zolmitriptan

Generic: zolmitriptan

Labeler: zydus pharmaceuticals usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name zolmitriptan
Generic Name zolmitriptan
Labeler zydus pharmaceuticals usa inc.
Dosage Form TABLET, ORALLY DISINTEGRATING
Routes
ORAL
Active Ingredients

zolmitriptan 5 mg/1

Manufacturer
Zydus Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 68382-717
Product ID 68382-717_c8bbe1ff-34e4-4638-ac8a-00b1ceb2f310
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202890
Listing Expiration 2026-12-31
Marketing Start 2013-05-16

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 68382717
Hyphenated Format 68382-717

Supplemental Identifiers

RxCUI
284201 351134
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 zolmitriptan (source: ndc)
Generic Name zolmitriptan (source: ndc)
Application Number ANDA202890 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 100 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (68382-717-01)
  • 30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (68382-717-06)
  • 1000 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (68382-717-10)
  • 90 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (68382-717-16)
  • 10 BLISTER PACK in 1 CARTON (68382-717-77) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (68382-717-30)
  • 1 BLISTER PACK in 1 CARTON (68382-717-82) / 3 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (68382-717-87)
source: ndc

Packages (6)

68382-717-01 100 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (68382-717-01) 68382-717-06 30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (68382-717-06) 68382-717-10 1000 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (68382-717-10) 68382-717-16 90 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (68382-717-16) 68382-717-77 10 BLISTER PACK in 1 CARTON (68382-717-77) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (68382-717-30) 68382-717-82 1 BLISTER PACK in 1 CARTON (68382-717-82) / 3 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (68382-717-87)

Ingredients (1)

zolmitriptan (5 mg/1)

Linked Drug Pages (1)

Zolmitriptan ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "c8bbe1ff-34e4-4638-ac8a-00b1ceb2f310", "openfda": {"nui": ["N0000175763", "N0000175764", "N0000175765"], "unii": ["2FS66TH3YW"], "rxcui": ["284201", "351134"], "spl_set_id": ["7fc95729-2f5d-4d5c-b26c-3a13854f73e3"], "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": ["Zydus Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (68382-717-01)", "package_ndc": "68382-717-01", "marketing_start_date": "20130516"}, {"sample": false, "description": "30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (68382-717-06)", "package_ndc": "68382-717-06", "marketing_start_date": "20130516"}, {"sample": false, "description": "1000 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (68382-717-10)", "package_ndc": "68382-717-10", "marketing_start_date": "20130516"}, {"sample": false, "description": "90 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (68382-717-16)", "package_ndc": "68382-717-16", "marketing_start_date": "20130516"}, {"sample": false, "description": "10 BLISTER PACK in 1 CARTON (68382-717-77)  / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (68382-717-30)", "package_ndc": "68382-717-77", "marketing_start_date": "20130516"}, {"sample": false, "description": "1 BLISTER PACK in 1 CARTON (68382-717-82)  / 3 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (68382-717-87)", "package_ndc": "68382-717-82", "marketing_start_date": "20130516"}], "brand_name": "Zolmitriptan", "product_id": "68382-717_c8bbe1ff-34e4-4638-ac8a-00b1ceb2f310", "dosage_form": "TABLET, ORALLY DISINTEGRATING", "pharm_class": ["Serotonin 1b Receptor Agonists [MoA]", "Serotonin 1d Receptor Agonists [MoA]", "Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]"], "product_ndc": "68382-717", "generic_name": "Zolmitriptan", "labeler_name": "Zydus Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Zolmitriptan", "active_ingredients": [{"name": "ZOLMITRIPTAN", "strength": "5 mg/1"}], "application_number": "ANDA202890", "marketing_category": "ANDA", "marketing_start_date": "20130516", "listing_expiration_date": "20261231"}