Pomalidomide

Product NDC
59651-195
11-digit product format
596510195
Labeler code
59651
Product ID
59651-195_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
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
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
59651-195-01Pomalidomide100 in 1 BOTTLECAPSULE1001
59651-195-21Pomalidomide21 in 1 BOTTLECAPSULE211

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59651-195-21EA - Each59651-195aaf26aa6-e914-4a0d-baf8-2f5f39b98e9e12026-03-17

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
59651-195-0159651019501100 CAPSULE in 1 BOTTLE (59651-195-01) 100 capsule2020-10-30NoNoCurrent
59651-195-215965101952121 CAPSULE in 1 BOTTLE (59651-195-21) 21 capsule2020-10-30NoNoCurrent