Zavzpret (zavegepant) NDC 0069-3500

NDC codes

FDA NDC Directory

Product NDC (as listed)0069-3500Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00069-3500Add 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
0069-3500-02	00069350002	6 BLISTER PACK in 1 CARTON (0069-3500-02) / 1 VIAL, SINGLE-DOSE in 1 BLISTER PACK (0069-3500-01) / .1 mL in 1 VIAL, SINGLE-DOSEMarketed from Jun 1, 2023

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): Zavzpret
Generic name (nonproprietary): zavegepant
Active ingredients: Zavegepant hydrochloride — 10 mg/.1mL
Dosage form: Spray
Route: Nasal
Labeler: Pfizer Laboratories Div Pfizer Inc
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 216386
Marketing start: Jun 1, 2023
Listing expires: Dec 31, 2026
Other FDA classes: Calcitonin Gene-related Peptide Receptor Antagonists (Mechanism)
Identifiers: Product ID 0069-3500_d6d7cbe0-0760-4b2b-8323-5b6882832a60SPL ID d6d7cbe0-0760-4b2b-8323-5b6882832a60SPL set ID 9c4a7aec-daef-4961-ba77-92f4b58be780RxCUI 2637974, 2637980UNII 000QCM6HAL
Pharmacologic class: Calcitonin Gene-related Peptide Receptor Antagonist

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

N400069350002 followed by a unit qualifier and the quantity

Package 00069-3500-02. 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

Label details couldn’t be retrieved right now. Open the label on DailyMed.

Other NDCs under NDA 216386

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under NDA 216386
Product	Strength	Form · route	Labeler	Product NDC
Zavzpretzavegepant	Zavegepant hydrochloride 10 mg/.1mL	SprayNasal	U.S. Pharmaceuticals	63539-135