What is NDC 0904-7394?

0904-7394 is the product NDC for Droxidopa, Droxidopa 300 mg/1 capsule, listed with the FDA by MAJOR PHARMACEUTICALS. It has 1 package NDC, shown above in 10- and 11-digit form.

MAJOR PHARMACEUTICALS, NDC labeler code 0904. 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.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Droxidopa NDC 0904-7394 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)0904-7394Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00904-7394Add 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
0904-7394-89	0090473948900904739489	90 CAPSULE in 1 BOTTLE (0904-7394-89)Marketed from Dec 28, 2023

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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: MAJOR PHARMACEUTICALSNDC labeler code 0904
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 211741
Marketing start: Feb 19, 2021
Listing expires: Dec 31, 2027
Other FDA classes: Catecholamines (Chemical structure)Increased Blood Pressure (Physiologic effect)
Identifiers: Product ID 0904-7394_cf4934be-a283-4a81-9f26-3148a5e875a8SPL ID cf4934be-a283-4a81-9f26-3148a5e875a8SPL set ID 04b1f69d-ebba-43b9-8ecd-4f6be7c8a0a0RxCUI 1490026, 1490034, 1490038UNII J7A92W69L7UPC 0309047394890, 0309047393893

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

N400904739489 followed by a unit qualifier and the quantity

Package 00904-7394-89. 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 Jan 25, 2024. 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 black…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0904-7394

What is NDC 0904-7394?: 0904-7394 is the product NDC for Droxidopa, Droxidopa 300 mg/1 capsule, listed with the FDA by MAJOR PHARMACEUTICALS. 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?: MAJOR PHARMACEUTICALS, NDC labeler code 0904. 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.

Other finished products listed under the same name: strengths, forms and labelers.

Other Droxidopa NDCs
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 300 mg/1	CapsuleOral	CivicaScript LLC	82249-554	82249-0554-90
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	—

All 42 Droxidopa NDCs

Other NDCs under ANDA 211741

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

FDA NDC Directory listings under ANDA 211741
Product	Strength	Form · route	Labeler	Product NDC
Droxidopa	Droxidopa 100 mg/1	CapsuleOral	MAJOR PHARMACEUTICALS	0904-7392
Droxidopa	Droxidopa 200 mg/1	CapsuleOral	MAJOR PHARMACEUTICALS	0904-7393
Droxidopa	Droxidopa 100 mg/1	CapsuleOral	Novadoz Pharmaceuticals LLC	72205-072
Droxidopa	Droxidopa 200 mg/1	CapsuleOral	Novadoz Pharmaceuticals LLC	72205-073
Droxidopa	Droxidopa 300 mg/1	CapsuleOral	Novadoz Pharmaceuticals LLC	72205-074