NDC codes

FDA NDC Directory
Product NDC (as listed)72189-434Labeler and product segments. Claims need a package NDC.
Product NDC at billing width72189-0434Add 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
72189-434-0672189043406721890434066 TABLET in 1 BOTTLE (72189-434-06)Marketed from Mar 13, 2023

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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)
Zolmitriptan
Generic name (nonproprietary)
zolmitriptan
Active ingredients
Zolmitriptan — 2.5 mg/1
Dosage form
Tablet
Route
Oral
Labeler
Direct_RxNDC labeler code 72189
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 204041
Marketing start
Listing expires
Other FDA classes
Serotonin 1b Receptor Agonists (Mechanism)Serotonin 1d Receptor Agonists (Mechanism)
Identifiers
Product ID 72189-434_2c4d7dfd-fbd3-516b-e063-6394a90add1bSPL ID 2c4d7dfd-fbd3-516b-e063-6394a90add1bSPL set ID f6ca7d28-8322-f151-e053-6394a90a39b7RxCUI 200193UNII 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. Oral products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N472189043406 followed by a unit qualifier and the quantity

Package 72189-0434-06. 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 tablets are indicated for the acute treatment of migraine with or without aura in adults. Limitations of Use: Only use zolmitriptan tablets if a clear diagnosis of migraine has been established. If a patient has no response to zolmitriptan tablets treatment for the first migraine attack, reconsider the diagnosis of migraine before zolmitriptan tablets are administered to treat any subsequent attacks. Zolmitriptan tablets are not indicated for the prevention of migraine attacks. Safety and effectiveness of zolmitriptan tablets have not been established for cluster headache.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 72189-434

What is NDC 72189-434?
72189-434 is the product NDC for Zolmitriptan, Zolmitriptan 2.5 mg/1 tablet, listed with the FDA by Direct_Rx. 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?
Direct_Rx, NDC labeler code 72189. 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 2.5 mg/1Spray, MeteredNasalAmneal Pharmaceuticals NY LLC69238-235169238-2351-06
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 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 ANDA 204041

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

FDA NDC Directory listings under ANDA 204041
ProductStrengthForm · routeLabelerProduct NDC
ZolmitriptanZolmitriptan 2.5 mg/1TabletOralAjanta Pharma USA Inc.27241-021
ZolmitriptanZolmitriptan 5 mg/1TabletOralAjanta Pharma USA Inc.27241-022
ZolmitriptanZolmitriptan 5 mg/1TabletOralDirect_Rx72189-435
ZolmitriptanZolmitriptan 2.5 mg/1TabletOralAsclemed USA, Inc.76420-336
ZolmitriptanZolmitriptan 5 mg/1TabletOralAsclemed USA, Inc.76420-337

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