NDC codes

FDA NDC Directory
Product NDC (as listed)63323-516Labeler and product segments. Claims need a package NDC.
Product NDC at billing width63323-0516Add 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
63323-516-10633230516106332305161010 VIAL in 1 TRAY (63323-516-10) / 10 mL in 1 VIAL (63323-516-01)Marketed from Apr 5, 2005

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)
Dexamethasone Sodium Phosphate
Generic name (nonproprietary)
dexamethasone sodium phosphate
Active ingredients
Dexamethasone sodium phosphate — 10 mg/mL
Dosage form
Injection, Solution
Route
Intramuscular, Intravenous
Labeler
Fresenius Kabi USA, LLCNDC labeler code 63323
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 040572
Marketing start
Listing expires
Other FDA classes
Corticosteroid Hormone Receptor Agonists (Mechanism)
Identifiers
Product ID 63323-516_2ce90eb7-067d-4f1c-9184-c250e387e533SPL ID 2ce90eb7-067d-4f1c-9184-c250e387e533SPL set ID cca2c160-9188-48e8-9505-49a52388dcb7RxCUI 309696, 1812079UNII AI9376Y64PUPC 0363323506001, 0363323516017, 0363323506032
Pharmacologic class
Corticosteroid

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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.

Administration

Drug administration (CPT 96360–96549)

When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.

How CPT relates to drug billing

NDC on a medical claim

N463323051610 followed by a unit qualifier and the quantity

Package 63323-0516-10. 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 .

Full label on DailyMed (opens in a new tab)

About NDC 63323-516

What is NDC 63323-516?
63323-516 is the product NDC for Dexamethasone Sodium Phosphate, Dexamethasone sodium phosphate 10 mg/mL injection, solution, listed with the FDA by Fresenius Kabi USA, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Dexamethasone Sodium Phosphate.
What is the active ingredient?
Dexamethasone sodium phosphate.
Who is the labeler?
Fresenius Kabi USA, LLC, NDC labeler code 63323. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Dexamethasone Sodium Phosphate?
94 other product NDCs are listed under this name. See all Dexamethasone Sodium Phosphate 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 Dexamethasone Sodium Phosphate NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Dexamethasone Sodium PhosphateDexamethasone sodium phosphate 4 mg/mLInjection, SolutionIntra-articular, Intralesional, Intramuscular, Intravenous, Soft tissueREMEDYREPACK INC.70518-437270518-4372-00
Dexamethasone Sodium PhosphateDexamethasone sodium phosphate 10 mg/mLInjection, SolutionIntramuscular, IntravenousArmas Pharmaceuticals72485-11872485-0118-25
Dexamethasone Sodium PhosphateDexamethasone sodium phosphate 4 mg/mLInjection, SolutionIntra-articular, Intralesional, Intramuscular, Intravenous, Soft tissueHenry Schein, Inc.0404-979500404-9795-30
Dexamethasone Sodium PhosphateDexamethasone sodium phosphate 4 mg/mLInjectionIntra-articular, Intralesional, Intramuscular, Intravenous, Soft tissueHenry Schein, Inc.0404-980500404-9805-05
Dexamethasone Sodium PhosphateDexamethasone sodium phosphate 4 mg/mLInjection, SolutionIntra-articular, Intralesional, Intramuscular, Intravenous, Soft tissueMedical Purchasing Solutions, LLC.71872-734771872-7347-01
Dexamethasone Sodium PhosphateDexamethasone sodium phosphate 4 mg/mLInjection, SolutionIntra-articular, Intralesional, Intramuscular, Intravenous, Soft tissueSagent Pharmaceuticals25021-05225021-0052-0125021-0052-05
Dexamethasone Sodium PhosphateDexamethasone sodium phosphate 10 mg/mLInjection, SolutionIntra-articular, Intralesional, Intramuscular, Intravenous, Soft tissueSagent Pharmaceuticals25021-05325021-0053-01
Dexamethasone sodium phosphateDexamethasone sodium phosphate 10 mg/mLInjection, SolutionIntramuscular, IntravenousMicro Labs Limited42571-43242571-0432-4042571-0432-79
Dexamethasone Sodium PhosphateDexamethasone sodium phosphate 10 mg/mLInjection, EmulsionIntramuscular, IntravenousFresenius Kabi USA, LLC76045-21276045-0212-10
Dexamethasone Sodium PhosphateDexamethasone sodium phosphate 10 mg/mLInjectionIntra-articular, Intralesional, Intramuscular, Intravenous, Soft tissueGland Pharma Limited68083-60768083-0607-25

All 95 Dexamethasone Sodium Phosphate NDCs

Other NDCs under ANDA 040572

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

FDA NDC Directory listings under ANDA 040572
ProductStrengthForm · routeLabelerProduct NDC
Dexamethasone Sodium PhosphateDexamethasone sodium phosphate 10 mg/mLInjection, SolutionIntramuscular, IntravenousHF Acquisition Co LLC, DBA HealthFirst51662-1391

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