Home NDC 0025-0166 Synarel
Product NDC 0025-0166
11-digit product format 000250166
Labeler code 0025
Product ID 0025-0166_0ce07394-417b-4592-a051-8d63bdafbada
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name nafarelin acetate
Dosage form SPRAY, METERED
Route NASAL
Labeler Pfizer Laboratories Div Pfizer Inc
Application NDA019886
Marketing category NDA
Marketing start 1990-02-13
Substance NAFARELIN ACETATE
Active strength 2 mg/mL
Pharmacologic classes Gonadotropin Releasing Hormone Receptor Agonist [EPC], Gonadotropin Releasing Hormone Receptor Agonists [MoA]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N019886-001 SYNAREL NAFARELIN ACETATE EQ 0.2MG BASE/SPRAY SPRAY, METERED / NASAL RLD, RS 1990-02-13
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-01 22:54:32 2026-06 N019886-001 SYNAREL EQ 0.2MG BASE/SPRAY SPRAY, METERED / NASAL RLD, RS 1990-02-13 a50c72e98297…
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Synarel NAFARELIN ACETATE Pfizer Laboratories Div Pfizer Inc d0aa57cb-d2f4-46d7-af43-7c8b06aa81a6 2026-03-05 Warnings, Adverse reactions Exact identifier application applno (NDA): 019886 application number: NDA019886 ndc (product): 0025-0166
Additional Listing Data#
Finished product Yes
Brand name base Synarel
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength NAFARELIN ACETATE 2 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 8ENZ0QJW4H Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1797878 Internal RxNorm lookup 1797880 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0025-0166-08 Synarel 1 in 1 CARTON SPRAY, METERED 1 23 0025-0166-08 Synarel 8 mL in 1 BOTTLE, SPRAY SPRAY, METERED 8 23
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded NAFARELIN ACETATE ACTIVE INGREDIENT 8ENZ0QJW4H SYNAREL (NAFARELIN ACETATE) SPRAY, METERED [G.D. SEARLE LLC DIVISION OF PFIZER INC] 12 NAFARELIN ACTIVE MOIETY 1X0094V6JV SYNAREL (NAFARELIN ACETATE) SPRAY, METERED [G.D. SEARLE LLC DIVISION OF PFIZER INC] 12 ACETIC ACID INACTIVE INGREDIENT Q40Q9N063P SYNAREL (NAFARELIN ACETATE) SPRAY, METERED [G.D. SEARLE LLC DIVISION OF PFIZER INC] 12 BENZALKONIUM CHLORIDE INACTIVE INGREDIENT F5UM2KM3W7 SYNAREL (NAFARELIN ACETATE) SPRAY, METERED [G.D. SEARLE LLC DIVISION OF PFIZER INC] 12 HYDROCHLORIC ACID INACTIVE INGREDIENT QTT17582CB SYNAREL (NAFARELIN ACETATE) SPRAY, METERED [G.D. SEARLE LLC DIVISION OF PFIZER INC] 12 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I SYNAREL (NAFARELIN ACETATE) SPRAY, METERED [G.D. SEARLE LLC DIVISION OF PFIZER INC] 12 SORBITOL INACTIVE INGREDIENT 506T60A25R SYNAREL (NAFARELIN ACETATE) SPRAY, METERED [G.D. SEARLE LLC DIVISION OF PFIZER INC] 12 WATER INACTIVE INGREDIENT 059QF0KO0R SYNAREL (NAFARELIN ACETATE) SPRAY, METERED [G.D. SEARLE LLC DIVISION OF PFIZER INC] 12
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0025-0166 SYNAREL (NAFARELIN ACETATE) SPRAY, METERED [PFIZER LABORATORIES DIV PFIZER INC] 21 Current NDC, Legacy NDC, 2 package rows 20230301_d0aa57cb-d2f4-46d7-af43-7c8b06aa81a6.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 0025-0166-08 00025016608 1 BOTTLE, SPRAY in 1 CARTON (0025-0166-08) / 8 mL in 1 BOTTLE, SPRAY 1990-02-13 0000-00-00 No No Current