Prescription drug · NDA
Trudhesa (Dihydroergotamine mesylate) NDC 77530-725
Dihydroergotamine mesylate 4 mg/mL · Spray, Metered · Nasal · Impel Pharmaceuticals LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 77530-725-00 | 7753007250077530072500 | 1 VIAL, GLASS in 1 CARTON (77530-725-00) / 1 mL in 1 VIAL, GLASSMarketed from Sep 24, 2021 · Sample package | |
| 77530-725-04 | 7753007250477530072504 | 4 VIAL, GLASS in 1 CARTON (77530-725-04) / 1 mL in 1 VIAL, GLASSMarketed from Sep 24, 2021 | |
| 77530-725-06 | 7753007250677530072506 | 6 VIAL, GLASS in 1 CARTON (77530-725-06) / 1 mL in 1 VIAL, GLASSMarketed from Sep 1, 2026 · Sample package |
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)
- Trudhesa
- Generic name (nonproprietary)
- dihydroergotamine mesylate
- Active ingredients
- Dihydroergotamine mesylate — 4 mg/mL
- Dosage form
- Spray, Metered
- Route
- Nasal
- Labeler
- Impel Pharmaceuticals LLCNDC labeler code 77530
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 213436
- Marketing start
- Listing expires
- Other FDA classes
- Ergotamines (Chemical structure)
- Identifiers
- Product ID 77530-725_ff3340ed-c740-497d-9959-c369049030d0SPL ID ff3340ed-c740-497d-9959-c369049030d0SPL set ID b81397b0-910d-4eb4-8fee-a9a3c9d94d63RxCUI 2569836, 2569842UNII 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
N477530072500followed by a unit qualifier and the quantityPackage 77530-0725-00. 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)
TRUDHESA is indicated for the acute treatment of migraine with or without aura in adults. Limitations of Use TRUDHESA is not indicated for the preventive treatment of migraine. TRUDHESA is not indicated for the management of hemiplegic or basilar migraine. TRUDHESA is an ergotamine derivative indicated for the acute treatment of migraine with or without aura in adults. ( 1 ) Limitations of Use: TRUDHESA is not indicated for the preventive treatment of migraine or for the management of hemiplegic or basilar migraine. ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 77530-725
- What is NDC 77530-725?
- 77530-725 is the product NDC for Trudhesa (dihydroergotamine mesylate), Dihydroergotamine mesylate 4 mg/mL spray, metered, listed with the FDA by Impel Pharmaceuticals LLC. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Trudhesa (Dihydroergotamine mesylate).
- What is the active ingredient?
- Dihydroergotamine mesylate.
- Who is the labeler?
- Impel Pharmaceuticals LLC, NDC labeler code 77530. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Trudhesa?
- 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.