Prescription drug · NDA
Northera (Droxidopa) NDC 67386-821
Droxidopa 200 mg/1 · Capsule · Oral · Lundbeck Pharmaceuticals LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 67386-821-19 | 6738608211967386082119 | 90 CAPSULE in 1 BOTTLE (67386-821-19)Marketed from Sep 1, 2014 |
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)
- Northera
- Generic name (nonproprietary)
- droxidopa
- Active ingredients
- Droxidopa — 200 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Lundbeck Pharmaceuticals LLCNDC labeler code 67386
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 203202
- Marketing start
- Listing expires
- Other FDA classes
- Catecholamines (Chemical structure)Increased Blood Pressure (Physiologic effect)
- Identifiers
- Product ID 67386-821_5e69b39c-3254-43bc-ae4d-258222a964d5SPL ID 5e69b39c-3254-43bc-ae4d-258222a964d5SPL set ID 2179f02c-48d7-48eb-8007-5ae43d8d16bcRxCUI 1490026, 1490032, 1490034, 1490036, 1490038, 1490040UNII J7A92W69L7
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. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N467386082119followed by a unit qualifier and the quantityPackage 67386-0821-19. 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)
NORTHERA is indicated for the treatment of orthostatic dizziness, lightheadedness, or the “feeling that you are about to black out” in adult patients with symptomatic neurogenic orthostatic hypotension (nOH) caused by primary autonomic failure (Parkinson's disease [PD], multiple system atrophy, and pure autonomic failure), dopamine beta-hydroxylase deficiency, and non-diabetic autonomic neuropathy. Effectiveness beyond 2 weeks of treatment has not been established. The continued effectiveness of NORTHERA should be assessed periodically. NORTHERA is indicated for the treatment of orthostatic dizziness, lightheadedness, or the “feeling that you are about to black out” in adult patients with sy…
Excerpt only. Read the full label for complete information.
About NDC 67386-821
- What is NDC 67386-821?
- 67386-821 is the product NDC for Northera (droxidopa), Droxidopa 200 mg/1 capsule, listed with the FDA by Lundbeck Pharmaceuticals LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Northera (Droxidopa).
- What is the active ingredient?
- Droxidopa.
- Who is the labeler?
- Lundbeck Pharmaceuticals LLC, NDC labeler code 67386. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Northera?
- 2 other product NDCs are listed under this name. See all Northera NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Northera products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Northeradroxidopa | Droxidopa 100 mg/1 | CapsuleOral | Lundbeck Pharmaceuticals LLC | 67386-820 | 67386-0820-19 |
| Northeradroxidopa | Droxidopa 300 mg/1 | CapsuleOral | Lundbeck Pharmaceuticals LLC | 67386-822 | 67386-0822-19 |
Other NDCs under NDA 203202
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 |
|---|---|---|---|---|
| Northeradroxidopa | Droxidopa 100 mg/1 | CapsuleOral | Lundbeck Pharmaceuticals LLC | 67386-820 |
| Northeradroxidopa | Droxidopa 300 mg/1 | CapsuleOral | Lundbeck Pharmaceuticals LLC | 67386-822 |