Hydroxyurea NDC 68084-284

NDC codes

FDA NDC Directory

Product NDC (as listed)68084-284Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68084-0284Add 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
68084-284-01	68084028401	100 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-284-01) / 1 CAPSULE in 1 BLISTER PACK (68084-284-11)Marketed from Sep 17, 2008

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): Hydroxyurea
Generic name (nonproprietary): hydroxyurea
Active ingredients: Hydroxyurea — 500 mg/1
Dosage form: Capsule
Route: Oral
Labeler: American Health Packaging
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 075340
Marketing start: Sep 17, 2008
Listing expires: Dec 31, 2027
Other FDA classes: Urea (Chemical structure)
Identifiers: Product ID 68084-284_4c118bb8-d003-3029-e063-6394a90a7d36SPL ID 4c118bb8-d003-3029-e063-6394a90a7d36SPL set ID c84a2241-6c05-480f-8a5b-049e08c27d73RxCUI 197797UNII X6Q56QN5QC
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

N468084028401 followed by a unit qualifier and the quantity

Package 68084-0284-01. 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 Mar 2, 2026.

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)

Other NDCs under ANDA 075340

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

FDA NDC Directory listings under ANDA 075340
Product	Strength	Form · route	Labeler	Product NDC
Hydroxyurea	Hydroxyurea 500 mg/1	CapsuleOral	Par Health USA, LLC	49884-724
Hydroxyurea	Hydroxyurea 500 mg/1	CapsuleOral	Major Pharmaceuticals	0904-6939