What is NDC 42291-321?

42291-321 is the product NDC for Hydroxyurea, Hydroxyurea 500 mg/1 capsule, listed with the FDA by AvKARE. It has 1 package NDC, shown above in 10- and 11-digit form.

AvKARE, NDC labeler code 42291. 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 42291-321 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)42291-321Labeler and product segments. Claims need a package NDC.

Product NDC at billing width42291-0321Add 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
42291-321-01	42291032101	100 CAPSULE in 1 BOTTLE (42291-321-01)Marketed from Jul 23, 2013

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: AvKARENDC labeler code 42291
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 075143
Marketing start: Jul 23, 2013
Listing expires: Dec 31, 2026
Other FDA classes: Urea (Chemical structure)
Identifiers: Product ID 42291-321_4133de1c-b333-3b84-e063-6294a90a2432SPL ID 4133de1c-b333-3b84-e063-6294a90a2432SPL set ID 862583ff-6d5c-3f7d-e3bd-352fb0400928RxCUI 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

N442291032101 followed by a unit qualifier and the quantity

Package 42291-0321-01. 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

Label details couldn’t be retrieved right now. Open the label on DailyMed.

About NDC 42291-321

What is NDC 42291-321?: 42291-321 is the product NDC for Hydroxyurea, Hydroxyurea 500 mg/1 capsule, listed with the FDA by AvKARE. 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?: AvKARE, NDC labeler code 42291. 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	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 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	Teva Pharmaceuticals USA, Inc.	0555-0882