Propylthiouracil

Product NDC
62135-606
11-digit product format
621350606
Labeler code
62135
Product ID
62135-606_0d6cc91d-1da2-25ae-e063-6394a90aa6a0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Propylthiouracil
Dosage form
TABLET
Route
ORAL
Labeler
Chartwell RX, LLC
Application
ANDA080016
Marketing category
ANDA
Marketing start
1982-01-01
Substance
PROPYLTHIOURACIL
Active strength
50 mg/1
Pharmacologic classes
Thyroid Hormone Synthesis Inhibitor [EPC], Thyroid Hormone Synthesis Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PROPYLTHIOURACIL50 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii721M9407IY
Rxcui198175

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5199f153-e97c-2898-8204-85c73892d5a5Product name220240513

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62135-606-90Propylthiouracil90 in 1 BOTTLETABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62135-606-90EA - Each62135-606ccc33e89-eaaa-4ec0-a53e-66103f28550212024-01-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62135-606PROPYLTHIOURACIL TABLET [CHARTWELL RX, LLC]1Current NDC, 1 package rows20231227_53c5f586-3e72-479d-89ba-379683c8f6ba.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198175propylthiouracil 50 MG Oral TabletPSN53c5f586-3e72-479d-89ba-379683c8f6ba1
198175propylthiouracil 50 MG Oral TabletSCD53c5f586-3e72-479d-89ba-379683c8f6ba1
198175PTU 50 MG Oral TabletSY53c5f586-3e72-479d-89ba-379683c8f6ba1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
62135-606-906213506069090 TABLET in 1 BOTTLE (62135-606-90) 90 tablet2023-12-19NoNoHistorical