What is NDC 0555-0882?

0555-0882 is the product NDC for Hydroxyurea, Hydroxyurea 500 mg/1 capsule, listed with the FDA by Teva Pharmaceuticals USA, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

Teva Pharmaceuticals USA, Inc., NDC labeler code 0555. 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 0555-0882 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)0555-0882Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00555-0882Add 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
0555-0882-02	00555088202	100 CAPSULE in 1 BOTTLE (0555-0882-02)Marketed from Oct 19, 1998

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): Hydroxyurea
Generic name (nonproprietary): hydroxyurea
Active ingredients: Hydroxyurea — 500 mg/1
Dosage form: Capsule
Route: Oral
Labeler: Teva Pharmaceuticals USA, Inc.NDC labeler code 0555
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 075143
Marketing start: Oct 19, 1998
Listing expires: Dec 31, 2026
Other FDA classes: Urea (Chemical structure)
Identifiers: Product ID 0555-0882_9d7feae3-66af-434e-b5dc-569e8ce56b80SPL ID 9d7feae3-66af-434e-b5dc-569e8ce56b80SPL set ID b9514ae5-79ae-4cc2-9d7f-c8f7806d1694RxCUI 197797UNII X6Q56QN5QCUPC 0305550882022
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

N400555088202 followed by a unit qualifier and the quantity

Package 00555-0882-02. 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 May 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 0555-0882

What is NDC 0555-0882?: 0555-0882 is the product NDC for Hydroxyurea, Hydroxyurea 500 mg/1 capsule, listed with the FDA by Teva Pharmaceuticals USA, Inc.. 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?: Teva Pharmaceuticals USA, Inc., NDC labeler code 0555. 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	Qilu Pharmaceutical Co., Ltd.	67184-0607	67184-0607-01
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

Other NDCs under ANDA 075143

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

FDA NDC Directory listings under ANDA 075143
Product	Strength	Form · route	Labeler	Product NDC
Hydroxyurea	Hydroxyurea 500 mg/1	CapsuleOral	AvKARE	42291-321