NDC codes

FDA NDC Directory
Product NDC (as listed)51407-909Labeler and product segments. Claims need a package NDC.
Product NDC at billing width51407-0909Add 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
51407-909-0151407090901100 CAPSULE in 1 BOTTLE, PLASTIC (51407-909-01)Marketed from Apr 22, 2024

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
Golden State Medical Supply, Inc.NDC labeler code 51407
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 213438
Marketing start
Listing expires
Other FDA classes
Urea (Chemical structure)
Identifiers
Product ID 51407-909_27c291c3-aa28-97af-e063-6394a90a6565SPL ID 27c291c3-aa28-97af-e063-6394a90a6565SPL set ID 1b42f2b4-3880-e7a9-e063-6294a90a5fd0RxCUI 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

N451407090901 followed by a unit qualifier and the quantity

Package 51407-0909-01. 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 .

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 51407-909

What is NDC 51407-909?
51407-909 is the product NDC for Hydroxyurea, Hydroxyurea 500 mg/1 capsule, listed with the FDA by Golden State Medical Supply, 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?
Golden State Medical Supply, Inc., NDC labeler code 51407. 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/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/1CapsuleOralMajor Pharmaceuticals0904-693900904-6939-61
HydroxyureaHydroxyurea 500 mg/1CapsuleOralTeva Pharmaceuticals USA, Inc.0555-088200555-0882-02

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
ProductStrengthForm · routeLabelerProduct NDC
HydroxyureaHydroxyurea 500 mg/1CapsuleOralLeading Pharma, LLC69315-164

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