Prescription drug · ANDA
Dihydroergotamine Mesylate Nasal NDC 69097-503
Dihydroergotamine mesylate 4 mg/mL · Spray, Metered · Nasal · Cipla USA Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69097-503-27 | 6909705032769097050327 | 8 VIAL in 1 KIT (69097-503-27) / 1 mL in 1 VIALMarketed from May 23, 2020 | |
| 69097-503-31 | 6909705033169097050331 | 1 VIAL in 1 KIT (69097-503-31) / 1 mL in 1 VIALMarketed from May 23, 2020 |
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 Nasal
- Generic name (nonproprietary)
- dihydroergotamine mesylate nasal
- Active ingredients
- Dihydroergotamine mesylate — 4 mg/mL
- Dosage form
- Spray, Metered
- Route
- Nasal
- Labeler
- Cipla USA Inc.NDC labeler code 69097
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 212907
- Marketing start
- Listing expires
- Other FDA classes
- Ergotamines (Chemical structure)
- Identifiers
- Product ID 69097-503_68a5f507-1f3a-412d-8321-1e8d74cc31bcSPL ID 68a5f507-1f3a-412d-8321-1e8d74cc31bcSPL set ID 1ecb2311-eee3-4230-a019-a3496308cff1RxCUI 861668UNII 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
N469097050327followed by a unit qualifier and the quantityPackage 69097-0503-27. 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 69097-503
- What is NDC 69097-503?
- 69097-503 is the product NDC for Dihydroergotamine Mesylate Nasal, Dihydroergotamine mesylate 4 mg/mL spray, metered, listed with the FDA by Cipla USA Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Dihydroergotamine Mesylate Nasal.
- What is the active ingredient?
- Dihydroergotamine mesylate.
- Who is the labeler?
- Cipla USA Inc., NDC labeler code 69097. 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 Nasal?
- 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.