NDC 0025-0166

Synarel

Nafarelin Acetate

Synarel is a Nasal Spray, Metered in the Human Prescription Drug category. It is labeled and distributed by Pfizer Laboratories Div Pfizer Inc. The primary component is Nafarelin Acetate.

• Product ID: 0025-0166_34ad5a9a-caad-4431-8242-de13789731a8
• NDC: 0025-0166
• Product Type: Human Prescription Drug
• Proprietary Name: Synarel
• Generic Name: Nafarelin Acetate
• Dosage Form: Spray, Metered
• Route of Administration: NASAL
• Marketing Start Date: 1990-02-13
• Marketing Category: NDA / NDA
• Application Number: NDA019886
• Labeler Name: Pfizer Laboratories Div Pfizer Inc
• Substance Name: NAFARELIN ACETATE
• Active Ingredient Strength: 2 mg/mL
• Pharm Classes: Gonadotropin Releasing Hormone Receptor Agonist [EPC], Gonadotropin Releasing Hormone Receptor Agonists [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2023-12-31

Packaging

NDC 0025-0166-08

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

• Marketing Start Date: 1990-02-13
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0025-0166-08 [00025016608]

Synarel SPRAY, METERED

• Marketing Category: NDA
• Application Number: NDA019886
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 1990-02-13

Drug Details

Active Ingredients

Ingredient	Strength
NAFARELIN ACETATE	2 mg/mL

Pharmacological Class

• Gonadotropin Releasing Hormone Receptor Agonists [MoA]
• Gonadotropin Releasing Hormone Receptor Agonist [EPC]
• Gonadotropin Releasing Hormone Receptor Agonists [MoA]
• Gonadotropin Releasing Hormone Receptor Agonist [EPC]