dihydroergotamine mesylate

Generic: dihydroergotamine mesylate

Labeler: provepharm inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name dihydroergotamine mesylate
Generic Name dihydroergotamine mesylate
Labeler provepharm inc.
Dosage Form INJECTION, SOLUTION
Routes
INTRAMUSCULAR INTRAVENOUS SUBCUTANEOUS
Active Ingredients

dihydroergotamine mesylate 1 mg/mL

Manufacturer
Provepharm Inc.

Identifiers & Regulatory

Product NDC 81284-411
Product ID 81284-411_c3c6ccb7-6054-426c-8a56-d3c29dac13e2
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212046
Listing Expiration 2026-12-31
Marketing Start 2021-09-30

Pharmacologic Class

Classes
ergotamine derivative [epc] ergotamines [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 81284411
Hyphenated Format 81284-411

Supplemental Identifiers

RxCUI
861672
UPC
0381284411059
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 dihydroergotamine mesylate (source: ndc)
Generic Name dihydroergotamine mesylate (source: ndc)
Application Number ANDA212046 (source: ndc)
Routes
INTRAMUSCULAR INTRAVENOUS SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 1 mg/mL
source: ndc
Packaging
  • 5 AMPULE in 1 CARTON (81284-411-05) / 1 mL in 1 AMPULE (81284-411-00)
  • 10 AMPULE in 1 CARTON (81284-411-10) / 1 mL in 1 AMPULE (81284-411-00)
source: ndc

Packages (2)

81284-411-05 5 AMPULE in 1 CARTON (81284-411-05) / 1 mL in 1 AMPULE (81284-411-00) 81284-411-10 10 AMPULE in 1 CARTON (81284-411-10) / 1 mL in 1 AMPULE (81284-411-00)

Ingredients (1)

dihydroergotamine mesylate (1 mg/mL)

Linked Drug Pages (1)

Dihydroergotamine Mesylate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAMUSCULAR", "INTRAVENOUS", "SUBCUTANEOUS"], "spl_id": "c3c6ccb7-6054-426c-8a56-d3c29dac13e2", "openfda": {"upc": ["0381284411059"], "unii": ["81AXN7R2QT"], "rxcui": ["861672"], "spl_set_id": ["40b9ba9e-436e-444e-b078-01b12bb57ea7"], "manufacturer_name": ["Provepharm Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "5 AMPULE in 1 CARTON (81284-411-05)  / 1 mL in 1 AMPULE (81284-411-00)", "package_ndc": "81284-411-05", "marketing_start_date": "20210930"}, {"sample": false, "description": "10 AMPULE in 1 CARTON (81284-411-10)  / 1 mL in 1 AMPULE (81284-411-00)", "package_ndc": "81284-411-10", "marketing_start_date": "20210930"}], "brand_name": "Dihydroergotamine Mesylate", "product_id": "81284-411_c3c6ccb7-6054-426c-8a56-d3c29dac13e2", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Ergotamine Derivative [EPC]", "Ergotamines [CS]"], "product_ndc": "81284-411", "generic_name": "Dihydroergotamine Mesylate", "labeler_name": "Provepharm Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Dihydroergotamine Mesylate", "active_ingredients": [{"name": "DIHYDROERGOTAMINE MESYLATE", "strength": "1 mg/mL"}], "application_number": "ANDA212046", "marketing_category": "ANDA", "marketing_start_date": "20210930", "listing_expiration_date": "20261231"}