synarel

Generic: nafarelin acetate

Labeler: pfizer laboratories div pfizer inc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name synarel
Generic Name nafarelin acetate
Labeler pfizer laboratories div pfizer inc
Dosage Form SPRAY, METERED
Routes
NASAL
Active Ingredients

nafarelin acetate 2 mg/mL

Manufacturer
Pfizer Laboratories Div Pfizer Inc

Identifiers & Regulatory

Product NDC 0025-0166
Product ID 0025-0166_0ce07394-417b-4592-a051-8d63bdafbada
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA019886
Listing Expiration 2027-12-31
Marketing Start 1990-02-13

Pharmacologic Class

Classes
gonadotropin releasing hormone receptor agonist [epc] gonadotropin releasing hormone receptor agonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 00250166
Hyphenated Format 0025-0166

Supplemental Identifiers

RxCUI
1797878 1797880
UNII
8ENZ0QJW4H

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 synarel (source: ndc)
Generic Name nafarelin acetate (source: ndc)
Application Number NDA019886 (source: ndc)
Routes
NASAL
source: ndc

Resolved Composition

Strengths
  • 2 mg/mL
source: ndc
Packaging
  • 1 BOTTLE, SPRAY in 1 CARTON (0025-0166-08) / 8 mL in 1 BOTTLE, SPRAY
source: ndc

Packages (1)

0025-0166-08 1 BOTTLE, SPRAY in 1 CARTON (0025-0166-08) / 8 mL in 1 BOTTLE, SPRAY

Ingredients (1)

nafarelin acetate (2 mg/mL)

Linked Drug Pages (1)

Synarel ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["NASAL"], "spl_id": "0ce07394-417b-4592-a051-8d63bdafbada", "openfda": {"unii": ["8ENZ0QJW4H"], "rxcui": ["1797878", "1797880"], "spl_set_id": ["d0aa57cb-d2f4-46d7-af43-7c8b06aa81a6"], "manufacturer_name": ["Pfizer Laboratories Div Pfizer Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, SPRAY in 1 CARTON (0025-0166-08)  / 8 mL in 1 BOTTLE, SPRAY", "package_ndc": "0025-0166-08", "marketing_start_date": "19900213"}], "brand_name": "Synarel", "product_id": "0025-0166_0ce07394-417b-4592-a051-8d63bdafbada", "dosage_form": "SPRAY, METERED", "pharm_class": ["Gonadotropin Releasing Hormone Receptor Agonist [EPC]", "Gonadotropin Releasing Hormone Receptor Agonists [MoA]"], "product_ndc": "0025-0166", "generic_name": "nafarelin acetate", "labeler_name": "Pfizer Laboratories Div Pfizer Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Synarel", "active_ingredients": [{"name": "NAFARELIN ACETATE", "strength": "2 mg/mL"}], "application_number": "NDA019886", "marketing_category": "NDA", "marketing_start_date": "19900213", "listing_expiration_date": "20271231"}