What is NDC 67184-0607?

67184-0607 is the product NDC for Hydroxyurea, Hydroxyurea 500 mg/1 capsule, listed with the FDA by Qilu Pharmaceutical Co., Ltd.. It has 1 package NDC, shown above in 10- and 11-digit form.

Qilu Pharmaceutical Co., Ltd., NDC labeler code 67184. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Hydroxyurea?

9 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Hydroxyurea NDC 67184-0607 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)67184-0607Labeler and product segments. Claims need a package NDC.

Product NDC at billing width67184-0607Add 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
67184-0607-1	6718406070167184060701	100 CAPSULE in 1 BOTTLE (67184-0607-1)Marketed from Mar 6, 2024

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): Hydroxyurea
Generic name (nonproprietary): hydroxyurea
Active ingredients: Hydroxyurea — 500 mg/1
Dosage form: Capsule
Route: Oral
Labeler: Qilu Pharmaceutical Co., Ltd.NDC labeler code 67184
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 218021
Marketing start: Mar 6, 2024
Listing expires: Dec 31, 2026
Other FDA classes: Urea (Chemical structure)
Identifiers: Product ID 67184-0607_a252a0db-b5ce-49d2-b29d-461b34a41479SPL ID a252a0db-b5ce-49d2-b29d-461b34a41479SPL set ID 4cd244d4-bd4a-41c8-b072-c2135787d412RxCUI 197797UNII X6Q56QN5QCUPC 0367184060719
Pharmacologic class: Antimetabolite

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

N467184060701 followed by a unit qualifier and the quantity

Package 67184-0607-01. 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 Apr 30, 2024.

Indications (excerpt from the label)

Hydroxyurea capsules are indicated for the treatment of: • Resistant chronic myeloid leukemia. • Locally advanced squamous cell carcinomas of the head and neck (excluding the lip) in combination with chemoradiation. Hydroxyurea capsules are an antimetabolite indicated for the treatment of: Resistant chronic myeloid leukemia. (1) Locally advanced squamous cell carcinomas of the head and neck, (excluding lip) in combination with concurrent chemoradiation. (1)

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 67184-0607

What is NDC 67184-0607?: 67184-0607 is the product NDC for Hydroxyurea, Hydroxyurea 500 mg/1 capsule, listed with the FDA by Qilu Pharmaceutical Co., Ltd.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Hydroxyurea.
What is the active ingredient?: Hydroxyurea.
Who is the labeler?: Qilu Pharmaceutical Co., Ltd., NDC labeler code 67184. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Hydroxyurea?: 9 other product NDCs are listed under this name. See all Hydroxyurea 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 Hydroxyurea NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Hydroxyurea	Hydroxyurea 500 mg/1	CapsuleOral	Coupler LLC	67046-1619	67046-1619-03
Hydroxyurea	Hydroxyurea 500 mg/1	CapsuleOral	Somerset Therapeutics, LLC	70069-820	70069-0820-01
Hydroxyurea	Hydroxyurea 500 mg/1	CapsuleOral	Leading Pharma, LLC	69315-164	69315-0164-01
Hydroxyurea	Hydroxyurea 500 mg/1	CapsuleOral	Golden State Medical Supply, Inc.	51407-909	51407-0909-01
Hydroxyurea	Hydroxyurea 500 mg/1	CapsuleOral	AvKARE	42291-321	42291-0321-01
Hydroxyurea	Hydroxyurea 500 mg/1	CapsuleOral	American Health Packaging	68084-284	68084-0284-01
Hydroxyurea	Hydroxyurea 500 mg/1	CapsuleOral	Major Pharmaceuticals	0904-6939	00904-6939-61
Hydroxyurea	Hydroxyurea 500 mg/1	CapsuleOral	Par Health USA, LLC	49884-724	49884-0724-01
Hydroxyurea	Hydroxyurea 500 mg/1	CapsuleOral	Teva Pharmaceuticals USA, Inc.	0555-0882	00555-0882-02

Other NDCs under ANDA 218021

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

FDA NDC Directory listings under ANDA 218021
Product	Strength	Form · route	Labeler	Product NDC
Hydroxyurea	Hydroxyurea 500 mg/1	CapsuleOral	Coupler LLC	67046-1619
Hydroxyurea	Hydroxyurea 500 mg/1	CapsuleOral	Somerset Therapeutics, LLC	70069-820