Prescription drug · ANDA
Droxidopa NDC 0904-7394
Droxidopa 300 mg/1 · Capsule · Oral · MAJOR PHARMACEUTICALS
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0904-7394-89 | 00904739489 | 90 CAPSULE in 1 BOTTLE (0904-7394-89)Marketed from Dec 28, 2023 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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 — 300 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- MAJOR PHARMACEUTICALS
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 211741
- Marketing start
- Listing expires
- Other FDA classes
- Catecholamines (Chemical structure)Increased Blood Pressure (Physiologic effect)
- Identifiers
- Product ID 0904-7394_cf4934be-a283-4a81-9f26-3148a5e875a8SPL ID cf4934be-a283-4a81-9f26-3148a5e875a8SPL set ID 04b1f69d-ebba-43b9-8ecd-4f6be7c8a0a0RxCUI 1490026, 1490034, 1490038UNII J7A92W69L7UPC 0309047394890, 0309047393893
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
N400904739489followed by a unit qualifier and the quantityPackage 00904-7394-89. 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 capsules should be assessed periodically. Droxidopa capsules are indicated for the treatment of orthostatic dizziness, lightheadedness,or the “feeling that you are about to black…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 211741
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 100 mg/1 | CapsuleOral | MAJOR PHARMACEUTICALS | 0904-7392 |
| Droxidopa | Droxidopa 200 mg/1 | CapsuleOral | MAJOR PHARMACEUTICALS | 0904-7393 |
| Droxidopa | Droxidopa 200 mg/1 | CapsuleOral | Novadoz Pharmaceuticals LLC | 72205-073 |
| Droxidopa | Droxidopa 100 mg/1 | CapsuleOral | Novadoz Pharmaceuticals LLC | 72205-072 |
| Droxidopa | Droxidopa 300 mg/1 | CapsuleOral | Novadoz Pharmaceuticals LLC | 72205-074 |