Prescription drug · ANDA
Droxidopa NDC 82249-554
Droxidopa 300 mg/1 · Capsule · Oral · CivicaScript LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 82249-554-90 | 8224905549082249055490 | 90 CAPSULE in 1 BOTTLE (82249-554-90)Marketed from Mar 3, 2025 |
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 — 300 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- CivicaScript LLCNDC labeler code 82249
- 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 82249-554_f6dce609-c7d7-48a3-83bb-32ecf00f973fSPL ID f6dce609-c7d7-48a3-83bb-32ecf00f973fSPL set ID f6dce609-c7d7-48a3-83bb-32ecf00f973fRxCUI 1490026, 1490034, 1490038UNII J7A92W69L7UPC 0382249554903
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
N482249055490followed by a unit qualifier and the quantityPackage 82249-0554-90. 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 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.
About NDC 82249-554
- What is NDC 82249-554?
- 82249-554 is the product NDC for Droxidopa, Droxidopa 300 mg/1 capsule, listed with the FDA by CivicaScript LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Droxidopa.
- What is the active ingredient?
- Droxidopa.
- Who is the labeler?
- CivicaScript LLC, NDC labeler code 82249. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Droxidopa?
- 41 other product NDCs are listed under this name. See all Droxidopa NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Droxidopa products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Droxidopa | Droxidopa 100 mg/1 | CapsuleOral | CivicaScript LLC | 82249-551 | 82249-0551-90 |
| Droxidopa | Droxidopa 200 mg/1 | CapsuleOral | CivicaScript LLC | 82249-552 | 82249-0552-90 |
| droxidopa | Droxidopa 100 mg/1 | CapsuleOral | Slate Run Pharmaceuticals, LLC | 70436-140 | 70436-0140-06 |
| droxidopa | Droxidopa 200 mg/1 | CapsuleOral | Slate Run Pharmaceuticals, LLC | 70436-141 | 70436-0141-06 |
| droxidopa | Droxidopa 300 mg/1 | CapsuleOral | Slate Run Pharmaceuticals, LLC | 70436-142 | 70436-0142-06 |
| Droxidopa | Droxidopa 100 mg/1 | CapsuleOral | Bionpharma Inc. | 69452-256 | 69452-0256-19 |
| Droxidopa | Droxidopa 200 mg/1 | CapsuleOral | Bionpharma Inc. | 69452-257 | 69452-0257-19 |
| Droxidopa | Droxidopa 300 mg/1 | CapsuleOral | Bionpharma Inc. | 69452-258 | 69452-0258-19 |
| Droxidopa | Droxidopa 100 mg/1 | CapsuleOral | Lupin Pharmaceuticals, Inc. | 68180-987 | — |
| Droxidopa | Droxidopa 200 mg/1 | CapsuleOral | Lupin Pharmaceuticals, Inc. | 68180-988 | — |
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 100 mg/1 | CapsuleOral | Ascend Laboratories, LLC | 67877-704 |
| 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 |