Prescription drug · ANDA
Droxidopa NDC 51407-765
Droxidopa 100 mg/1 · Capsule · Oral · Golden State Medical Supply, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 51407-765-90 | 51407076590 | 90 CAPSULE in 1 BOTTLE (51407-765-90)Marketed from Apr 18, 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)
- Droxidopa
- Generic name (nonproprietary)
- droxidopa
- Active ingredients
- Droxidopa — 100 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 214017
- Marketing start
- Listing expires
- Other FDA classes
- Catecholamines (Chemical structure)Increased Blood Pressure (Physiologic effect)
- Identifiers
- Product ID 51407-765_fe08a2df-651b-bac7-e053-6294a90aaf20SPL ID fe08a2df-651b-bac7-e053-6294a90aaf20SPL set ID fe08aebb-b390-d176-e053-6394a90a6be7RxCUI 1490026, 1490034, 1490038UNII J7A92W69L7UPC 0351407766908, 0351407765901, 0351407767905
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
N451407076590followed by a unit qualifier and the quantityPackage 51407-0765-90. 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)
Droxidopa capsules are 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 Droxidopa should be assessed periodically. Droxidopa Capsules are indicated for the treatment of orthostatic dizziness, lightheadedness, or the “feeling that you are about to black out” in…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 214017
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 |
|---|---|---|---|---|
| Droxidopa | Droxidopa 200 mg/1 | CapsuleOral | Golden State Medical Supply, Inc. | 51407-766 |
| Droxidopa | Droxidopa 300 mg/1 | CapsuleOral | Golden State Medical Supply, Inc. | 51407-767 |
| Droxidopa | Droxidopa 200 mg/1 | CapsuleOral | ScieGen Pharmaceuticals Inc | 50228-430 |
| Droxidopa | Droxidopa 100 mg/1 | CapsuleOral | ScieGen Pharmaceuticals Inc | 50228-429 |
| Droxidopa | Droxidopa 300 mg/1 | CapsuleOral | ScieGen Pharmaceuticals Inc | 50228-431 |