pomalidomide

Generic: pomalidomide

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

Drug Facts

Product Profile

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

pomalidomide 4 mg/1

Manufacturer
Natco Pharma Limited

Identifiers & Regulatory

Product NDC 63850-0134
Product ID 63850-0134_0169dbda-53df-4cd9-b989-ff7544f1bdf5
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210111
Listing Expiration 2026-12-31
Marketing Start 2025-11-01

Pharmacologic Class

Established (EPC)
thalidomide analog [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 638500134
Hyphenated Format 63850-0134

Supplemental Identifiers

RxCUI
1369718 1369726 1369730 1369734
UPC
0363850013416 0363850013317 0363850013126 0363850013225 0363850013218 0363850013324 0363850013423 0363850013119
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 ANDA210111 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 4 mg/1
source: ndc
Packaging
  • 21 CAPSULE in 1 BOTTLE (63850-0134-1)
  • 100 CAPSULE in 1 BOTTLE (63850-0134-2)
source: ndc

Packages (2)

63850-0134-1 21 CAPSULE in 1 BOTTLE (63850-0134-1) 63850-0134-2 100 CAPSULE in 1 BOTTLE (63850-0134-2)

Ingredients (1)

pomalidomide (4 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": "0169dbda-53df-4cd9-b989-ff7544f1bdf5", "openfda": {"nui": ["N0000184014"], "upc": ["0363850013416", "0363850013317", "0363850013126", "0363850013225", "0363850013218", "0363850013324", "0363850013423", "0363850013119"], "unii": ["D2UX06XLB5"], "rxcui": ["1369718", "1369726", "1369730", "1369734"], "spl_set_id": ["0169dbda-53df-4cd9-b989-ff7544f1bdf5"], "pharm_class_epc": ["Thalidomide Analog [EPC]"], "manufacturer_name": ["Natco Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "21 CAPSULE in 1 BOTTLE (63850-0134-1)", "package_ndc": "63850-0134-1", "marketing_start_date": "20251101"}, {"sample": false, "description": "100 CAPSULE in 1 BOTTLE (63850-0134-2)", "package_ndc": "63850-0134-2", "marketing_start_date": "20251101"}], "brand_name": "Pomalidomide", "product_id": "63850-0134_0169dbda-53df-4cd9-b989-ff7544f1bdf5", "dosage_form": "CAPSULE", "pharm_class": ["Thalidomide Analog [EPC]"], "product_ndc": "63850-0134", "generic_name": "Pomalidomide", "labeler_name": "Natco Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Pomalidomide", "active_ingredients": [{"name": "POMALIDOMIDE", "strength": "4 mg/1"}], "application_number": "ANDA210111", "marketing_category": "ANDA", "marketing_start_date": "20251101", "listing_expiration_date": "20261231"}