pomalidomide

Generic: pomalidomide

Labeler: aurobindo pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name pomalidomide
Generic Name pomalidomide
Labeler aurobindo pharma limited
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

pomalidomide 1 mg/1

Manufacturer
Aurobindo Pharma Limited

Identifiers & Regulatory

Product NDC 59651-194
Product ID 59651-194_1539fbf9-8281-4c7b-827b-9f53b50d9042
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210249
Listing Expiration 2027-12-31
Marketing Start 2020-10-30

Pharmacologic Class

Established (EPC)
thalidomide analog [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 59651194
Hyphenated Format 59651-194

Supplemental Identifiers

RxCUI
1369718 1369726 1369730 1369734
UNII
D2UX06XLB5
NUI
N0000184014

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name pomalidomide (source: ndc)
Generic Name pomalidomide (source: ndc)
Application Number ANDA210249 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1 mg/1
source: ndc
Packaging
  • 100 CAPSULE in 1 BOTTLE (59651-194-01)
  • 21 CAPSULE in 1 BOTTLE (59651-194-21)
source: ndc

Packages (2)

59651-194-01 100 CAPSULE in 1 BOTTLE (59651-194-01) 59651-194-21 21 CAPSULE in 1 BOTTLE (59651-194-21)

Ingredients (1)

pomalidomide (1 mg/1)

Linked Drug Pages (1)

Pomalidomide ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "1539fbf9-8281-4c7b-827b-9f53b50d9042", "openfda": {"nui": ["N0000184014"], "unii": ["D2UX06XLB5"], "rxcui": ["1369718", "1369726", "1369730", "1369734"], "spl_set_id": ["1539fbf9-8281-4c7b-827b-9f53b50d9042"], "pharm_class_epc": ["Thalidomide Analog [EPC]"], "manufacturer_name": ["Aurobindo Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE (59651-194-01)", "package_ndc": "59651-194-01", "marketing_start_date": "20201030"}, {"sample": false, "description": "21 CAPSULE in 1 BOTTLE (59651-194-21)", "package_ndc": "59651-194-21", "marketing_start_date": "20201030"}], "brand_name": "Pomalidomide", "product_id": "59651-194_1539fbf9-8281-4c7b-827b-9f53b50d9042", "dosage_form": "CAPSULE", "pharm_class": ["Thalidomide Analog [EPC]"], "product_ndc": "59651-194", "generic_name": "Pomalidomide", "labeler_name": "Aurobindo Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Pomalidomide", "active_ingredients": [{"name": "POMALIDOMIDE", "strength": "1 mg/1"}], "application_number": "ANDA210249", "marketing_category": "ANDA", "marketing_start_date": "20201030", "listing_expiration_date": "20271231"}