Prescription drug · ANDA
Dihydroergotamine Mesylate NDC 81284-411
Dihydroergotamine mesylate 1 mg/mL · Injection, Solution · Intramuscular, Intravenous, Subcutaneous · Provepharm Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 81284-411-05 | 8128404110581284041105 | 5 AMPULE in 1 CARTON (81284-411-05) / 1 mL in 1 AMPULE (81284-411-00)Marketed from Sep 30, 2021 | |
| 81284-411-10 | 8128404111081284041110 | 10 AMPULE in 1 CARTON (81284-411-10) / 1 mL in 1 AMPULE (81284-411-00)Marketed from Sep 30, 2021 |
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 — 1 mg/mL
- Dosage form
- Injection, Solution
- Route
- Intramuscular, Intravenous, Subcutaneous
- Labeler
- Provepharm Inc.NDC labeler code 81284
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 212046
- Marketing start
- Listing expires
- Other FDA classes
- Ergotamines (Chemical structure)
- Identifiers
- Product ID 81284-411_c3c6ccb7-6054-426c-8a56-d3c29dac13e2SPL ID c3c6ccb7-6054-426c-8a56-d3c29dac13e2SPL set ID 40b9ba9e-436e-444e-b078-01b12bb57ea7RxCUI 861672UNII 81AXN7R2QTUPC 0381284411059
- 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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- Administration
Drug administration (CPT 96360–96549)
When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.
- NDC on a medical claim
N481284041105followed by a unit qualifier and the quantityPackage 81284-0411-05. 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 Injection, USP is indicated for the acute treatment of migraine headaches with or without aura and the acute treatment of cluster headache episodes.
Excerpt only. Read the full label for complete information.
About NDC 81284-411
- What is NDC 81284-411?
- 81284-411 is the product NDC for Dihydroergotamine Mesylate, Dihydroergotamine mesylate 1 mg/mL injection, solution, listed with the FDA by Provepharm Inc.. 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?
- Provepharm Inc., NDC labeler code 81284. 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 4 mg/mL | SprayNasal | Advagen Pharma Ltd | 72888-096 | 72888-0096-1972888-0096-34 |
| 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 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 212046
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 1 mg/mL | Injection, SolutionIntramuscular, Intravenous, Subcutaneous | Milla Pharmaceuticals Inc. | 71357-013 |