-01

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