What is NDC 70954-824?

70954-824 is the product NDC for Hydroxyurea, Hydroxyurea 1000 mg/1 tablet, film coated, listed with the FDA by ANI Pharmaceuticals, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

ANI Pharmaceuticals, Inc., NDC labeler code 70954. 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 70954-824 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)70954-824Labeler and product segments. Claims need a package NDC.

Product NDC at billing width70954-0824Add 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
70954-824-10	7095408241070954082410	30 TABLET, FILM COATED in 1 BOTTLE (70954-824-10)Marketed from Nov 10, 2026

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 — 1000 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: ANI Pharmaceuticals, Inc.NDC labeler code 70954
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 220300
Marketing start: Nov 10, 2026
Listing expires: Dec 31, 2027
Other FDA classes: Urea (Chemical structure)
Identifiers: Product ID 70954-824_f7b8cae7-7f38-4c17-a9e2-fc123c102e0cSPL ID f7b8cae7-7f38-4c17-a9e2-fc123c102e0cSPL set ID f7b8cae7-7f38-4c17-a9e2-fc123c102e0cUNII 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

N470954082410 followed by a unit qualifier and the quantity

Package 70954-0824-10. 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 Nov 4, 2026. This label includes a boxed warning.

Indications (excerpt from the label)

Hydroxyurea tablets are indicated to reduce the frequency of painful crises and to reduce the need for blood transfusions in adult and pediatric patients, 2 years of age and older, with sickle cell anemia with recurrent moderate to severe painful crises. Hydroxyurea tablets is an antimetabolite, indicated to reduce the frequency of painful crises and to reduce the need for blood transfusions in adult and pediatric patients, 2 years of age and older, with sickle cell anemia with recurrent moderate to severe painful crises. (1)

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 70954-824

What is NDC 70954-824?: 70954-824 is the product NDC for Hydroxyurea, Hydroxyurea 1000 mg/1 tablet, film coated, listed with the FDA by ANI Pharmaceuticals, 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?: ANI Pharmaceuticals, Inc., NDC labeler code 70954. 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
Hydroxyurea	Hydroxyurea 500 mg/1	CapsuleOral	Teva Pharmaceuticals USA, Inc.	0555-0882	00555-0882-02

Other NDCs under ANDA 220300

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

FDA NDC Directory listings under ANDA 220300
Product	Strength	Form · route	Labeler	Product NDC
Hydroxyurea	Hydroxyurea 100 mg/1	Tablet, Film coatedOral	ANI Pharmaceuticals, Inc.	70954-823