NDC codes

FDA NDC Directory
Product NDC (as listed)76978-101Labeler and product segments. Claims need a package NDC.
Product NDC at billing width76978-0101Add 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
76978-101-0876978010108769780101088 BOTTLE, UNIT-DOSE in 1 CARTON (76978-101-08) / 1 POWDER in 1 BOTTLE, UNIT-DOSEMarketed from Apr 30, 2025
76978-101-1176978010111769780101111 BOTTLE, UNIT-DOSE in 1 CARTON (76978-101-11) / 1 POWDER in 1 BOTTLE, UNIT-DOSEMarketed from Apr 30, 2025

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)
Atzumi
Generic name (nonproprietary)
dihydroergotamine mesylate
Active ingredients
Dihydroergotamine mesylate — 5.2 mg/1
Dosage form
Powder
Route
Nasal
Labeler
Satsuma Pharmaceuticals, Inc.NDC labeler code 76978
Product type
Prescription drug
Marketing category
NDA — New Drug ApplicationApplication NDA 217901
Marketing start
Listing expires
Other FDA classes
Ergotamines (Chemical structure)
Identifiers
Product ID 76978-101_08783e1b-71b6-4187-8adc-ab72bf9c2c8cSPL ID 08783e1b-71b6-4187-8adc-ab72bf9c2c8cSPL set ID 0982a44a-dc0c-75c0-e063-6394a90a6d6cRxCUI 2714187, 2714192UNII 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

N476978010108 followed by a unit qualifier and the quantity

Package 76978-0101-08. 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 . This label includes a boxed warning.

Indications (excerpt from the label)

ATZUMI is indicated for the acute treatment of migraine with or without aura in adults. ATZUMI is an ergotamine derivative indicated for the acute treatment of migraine with or without aura in adults. ( 1 ) Limitations of Use ATZUMI is not indicated for the preventive treatment of migraine or for the management of hemiplegic migraine or migraine with brainstem aura. ( 1 ) Limitations of Use ATZUMI is not indicated for the preventive treatment of migraine. ATZUMI is not indicated for the management of hemiplegic migraine or migraine with brainstem aura.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 76978-101

What is NDC 76978-101?
76978-101 is the product NDC for Atzumi (dihydroergotamine mesylate), Dihydroergotamine mesylate 5.2 mg/1 powder, listed with the FDA by Satsuma Pharmaceuticals, Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Atzumi (Dihydroergotamine mesylate).
What is the active ingredient?
Dihydroergotamine mesylate.
Who is the labeler?
Satsuma Pharmaceuticals, Inc., NDC labeler code 76978. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Atzumi?
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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