dihydroergotamine mesylate nasal (69097-503)

Drug Facts

Product Profile

Brand Name dihydroergotamine mesylate nasal

Generic Name dihydroergotamine mesylate nasal

Labeler cipla usa inc.

Dosage Form SPRAY, METERED

Routes

NASAL

Active Ingredients

dihydroergotamine mesylate 4 mg/mL

Manufacturer

Cipla USA Inc.

Identifiers & Regulatory

Product NDC 69097-503

Product ID 69097-503_68a5f507-1f3a-412d-8321-1e8d74cc31bc

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA212907

Listing Expiration 2026-12-31

Marketing Start 2020-05-23

Pharmacologic Class

Classes

ergotamine derivative [epc] ergotamines [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 69097503

Hyphenated Format 69097-503

Supplemental Identifiers

RxCUI

861668

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 nasal (source: ndc)

Generic Name dihydroergotamine mesylate nasal (source: ndc)

Application Number ANDA212907 (source: ndc)

Routes

NASAL

source: ndc

Resolved Composition

Strengths

4 mg/mL

source: ndc

Packaging

8 VIAL in 1 KIT (69097-503-27) / 1 mL in 1 VIAL
1 VIAL in 1 KIT (69097-503-31) / 1 mL in 1 VIAL

source: ndc

Packages (2)

69097-503-27 8 VIAL in 1 KIT (69097-503-27) / 1 mL in 1 VIAL 69097-503-31 1 VIAL in 1 KIT (69097-503-31) / 1 mL in 1 VIAL

Ingredients (1)

dihydroergotamine mesylate (4 mg/mL)

Linked Drug Pages (1)

Dihydroergotamine Mesylate Nasal ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["NASAL"], "spl_id": "68a5f507-1f3a-412d-8321-1e8d74cc31bc", "openfda": {"unii": ["81AXN7R2QT"], "rxcui": ["861668"], "spl_set_id": ["1ecb2311-eee3-4230-a019-a3496308cff1"], "manufacturer_name": ["Cipla USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "8 VIAL in 1 KIT (69097-503-27)  / 1 mL in 1 VIAL", "package_ndc": "69097-503-27", "marketing_start_date": "20200523"}, {"sample": false, "description": "1 VIAL in 1 KIT (69097-503-31)  / 1 mL in 1 VIAL", "package_ndc": "69097-503-31", "marketing_start_date": "20200523"}], "brand_name": "Dihydroergotamine Mesylate Nasal", "product_id": "69097-503_68a5f507-1f3a-412d-8321-1e8d74cc31bc", "dosage_form": "SPRAY, METERED", "pharm_class": ["Ergotamine Derivative [EPC]", "Ergotamines [CS]"], "product_ndc": "69097-503", "generic_name": "Dihydroergotamine Mesylate Nasal", "labeler_name": "Cipla USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Dihydroergotamine Mesylate Nasal", "active_ingredients": [{"name": "DIHYDROERGOTAMINE MESYLATE", "strength": "4 mg/mL"}], "application_number": "ANDA212907", "marketing_category": "ANDA", "marketing_start_date": "20200523", "listing_expiration_date": "20261231"}