Droxidopa NDC 50228-429

NDC codes

FDA NDC Directory

Product NDC (as listed)50228-429Labeler and product segments. Claims need a package NDC.

Product NDC at billing width50228-0429Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package
50228-429-10	50228042910	1000 CAPSULE in 1 BOTTLE (50228-429-10)Marketed from Feb 18, 2021
50228-429-30	50228042930	30 CAPSULE in 1 BOTTLE (50228-429-30)Marketed from Feb 18, 2021
50228-429-90	50228042990	90 CAPSULE in 1 BOTTLE (50228-429-90)Marketed from Feb 18, 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: ScieGen Pharmaceuticals Inc
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 214017
Marketing start: Feb 18, 2021
Listing expires: Dec 31, 2026
Other FDA classes: Catecholamines (Chemical structure)Increased Blood Pressure (Physiologic effect)
Identifiers: Product ID 50228-429_bbb2d8e3-70b5-78f2-e053-2995a90a285eSPL ID bbb2d8e3-70b5-78f2-e053-2995a90a285eSPL set ID 10b02d98-ebb8-4152-bd56-3402417fbf79RxCUI 1490026, 1490034, 1490038UNII J7A92W69L7UPC 0350228429306, 0350228429900, 0350228431309, 0350228431903, 0350228430302, 0350228430906

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

N450228042910 followed by a unit qualifier and the quantity

Package 50228-0429-10. 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 Feb 19, 2021. 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.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 214017

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 214017
Product	Strength	Form · route	Labeler	Product NDC
Droxidopa	Droxidopa 100 mg/1	CapsuleOral	Golden State Medical Supply, Inc.	51407-765
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 300 mg/1	CapsuleOral	ScieGen Pharmaceuticals Inc	50228-431