atzumi

Generic: dihydroergotamine mesylate

Labeler: satsuma pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name atzumi
Generic Name dihydroergotamine mesylate
Labeler satsuma pharmaceuticals, inc.
Dosage Form POWDER
Routes
NASAL
Active Ingredients

dihydroergotamine mesylate 5.2 mg/1

Manufacturer
Satsuma Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 76978-101
Product ID 76978-101_3b0b0981-a681-4c0c-91fb-b662277e92ad
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA217901
Listing Expiration 2026-12-31
Marketing Start 2025-04-30

Pharmacologic Class

Classes
ergotamine derivative [epc] ergotamines [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 76978101
Hyphenated Format 76978-101

Supplemental Identifiers

RxCUI
2714187 2714192
UPC
0376978101019
UNII
81AXN7R2QT

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 atzumi (source: ndc)
Generic Name dihydroergotamine mesylate (source: ndc)
Application Number NDA217901 (source: ndc)
Routes
NASAL
source: ndc

Resolved Composition

Strengths
  • 5.2 mg/1
source: ndc
Packaging
  • 8 BOTTLE, UNIT-DOSE in 1 CARTON (76978-101-08) / 1 POWDER in 1 BOTTLE, UNIT-DOSE
  • 1 BOTTLE, UNIT-DOSE in 1 CARTON (76978-101-11) / 1 POWDER in 1 BOTTLE, UNIT-DOSE
source: ndc

Packages (2)

76978-101-08 8 BOTTLE, UNIT-DOSE in 1 CARTON (76978-101-08) / 1 POWDER in 1 BOTTLE, UNIT-DOSE 76978-101-11 1 BOTTLE, UNIT-DOSE in 1 CARTON (76978-101-11) / 1 POWDER in 1 BOTTLE, UNIT-DOSE

Ingredients (1)

dihydroergotamine mesylate (5.2 mg/1)

Linked Drug Pages (1)

ATZUMI ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["NASAL"], "spl_id": "3b0b0981-a681-4c0c-91fb-b662277e92ad", "openfda": {"upc": ["0376978101019"], "unii": ["81AXN7R2QT"], "rxcui": ["2714187", "2714192"], "spl_set_id": ["0982a44a-dc0c-75c0-e063-6394a90a6d6c"], "manufacturer_name": ["Satsuma Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "8 BOTTLE, UNIT-DOSE in 1 CARTON (76978-101-08)  / 1 POWDER in 1 BOTTLE, UNIT-DOSE", "package_ndc": "76978-101-08", "marketing_start_date": "20250430"}, {"sample": false, "description": "1 BOTTLE, UNIT-DOSE in 1 CARTON (76978-101-11)  / 1 POWDER in 1 BOTTLE, UNIT-DOSE", "package_ndc": "76978-101-11", "marketing_start_date": "20250430"}], "brand_name": "ATZUMI", "product_id": "76978-101_3b0b0981-a681-4c0c-91fb-b662277e92ad", "dosage_form": "POWDER", "pharm_class": ["Ergotamine Derivative [EPC]", "Ergotamines [CS]"], "product_ndc": "76978-101", "generic_name": "DIHYDROERGOTAMINE MESYLATE", "labeler_name": "Satsuma Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ATZUMI", "active_ingredients": [{"name": "DIHYDROERGOTAMINE MESYLATE", "strength": "5.2 mg/1"}], "application_number": "NDA217901", "marketing_category": "NDA", "marketing_start_date": "20250430", "listing_expiration_date": "20261231"}