What is NDC 69315-164?

69315-164 is the product NDC for Hydroxyurea, Hydroxyurea 500 mg/1 capsule, listed with the FDA by Leading Pharma, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.

Leading Pharma, LLC, NDC labeler code 69315. 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 69315-164 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)69315-164Labeler and product segments. Claims need a package NDC.

Product NDC at billing width69315-0164Add 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
69315-164-01	69315016401	100 CAPSULE in 1 BOTTLE, PLASTIC (69315-164-01)Marketed from Jul 9, 2020

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: Leading Pharma, LLCNDC labeler code 69315
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 213438
Marketing start: Jul 9, 2020
Listing expires: Dec 31, 2026
Other FDA classes: Urea (Chemical structure)
Identifiers: Product ID 69315-164_3706a800-8ea5-4593-9c7b-5083978b559bSPL ID 3706a800-8ea5-4593-9c7b-5083978b559bSPL set ID 4c4e1c2f-2143-44f3-8825-aeba42e755e4RxCUI 197797UNII X6Q56QN5QCUPC 0369315164013
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

N469315016401 followed by a unit qualifier and the quantity

Package 69315-0164-01. 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 Oct 29, 2024.

Indications (excerpt from the label)

Hydroxyurea capsules, USP is 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, USP is 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 69315-164

What is NDC 69315-164?: 69315-164 is the product NDC for Hydroxyurea, Hydroxyurea 500 mg/1 capsule, listed with the FDA by Leading Pharma, LLC. 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?: Leading Pharma, LLC, NDC labeler code 69315. 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	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	Par Health USA, LLC	49884-724	49884-0724-01
Hydroxyurea	Hydroxyurea 500 mg/1	CapsuleOral	Major Pharmaceuticals	0904-6939	00904-6939-61
Hydroxyurea	Hydroxyurea 500 mg/1	CapsuleOral	Teva Pharmaceuticals USA, Inc.	0555-0882	00555-0882-02

Other NDCs under ANDA 213438

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

FDA NDC Directory listings under ANDA 213438
Product	Strength	Form · route	Labeler	Product NDC
Hydroxyurea	Hydroxyurea 500 mg/1	CapsuleOral	Golden State Medical Supply, Inc.	51407-909