Prescription drug · ANDA
Dihydroergotamine mesylate NDC 72888-096
Dihydroergotamine mesylate 4 mg/mL · Spray · Nasal · Advagen Pharma Ltd
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72888-096-19 | 7288800961972888009619 | 8 KIT in 1 KIT (72888-096-19) / 1 VIAL, GLASS in 1 KIT (72888-096-18) / 1 mL in 1 VIAL, GLASSMarketed from Jun 23, 2023 | |
| 72888-096-34 | 7288800963472888009634 | 1 VIAL, GLASS in 1 KIT (72888-096-34) / 1 mL in 1 VIAL, GLASSMarketed from Jun 23, 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)
- Dihydroergotamine mesylate
- Generic name (nonproprietary)
- dihydroergotamine mesylate
- Active ingredients
- Dihydroergotamine mesylate — 4 mg/mL
- Dosage form
- Spray
- Route
- Nasal
- Labeler
- Advagen Pharma LtdNDC labeler code 72888
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 216881
- Marketing start
- Listing expires
- Other FDA classes
- Ergotamines (Chemical structure)
- Identifiers
- Product ID 72888-096_47c7c595-73f1-4f7c-e063-6394a90afd8fSPL ID 47c7c595-73f1-4f7c-e063-6394a90afd8fSPL set ID 65f8c60d-9213-48ac-8233-acc5d44548f4RxCUI 861668UNII 81AXN7R2QTUPC 0372888096346, 0372888096186
- 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
N472888009619followed by a unit qualifier and the quantityPackage 72888-0096-19. 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.
About NDC 72888-096
- What is NDC 72888-096?
- 72888-096 is the product NDC for Dihydroergotamine mesylate, Dihydroergotamine mesylate 4 mg/mL spray, listed with the FDA by Advagen Pharma Ltd. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Dihydroergotamine mesylate.
- What is the active ingredient?
- Dihydroergotamine mesylate.
- Who is the labeler?
- Advagen Pharma Ltd, NDC labeler code 72888. 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?
- 10 other product NDCs are listed under this name. See all Dihydroergotamine mesylate NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Dihydroergotamine mesylate products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Dihydroergotamine Mesylate | Dihydroergotamine mesylate 4 mg/mL | Spray, MeteredNasal | Somerset Therapeutics, LLC | 70069-880 | 70069-0880-08 |
| Dihydroergotamine mesylate | Dihydroergotamine mesylate 4 mg/mL | SprayNasal | Trifluent Pharma, LLC | 73352-096 | 73352-0096-19 |
| dihydroergotamine mesylate | Dihydroergotamine mesylate 1 mg/mL | Injection, SolutionIntramuscular, Intravenous, Subcutaneous | Baxter Healthcare Corporation | 36000-300 | 36000-0300-10 |
| Dihydroergotamine Mesylate | Dihydroergotamine mesylate 1 mg/mL | InjectionIntramuscular, Intravenous, Subcutaneous | Gland Pharma Limited | 68083-466 | 68083-0466-10 |
| Dihydroergotamine Mesylate | Dihydroergotamine mesylate 1 mg/mL | InjectionIntramuscular, Intravenous, Subcutaneous | Hikma Pharmaceuticals USA Inc. | 0143-9151 | 00143-9151-10 |
| Dihydroergotamine Mesylate | Dihydroergotamine mesylate 1 mg/mL | Injection, SolutionIntramuscular, Intravenous, Subcutaneous | Milla Pharmaceuticals Inc. | 71357-013 | 71357-0013-0571357-0013-10 |
| Dihydroergotamine Mesylate | Dihydroergotamine mesylate 1 mg/mL | Injection, SolutionIntramuscular, Intravenous, Subcutaneous | Provepharm Inc. | 81284-411 | 81284-0411-0581284-0411-10 |
| Dihydroergotamine Mesylate | Dihydroergotamine mesylate 4 mg/mL | SprayNasal | Hikma Pharmaceuticals USA Inc. | 24201-463 | 24201-0463-08 |
| Dihydroergotamine Mesylate | Dihydroergotamine mesylate 1 mg/mL | InjectionIntramuscular, Intravenous, Subcutaneous | Hikma Pharmaceuticals USA Inc. | 0143-9273 | 00143-9273-10 |
| Dihydroergotamine Mesylate | Dihydroergotamine mesylate 4 mg/mL | SprayNasal | Oceanside Pharmaceuticals | 68682-357 | 68682-0357-10 |
Other NDCs under ANDA 216881
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Dihydroergotamine mesylate | Dihydroergotamine mesylate 4 mg/mL | SprayNasal | Trifluent Pharma, LLC | 73352-096 |