NDC codes

FDA NDC Directory
Product NDC (as listed)69097-503Labeler and product segments. Claims need a package NDC.
Product NDC at billing width69097-0503Add 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
69097-503-2769097050327690970503278 VIAL in 1 KIT (69097-503-27) / 1 mL in 1 VIALMarketed from May 23, 2020
69097-503-3169097050331690970503311 VIAL in 1 KIT (69097-503-31) / 1 mL in 1 VIALMarketed from May 23, 2020

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)
Dihydroergotamine Mesylate Nasal
Generic name (nonproprietary)
dihydroergotamine mesylate nasal
Active ingredients
Dihydroergotamine mesylate — 4 mg/mL
Dosage form
Spray, Metered
Route
Nasal
Labeler
Cipla USA Inc.NDC labeler code 69097
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 212907
Marketing start
Listing expires
Other FDA classes
Ergotamines (Chemical structure)
Identifiers
Product ID 69097-503_68a5f507-1f3a-412d-8321-1e8d74cc31bcSPL ID 68a5f507-1f3a-412d-8321-1e8d74cc31bcSPL set ID 1ecb2311-eee3-4230-a019-a3496308cff1RxCUI 861668UNII 81AXN7R2QT
Pharmacologic class
Ergotamine Derivative

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

N469097050327 followed by a unit qualifier and the quantity

Package 69097-0503-27. 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 . This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE Dihydroergotamine mesylate nasal spray is indicated for the acute treatment of migraine headaches with or without aura. Dihydroergotamine mesylate nasal spray is not intended for the prophylactic therapy of migraine or for the management of hemiplegic or basilar migraine.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 69097-503

What is NDC 69097-503?
69097-503 is the product NDC for Dihydroergotamine Mesylate Nasal, Dihydroergotamine mesylate 4 mg/mL spray, metered, listed with the FDA by Cipla USA Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Dihydroergotamine Mesylate Nasal.
What is the active ingredient?
Dihydroergotamine mesylate.
Who is the labeler?
Cipla USA Inc., NDC labeler code 69097. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Dihydroergotamine Mesylate Nasal?
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.

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