What is NDC 0025-0166?

0025-0166 is the product NDC for Synarel (nafarelin acetate), Nafarelin acetate 2 mg/mL spray, metered, listed with the FDA by Pfizer Laboratories Div Pfizer Inc. It has 1 package NDC, shown above in 10- and 11-digit form.

Pfizer Laboratories Div Pfizer Inc, NDC labeler code 0025. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Synarel?

None: this is the only finished product listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Synarel NDC 0025-0166 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)0025-0166Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00025-0166Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
0025-0166-08	00025016608	1 BOTTLE, SPRAY in 1 CARTON (0025-0166-08) / 8 mL in 1 BOTTLE, SPRAYMarketed from Feb 13, 1990

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules

Product information

Brand name (proprietary): Synarel
Generic name (nonproprietary): nafarelin acetate
Active ingredients: Nafarelin acetate — 2 mg/mL
Dosage form: Spray, Metered
Route: Nasal
Labeler: Pfizer Laboratories Div Pfizer IncNDC labeler code 0025
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 019886
Marketing start: Feb 13, 1990
Listing expires: Dec 31, 2027
Other FDA classes: Gonadotropin Releasing Hormone Receptor Agonists (Mechanism)
Identifiers: Product ID 0025-0166_0ce07394-417b-4592-a051-8d63bdafbadaSPL ID 0ce07394-417b-4592-a051-8d63bdafbadaSPL set ID d0aa57cb-d2f4-46d7-af43-7c8b06aa81a6RxCUI 1797878, 1797880UNII 8ENZ0QJW4H
Pharmacologic class: Gonadotropin Releasing Hormone Receptor Agonist

Billing references

What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.

HCPCS codeNo match

No HCPCS code in Med-Code's directory. Nasal products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N400025016608 followed by a unit qualifier and the quantity

Package 00025-0166-08. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier

Product label

Current FDA label (SPL), effective Mar 5, 2026.

Indications (excerpt from the label)

INDICATIONS AND USAGE FOR CENTRAL PRECOCIOUS PUBERTY (For Endometriosis, See Reverse Side ) SYNAREL is indicated for treatment of central precocious puberty (CPP) (gonadotropin-dependent precocious puberty) in children of both sexes. The diagnosis of central precocious puberty (CPP) is suspected when premature development of secondary sexual characteristics occurs at or before the age of 8 years in girls and 9 years in boys, and is accompanied by significant advancement of bone age and/or a poor adult height prediction. The diagnosis should be confirmed by pubertal gonadal sex steroid levels and a pubertal LH response to stimulation by native GnRH. Pelvic ultrasound assessment in girls usual…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0025-0166

What is NDC 0025-0166?: 0025-0166 is the product NDC for Synarel (nafarelin acetate), Nafarelin acetate 2 mg/mL spray, metered, listed with the FDA by Pfizer Laboratories Div Pfizer Inc. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Synarel (Nafarelin acetate).
What is the active ingredient?: Nafarelin acetate.
Who is the labeler?: Pfizer Laboratories Div Pfizer Inc, NDC labeler code 0025. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Synarel?: None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Synarel (Nafarelin acetate) NDC 0025-0166