NDC codes

FDA NDC Directory
Product NDC (as listed)0904-6939Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00904-6939Add 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 NDC11-digit (billing)PackageCopy
0904-6939-6100904693961100 BLISTER PACK in 1 CARTON (0904-6939-61) / 1 CAPSULE in 1 BLISTER PACKMarketed from Feb 24, 1999

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
Major PharmaceuticalsNDC labeler code 0904
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 075340
Marketing start
Listing expires
Other FDA classes
Urea (Chemical structure)
Identifiers
Product ID 0904-6939_52e7e651-0f75-47a3-8faa-164416aaae7aSPL ID 52e7e651-0f75-47a3-8faa-164416aaae7aSPL set ID e76fd60e-7644-48c5-9857-3608a045000bRxCUI 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

N400904693961 followed by a unit qualifier and the quantity

Package 00904-6939-61. 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 .

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 0904-6939

What is NDC 0904-6939?
0904-6939 is the product NDC for Hydroxyurea, Hydroxyurea 500 mg/1 capsule, listed with the FDA by Major Pharmaceuticals. 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?
Major Pharmaceuticals, NDC labeler code 0904. 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
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
HydroxyureaHydroxyurea 500 mg/1CapsuleOralCoupler LLC67046-161967046-1619-03
HydroxyureaHydroxyurea 500 mg/1CapsuleOralSomerset Therapeutics, LLC70069-82070069-0820-01
HydroxyureaHydroxyurea 500 mg/1CapsuleOralQilu Pharmaceutical Co., Ltd.67184-060767184-0607-01
HydroxyureaHydroxyurea 500 mg/1CapsuleOralLeading Pharma, LLC69315-16469315-0164-01
HydroxyureaHydroxyurea 500 mg/1CapsuleOralGolden State Medical Supply, Inc.51407-90951407-0909-01
HydroxyureaHydroxyurea 500 mg/1CapsuleOralAvKARE42291-32142291-0321-01
HydroxyureaHydroxyurea 500 mg/1CapsuleOralAmerican Health Packaging68084-28468084-0284-01
HydroxyureaHydroxyurea 500 mg/1CapsuleOralPar Health USA, LLC49884-72449884-0724-01
HydroxyureaHydroxyurea 500 mg/1CapsuleOralTeva Pharmaceuticals USA, Inc.0555-088200555-0882-02

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
ProductStrengthForm · routeLabelerProduct NDC
HydroxyureaHydroxyurea 500 mg/1CapsuleOralPar Health USA, LLC49884-724
HydroxyureaHydroxyurea 500 mg/1CapsuleOralAmerican Health Packaging68084-284

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