tarpeyo

Generic: budesonide

Labeler: calliditas therapeutics ab
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name tarpeyo
Generic Name budesonide
Labeler calliditas therapeutics ab
Dosage Form CAPSULE, DELAYED RELEASE
Routes
ORAL
Active Ingredients

budesonide 4 mg/1

Manufacturer
Calliditas Therapeutics AB

Identifiers & Regulatory

Product NDC 81749-004
Product ID 81749-004_48e9b876-94c8-7c9f-e063-6294a90adcef
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA215935
Listing Expiration 2027-12-31
Marketing Start 2021-12-15

Pharmacologic Class

Established (EPC)
corticosteroid [epc]
Mechanism of Action
corticosteroid hormone receptor agonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 81749004
Hyphenated Format 81749-004

Supplemental Identifiers

RxCUI
2587883 2587889
UNII
Q3OKS62Q6X
NUI
N0000175576 N0000175450

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 tarpeyo (source: ndc)
Generic Name budesonide (source: ndc)
Application Number NDA215935 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 4 mg/1
source: ndc
Packaging
  • 120 CAPSULE, DELAYED RELEASE in 1 BOTTLE (81749-004-01)
source: ndc

Packages (1)

81749-004-01 120 CAPSULE, DELAYED RELEASE in 1 BOTTLE (81749-004-01)

Ingredients (1)

budesonide (4 mg/1)

Linked Drug Pages (1)

Tarpeyo ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "48e9b876-94c8-7c9f-e063-6294a90adcef", "openfda": {"nui": ["N0000175576", "N0000175450"], "unii": ["Q3OKS62Q6X"], "rxcui": ["2587883", "2587889"], "spl_set_id": ["938cada4-d6bf-4252-836f-dd40f9eadb4d"], "pharm_class_epc": ["Corticosteroid [EPC]"], "pharm_class_moa": ["Corticosteroid Hormone Receptor Agonists [MoA]"], "manufacturer_name": ["Calliditas Therapeutics AB"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "120 CAPSULE, DELAYED RELEASE in 1 BOTTLE (81749-004-01)", "package_ndc": "81749-004-01", "marketing_start_date": "20211215"}], "brand_name": "Tarpeyo", "product_id": "81749-004_48e9b876-94c8-7c9f-e063-6294a90adcef", "dosage_form": "CAPSULE, DELAYED RELEASE", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "81749-004", "generic_name": "budesonide", "labeler_name": "Calliditas Therapeutics AB", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Tarpeyo", "active_ingredients": [{"name": "BUDESONIDE", "strength": "4 mg/1"}], "application_number": "NDA215935", "marketing_category": "NDA", "marketing_start_date": "20211215", "listing_expiration_date": "20271231"}