Prescription drug · ANDA
Droxidopa NDC 67877-704
Droxidopa 100 mg/1 · Capsule · Oral · Ascend Laboratories, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 67877-704-05 | 67877070405 | 500 CAPSULE in 1 BOTTLE (67877-704-05)Marketed from Feb 19, 2021 | |
| 67877-704-90 | 67877070490 | 90 CAPSULE in 1 BOTTLE (67877-704-90)Marketed from Feb 19, 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)
- Droxidopa
- Generic name (nonproprietary)
- droxidopa
- Active ingredients
- Droxidopa — 100 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Ascend Laboratories, LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 213911
- Marketing start
- Listing expires
- Other FDA classes
- Catecholamines (Chemical structure)Increased Blood Pressure (Physiologic effect)
- Identifiers
- Product ID 67877-704_15a3d787-2fea-4455-9932-dd2eae43ac5fSPL ID 15a3d787-2fea-4455-9932-dd2eae43ac5fSPL set ID 6091958e-f04e-47c0-9eef-9c204df4edd9RxCUI 1490026, 1490034, 1490038UNII J7A92W69L7UPC 0367877704906, 0367877705903, 0367877706900
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
N467877070405followed by a unit qualifier and the quantityPackage 67877-0704-05. 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)
Droxidopa capsules 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 droxidopa capsules should be assessed periodically. Droxidopa capsule is indicated for the treatment of orthostatic dizziness, light headedness, or the “feeling that you are about to black …
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 213911
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 | Ascend Laboratories, LLC | 67877-705 |
| Droxidopa | Droxidopa 300 mg/1 | CapsuleOral | Ascend Laboratories, LLC | 67877-706 |
| Droxidopa | Droxidopa 100 mg/1 | CapsuleOral | CivicaScript LLC | 82249-551 |
| Droxidopa | Droxidopa 200 mg/1 | CapsuleOral | CivicaScript LLC | 82249-552 |
| Droxidopa | Droxidopa 300 mg/1 | CapsuleOral | CivicaScript LLC | 82249-554 |