Pomalidomide

Product NDC
63850-0134
11-digit product format
638500134
Labeler code
63850
Product ID
63850-0134_0169dbda-53df-4cd9-b989-ff7544f1bdf5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pomalidomide
Dosage form
CAPSULE
Route
ORAL
Labeler
Natco Pharma Limited
Application
ANDA210111
Marketing category
ANDA
Marketing start
2025-11-01
Substance
POMALIDOMIDE
Active strength
4 mg/1
Pharmacologic classes
Thalidomide Analog [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
POMALIDOMIDE4 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
63850-0134-1Pomalidomide21 in 1 BOTTLECAPSULE211
63850-0134-2Pomalidomide100 in 1 BOTTLECAPSULE1001

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1369718pomalidomide 1 MG Oral CapsulePSN0169dbda-53df-4cd9-b989-ff7544f1bdf51
1369726pomalidomide 2 MG Oral CapsulePSN0169dbda-53df-4cd9-b989-ff7544f1bdf51
1369730pomalidomide 3 MG Oral CapsulePSN0169dbda-53df-4cd9-b989-ff7544f1bdf51
1369734pomalidomide 4 MG Oral CapsulePSN0169dbda-53df-4cd9-b989-ff7544f1bdf51
1369718pomalidomide 1 MG Oral CapsuleSCD0169dbda-53df-4cd9-b989-ff7544f1bdf51
1369726pomalidomide 2 MG Oral CapsuleSCD0169dbda-53df-4cd9-b989-ff7544f1bdf51
1369730pomalidomide 3 MG Oral CapsuleSCD0169dbda-53df-4cd9-b989-ff7544f1bdf51
1369734pomalidomide 4 MG Oral CapsuleSCD0169dbda-53df-4cd9-b989-ff7544f1bdf51

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
63850-0134-16385001340121 CAPSULE in 1 BOTTLE (63850-0134-1) 21 capsule2025-11-01NoNoHistorical
63850-0134-263850013402100 CAPSULE in 1 BOTTLE (63850-0134-2) 100 capsule2025-11-01NoNoHistorical