Prescription drug · NDA
Atzumi (Dihydroergotamine mesylate) NDC 76978-101
Dihydroergotamine mesylate 5.2 mg/1 · Powder · Nasal · Satsuma Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 76978-101-08 | 7697801010876978010108 | 8 BOTTLE, UNIT-DOSE in 1 CARTON (76978-101-08) / 1 POWDER in 1 BOTTLE, UNIT-DOSEMarketed from Apr 30, 2025 | |
| 76978-101-11 | 7697801011176978010111 | 1 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
N476978010108followed by a unit qualifier and the quantityPackage 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.
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.