Pomalidomide

Product NDC
59651-196
11-digit product format
596510196
Labeler code
59651
Product ID
59651-196_1539fbf9-8281-4c7b-827b-9f53b50d9042
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pomalidomide
Dosage form
CAPSULE
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA210249
Marketing category
ANDA
Marketing start
2020-10-30
Substance
POMALIDOMIDE
Active strength
3 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
POMALIDOMIDE3 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
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59651-196-01Pomalidomide100 in 1 BOTTLECAPSULE1001
59651-196-21Pomalidomide21 in 1 BOTTLECAPSULE211

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1369718pomalidomide 1 MG Oral CapsulePSN1539fbf9-8281-4c7b-827b-9f53b50d90421
1369726pomalidomide 2 MG Oral CapsulePSN1539fbf9-8281-4c7b-827b-9f53b50d90421
1369730pomalidomide 3 MG Oral CapsulePSN1539fbf9-8281-4c7b-827b-9f53b50d90421
1369734pomalidomide 4 MG Oral CapsulePSN1539fbf9-8281-4c7b-827b-9f53b50d90421
1369718pomalidomide 1 MG Oral CapsuleSCD1539fbf9-8281-4c7b-827b-9f53b50d90421
1369726pomalidomide 2 MG Oral CapsuleSCD1539fbf9-8281-4c7b-827b-9f53b50d90421
1369730pomalidomide 3 MG Oral CapsuleSCD1539fbf9-8281-4c7b-827b-9f53b50d90421
1369734pomalidomide 4 MG Oral CapsuleSCD1539fbf9-8281-4c7b-827b-9f53b50d90421

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
59651-196-0159651019601100 CAPSULE in 1 BOTTLE (59651-196-01) 100 capsule2020-10-30NoNoCurrent
59651-196-215965101962121 CAPSULE in 1 BOTTLE (59651-196-21) 21 capsule2020-10-30NoNoCurrent