zomig

Generic: zolmitriptan

Labeler: amneal pharmaceuticals llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name zomig
Generic Name zolmitriptan
Labeler amneal pharmaceuticals llc
Dosage Form SPRAY, METERED
Routes
NASAL
Active Ingredients

zolmitriptan 2.5 mg/1

Manufacturer
Amneal Pharmaceuticals LLC

Identifiers & Regulatory

Product NDC 64896-083
Product ID 64896-083_0cf4f3c1-ad30-431f-8afc-4e31019cdabf
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA021450
Listing Expiration 2026-12-31
Marketing Start 2024-07-15

Pharmacologic Class

Established (EPC)
serotonin-1b and serotonin-1d receptor agonist [epc]
Mechanism of Action
serotonin 1b receptor agonists [moa] serotonin 1d receptor agonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 64896083
Hyphenated Format 64896-083

Supplemental Identifiers

RxCUI
402000 402169 1483677 1483679
UNII
2FS66TH3YW
NUI
N0000175763 N0000175764 N0000175765

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 zomig (source: ndc)
Generic Name zolmitriptan (source: ndc)
Application Number NDA021450 (source: ndc)
Routes
NASAL
source: ndc

Resolved Composition

Strengths
  • 2.5 mg/1
source: ndc
Packaging
  • 6 BOTTLE, SPRAY in 1 CARTON (64896-083-12) / 1 SPRAY, METERED in 1 BOTTLE, SPRAY
source: ndc

Packages (1)

64896-083-12 6 BOTTLE, SPRAY in 1 CARTON (64896-083-12) / 1 SPRAY, METERED in 1 BOTTLE, SPRAY

Ingredients (1)

zolmitriptan (2.5 mg/1)

Linked Drug Pages (1)

ZOMIG ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["NASAL"], "spl_id": "0cf4f3c1-ad30-431f-8afc-4e31019cdabf", "openfda": {"nui": ["N0000175763", "N0000175764", "N0000175765"], "unii": ["2FS66TH3YW"], "rxcui": ["402000", "402169", "1483677", "1483679"], "spl_set_id": ["2438c223-605b-4885-afc3-a6794f190f89"], "pharm_class_epc": ["Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]"], "pharm_class_moa": ["Serotonin 1b Receptor Agonists [MoA]", "Serotonin 1d Receptor Agonists [MoA]"], "manufacturer_name": ["Amneal Pharmaceuticals LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "6 BOTTLE, SPRAY in 1 CARTON (64896-083-12)  / 1 SPRAY, METERED in 1 BOTTLE, SPRAY", "package_ndc": "64896-083-12", "marketing_start_date": "20240715"}], "brand_name": "ZOMIG", "product_id": "64896-083_0cf4f3c1-ad30-431f-8afc-4e31019cdabf", "dosage_form": "SPRAY, METERED", "pharm_class": ["Serotonin 1b Receptor Agonists [MoA]", "Serotonin 1d Receptor Agonists [MoA]", "Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]"], "product_ndc": "64896-083", "generic_name": "Zolmitriptan", "labeler_name": "Amneal Pharmaceuticals LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ZOMIG", "active_ingredients": [{"name": "ZOLMITRIPTAN", "strength": "2.5 mg/1"}], "application_number": "NDA021450", "marketing_category": "NDA", "marketing_start_date": "20240715", "listing_expiration_date": "20261231"}