Droxidopa NDC 70710-1391

NDC codes

FDA NDC Directory

Product NDC (as listed)70710-1391Labeler and product segments. Claims need a package NDC.

Product NDC at billing width70710-1391Add 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	Copy
70710-1391-9	70710139109	90 CAPSULE in 1 BOTTLE (70710-1391-9)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 Pharmaceuticals USA Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 211818
Marketing start: Feb 19, 2021
Listing expires: Dec 31, 2026
Other FDA classes: Catecholamines (Chemical structure)Increased Blood Pressure (Physiologic effect)
Identifiers: Product ID 70710-1391_98a2a992-f0a2-47e4-91c0-bdae39b73e63SPL ID 98a2a992-f0a2-47e4-91c0-bdae39b73e63SPL set ID aa3ce55a-1ea9-4b50-b682-6f25398bcc29RxCUI 1490026, 1490034, 1490038UNII J7A92W69L7

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

N470710139109 followed by a unit qualifier and the quantity

Package 70710-1391-09. 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 Sep 18, 2023. 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 blac…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 211818

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

FDA NDC Directory listings under ANDA 211818
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 300 mg/1	CapsuleOral	Zydus Lifesciences Limited	70771-1611
Droxidopa	Droxidopa 100 mg/1	CapsuleOral	Zydus Pharmaceuticals USA Inc.	70710-1389
Droxidopa	Droxidopa 200 mg/1	CapsuleOral	Zydus Pharmaceuticals USA Inc.	70710-1390