Prescription drug · ANDA
Droxidopa NDC 70771-1611
Droxidopa 300 mg/1 · Capsule · Oral · Zydus Lifesciences Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70771-1611-9 | 70771161109 | 90 CAPSULE in 1 BOTTLE (70771-1611-9)Marketed from Feb 19, 2021 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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
- Zydus Lifesciences Limited
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 211818
- Marketing start
- Listing expires
- Other FDA classes
- Catecholamines (Chemical structure)Increased Blood Pressure (Physiologic effect)
- Identifiers
- Product ID 70771-1611_2c98c6ce-80d6-4ec5-b0a8-8305bf6ac6ebSPL ID 2c98c6ce-80d6-4ec5-b0a8-8305bf6ac6ebSPL set ID e9894e44-99ff-471a-bcc2-bfecd55a6559RxCUI 1490026, 1490034, 1490038UNII J7A92W69L7UPC 0370771160990, 0370771161096, 0370771161195
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
N470771161109followed by a unit qualifier and the quantityPackage 70771-1611-09. 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 .
Other NDCs under ANDA 211818
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 | Zydus Lifesciences Limited | 70771-1609 |
| Droxidopa | Droxidopa 200 mg/1 | CapsuleOral | Zydus Lifesciences Limited | 70771-1610 |
| Droxidopa | Droxidopa 100 mg/1 | CapsuleOral | Zydus Pharmaceuticals USA Inc. | 70710-1389 |
| Droxidopa | Droxidopa 200 mg/1 | CapsuleOral | Zydus Pharmaceuticals USA Inc. | 70710-1390 |
| Droxidopa | Droxidopa 300 mg/1 | CapsuleOral | Zydus Pharmaceuticals USA Inc. | 70710-1391 |