dihydroergotamine mesylate

Generic: dihydroergotamine mesylate

Labeler: gland pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name dihydroergotamine mesylate
Generic Name dihydroergotamine mesylate
Labeler gland pharma limited
Dosage Form INJECTION
Routes
INTRAMUSCULAR INTRAVENOUS SUBCUTANEOUS
Active Ingredients

dihydroergotamine mesylate 1 mg/mL

Manufacturer
Gland Pharma Limited

Identifiers & Regulatory

Product NDC 68083-466
Product ID 68083-466_a1a6aeb0-fb61-46bf-8b3f-7ed1a9cc21ae
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA215623
Listing Expiration 2026-12-31
Marketing Start 2023-08-18

Pharmacologic Class

Classes
ergotamine derivative [epc] ergotamines [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68083466
Hyphenated Format 68083-466

Supplemental Identifiers

RxCUI
861672
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 ANDA215623 (source: ndc)
Routes
INTRAMUSCULAR INTRAVENOUS SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 1 mg/mL
source: ndc
Packaging
  • 10 AMPULE in 1 CARTON (68083-466-10) / 1 mL in 1 AMPULE
source: ndc

Packages (1)

68083-466-10 10 AMPULE in 1 CARTON (68083-466-10) / 1 mL in 1 AMPULE

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": "a1a6aeb0-fb61-46bf-8b3f-7ed1a9cc21ae", "openfda": {"unii": ["81AXN7R2QT"], "rxcui": ["861672"], "spl_set_id": ["07a9112c-8c04-4849-8cb3-9463f58731d2"], "manufacturer_name": ["Gland Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 AMPULE in 1 CARTON (68083-466-10)  / 1 mL in 1 AMPULE", "package_ndc": "68083-466-10", "marketing_start_date": "20230818"}], "brand_name": "Dihydroergotamine Mesylate", "product_id": "68083-466_a1a6aeb0-fb61-46bf-8b3f-7ed1a9cc21ae", "dosage_form": "INJECTION", "pharm_class": ["Ergotamine Derivative [EPC]", "Ergotamines [CS]"], "product_ndc": "68083-466", "generic_name": "Dihydroergotamine Mesylate", "labeler_name": "Gland Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Dihydroergotamine Mesylate", "active_ingredients": [{"name": "DIHYDROERGOTAMINE MESYLATE", "strength": "1 mg/mL"}], "application_number": "ANDA215623", "marketing_category": "ANDA", "marketing_start_date": "20230818", "listing_expiration_date": "20261231"}