pomalidomide

Generic: pomalidomide

Labeler: breckenridge pharmaceutical, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name pomalidomide
Generic Name pomalidomide
Labeler breckenridge pharmaceutical, inc.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

pomalidomide 3 mg/1

Manufacturer
Breckenridge Pharmaceutical, Inc.

Identifiers & Regulatory

Product NDC 51991-344
Product ID 51991-344_78d28501-a544-4099-9b7b-f69d8ea2ee34
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210111
Listing Expiration 2027-12-31
Marketing Start 2026-02-28

Pharmacologic Class

Established (EPC)
thalidomide analog [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 51991344
Hyphenated Format 51991-344

Supplemental Identifiers

RxCUI
1369718 1369726 1369730 1369734
UPC
0351991346210 0351991342212 0351991343219 0351991344216
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
  • 3 mg/1
source: ndc
Packaging
  • 100 CAPSULE in 1 BOTTLE (51991-344-01)
  • 21 CAPSULE in 1 BOTTLE, PLASTIC (51991-344-21)
source: ndc

Packages (2)

51991-344-01 100 CAPSULE in 1 BOTTLE (51991-344-01) 51991-344-21 21 CAPSULE in 1 BOTTLE, PLASTIC (51991-344-21)

Ingredients (1)

pomalidomide (3 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": "78d28501-a544-4099-9b7b-f69d8ea2ee34", "openfda": {"nui": ["N0000184014"], "upc": ["0351991346210", "0351991342212", "0351991343219", "0351991344216"], "unii": ["D2UX06XLB5"], "rxcui": ["1369718", "1369726", "1369730", "1369734"], "spl_set_id": ["41400b90-b64e-447b-90f3-1cad58050eba"], "pharm_class_epc": ["Thalidomide Analog [EPC]"], "manufacturer_name": ["Breckenridge Pharmaceutical, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE (51991-344-01)", "package_ndc": "51991-344-01", "marketing_start_date": "20260228"}, {"sample": false, "description": "21 CAPSULE in 1 BOTTLE, PLASTIC (51991-344-21)", "package_ndc": "51991-344-21", "marketing_start_date": "20260228"}], "brand_name": "Pomalidomide", "product_id": "51991-344_78d28501-a544-4099-9b7b-f69d8ea2ee34", "dosage_form": "CAPSULE", "pharm_class": ["Thalidomide Analog [EPC]"], "product_ndc": "51991-344", "generic_name": "Pomalidomide", "labeler_name": "Breckenridge Pharmaceutical, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Pomalidomide", "active_ingredients": [{"name": "POMALIDOMIDE", "strength": "3 mg/1"}], "application_number": "ANDA210111", "marketing_category": "ANDA", "marketing_start_date": "20260228", "listing_expiration_date": "20271231"}