NDC codes

FDA NDC Directory
Product NDC (as listed)69238-2351Labeler and product segments. Claims need a package NDC.
Product NDC at billing width69238-2351Add 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 NDC11-digit (billing)PackageCopy
69238-2351-669238235106692382351066 BOTTLE, SPRAY in 1 CARTON (69238-2351-6) / 1 SPRAY, METERED in 1 BOTTLE, SPRAYMarketed from Jul 15, 2024

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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)
Zolmitriptan
Generic name (nonproprietary)
zolmitriptan
Active ingredients
Zolmitriptan — 2.5 mg/1
Dosage form
Spray, Metered
Route
Nasal
Labeler
Amneal Pharmaceuticals NY LLCNDC labeler code 69238
Product type
Prescription drug
Marketing category
NDA authorized genericApplication NDA 021450
Marketing start
Listing expires
Other FDA classes
Serotonin 1b Receptor Agonists (Mechanism)Serotonin 1d Receptor Agonists (Mechanism)
Identifiers
Product ID 69238-2351_3481678d-2990-4288-bec4-f402cad1b8d6SPL ID 3481678d-2990-4288-bec4-f402cad1b8d6SPL set ID 05a40502-149d-41bd-966e-771e937a955bRxCUI 402000, 1483677UNII 2FS66TH3YW
Pharmacologic class
Serotonin-1b and Serotonin-1d 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

N469238235106 followed by a unit qualifier and the quantity

Package 69238-2351-06. 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 .

Indications (excerpt from the label)

ZOLMITRIPTAN NASAL SPRAY is indicated for the acute treatment of migraine with or without aura in adults and pediatric patients 12 years of age and older. Limitations of Use Only use ZOLMITRIPTAN NASAL SPRAY if a clear diagnosis of migraine has been established. If a patient has no response to ZOLMITRIPTAN NASAL SPRAY treatment for the first migraine attack, reconsider the diagnosis of migraine before ZOLMITRIPTAN NASAL SPRAY is administered to treat any subsequent attacks. ZOLMITRIPTAN NASAL SPRAY is not indicated for the prevention of migraine attacks. Safety and effectiveness of ZOLMITRIPTAN NASAL SPRAY have not been established for cluster headache. Not recommended in patients with moder…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 69238-2351

What is NDC 69238-2351?
69238-2351 is the product NDC for Zolmitriptan, Zolmitriptan 2.5 mg/1 spray, metered, listed with the FDA by Amneal Pharmaceuticals NY LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Zolmitriptan.
What is the active ingredient?
Zolmitriptan.
Who is the labeler?
Amneal Pharmaceuticals NY LLC, NDC labeler code 69238. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Zolmitriptan?
37 other product NDCs are listed under this name. See all Zolmitriptan NDCs.
Is there a related HCPCS / J-code?
Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Zolmitriptan NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
ZolmitriptanZolmitriptan 5 mg/1Spray, MeteredNasalAmneal Pharmaceuticals NY LLC69238-235269238-2352-06
ZolmitriptanZolmitriptan 2.5 mg/1Tablet, Orally disintegratingOralAlembic Pharmaceuticals Inc.62332-18162332-0181-06
ZolmitriptanZolmitriptan 5 mg/1Tablet, Orally disintegratingOralAlembic Pharmaceuticals Inc.62332-18262332-0182-03
ZolmitriptanZolmitriptan 2.5 mg/1Tablet, Film coatedOralAlembic Pharmaceuticals Inc.62332-46262332-0462-06
ZolmitriptanZolmitriptan 5 mg/1Tablet, Film coatedOralAlembic Pharmaceuticals Inc.62332-46362332-0463-03
ZolmitriptanZolmitriptan 2.5 mg/1TabletOralDirect_Rx72189-43472189-0434-06
ZolmitriptanZolmitriptan 5 mg/1TabletOralDirect_Rx72189-43572189-0435-03
zolmitriptanZolmitriptan 5 mg/1SprayNasalPadagis Israel Pharmaceuticals Ltd45802-71145802-0711-91
zolmitriptanZolmitriptan 5 mg/1SprayNasalBryant Ranch Prepack63629-957563629-9575-01
zolmitriptanZolmitriptan 5 mg/1SprayNasalBryant Ranch Prepack71335-294771335-2947-01

All 38 Zolmitriptan NDCs

Other NDCs under NDA 021450

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

FDA NDC Directory listings under NDA 021450
ProductStrengthForm · routeLabelerProduct NDC
ZolmitriptanZolmitriptan 5 mg/1Spray, MeteredNasalAmneal Pharmaceuticals NY LLC69238-2352

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