ojjaara

Generic: momelotinib

Labeler: glaxosmithkline llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name ojjaara
Generic Name momelotinib
Labeler glaxosmithkline llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

momelotinib dihydrochloride monohydrate 150 mg/1

Manufacturer
GlaxoSmithKline LLC

Identifiers & Regulatory

Product NDC 81864-102
Product ID 81864-102_26b81ffa-710b-4a24-abc8-0255797add74
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA216873
Listing Expiration 2026-12-31
Marketing Start 2023-09-15

Pharmacologic Class

Classes
breast cancer resistance protein inhibitors [moa] kinase inhibitor [epc] kinase inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 81864102
Hyphenated Format 81864-102

Supplemental Identifiers

RxCUI
2665210 2665216 2665218 2665220 2665222 2665224
UPC
0381864103305 0381864102308 0381864101301
UNII
LDX8893L5D

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 ojjaara (source: ndc)
Generic Name momelotinib (source: ndc)
Application Number NDA216873 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 150 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (81864-102-30)
source: ndc

Packages (1)

81864-102-30 30 TABLET in 1 BOTTLE (81864-102-30)

Ingredients (1)

momelotinib dihydrochloride monohydrate (150 mg/1)

Linked Drug Pages (1)

Ojjaara ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "26b81ffa-710b-4a24-abc8-0255797add74", "openfda": {"upc": ["0381864103305", "0381864102308", "0381864101301"], "unii": ["LDX8893L5D"], "rxcui": ["2665210", "2665216", "2665218", "2665220", "2665222", "2665224"], "spl_set_id": ["4a672fd1-eb7b-4aa9-9b23-845e4b5dc400"], "manufacturer_name": ["GlaxoSmithKline LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (81864-102-30)", "package_ndc": "81864-102-30", "marketing_start_date": "20230915"}], "brand_name": "Ojjaara", "product_id": "81864-102_26b81ffa-710b-4a24-abc8-0255797add74", "dosage_form": "TABLET", "pharm_class": ["Breast Cancer Resistance Protein Inhibitors [MoA]", "Kinase Inhibitor [EPC]", "Kinase Inhibitors [MoA]"], "product_ndc": "81864-102", "generic_name": "Momelotinib", "labeler_name": "GlaxoSmithKline LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ojjaara", "active_ingredients": [{"name": "MOMELOTINIB DIHYDROCHLORIDE MONOHYDRATE", "strength": "150 mg/1"}], "application_number": "NDA216873", "marketing_category": "NDA", "marketing_start_date": "20230915", "listing_expiration_date": "20261231"}