Pomalidomide

Product NDC
60505-4498
11-digit product format
605054498
Labeler code
60505
Product ID
60505-4498_79028ff4-3130-88ed-e3fc-18a7d9a779b8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pomalidomide
Dosage form
CAPSULE
Route
ORAL
Labeler
Apotex Corp.
Application
ANDA210164
Marketing category
ANDA
Marketing start
2026-03-11
Substance
POMALIDOMIDE
Active strength
2 mg/1
Pharmacologic classes
Thalidomide Analog [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Pomalidomide
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
POMALIDOMIDE2 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiD2UX06XLB5
Rxcui1369718, 1369726, 1369730, 1369734

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
191ddea2-3e27-5c8d-dccc-59ef9a0abcf7Product name220250401

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60505-4498-1Pomalidomide100 in 1 BOTTLECAPSULE1002
60505-4498-2Pomalidomide21 in 1 BOTTLECAPSULE212

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60505-4498-2EA - Each60505-44984edb028b-3740-4fb8-ba71-7596e7b9f0c812026-04-20

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1369718pomalidomide 1 MG Oral CapsulePSNb1a1c713-d23b-5ede-1ae0-0bbba47221df2
1369726pomalidomide 2 MG Oral CapsulePSNb1a1c713-d23b-5ede-1ae0-0bbba47221df2
1369730pomalidomide 3 MG Oral CapsulePSNb1a1c713-d23b-5ede-1ae0-0bbba47221df2
1369734pomalidomide 4 MG Oral CapsulePSNb1a1c713-d23b-5ede-1ae0-0bbba47221df2
1369718pomalidomide 1 MG Oral CapsuleSCDb1a1c713-d23b-5ede-1ae0-0bbba47221df2
1369726pomalidomide 2 MG Oral CapsuleSCDb1a1c713-d23b-5ede-1ae0-0bbba47221df2
1369730pomalidomide 3 MG Oral CapsuleSCDb1a1c713-d23b-5ede-1ae0-0bbba47221df2
1369734pomalidomide 4 MG Oral CapsuleSCDb1a1c713-d23b-5ede-1ae0-0bbba47221df2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
60505-4498-160505449801100 in 1 BOTTLEHistorical
60505-4498-26050544980221 CAPSULE in 1 BOTTLE (60505-4498-2) 21 capsule2026-03-11NoNoHistorical