NDC codes

FDA NDC Directory
Product NDC (as listed)57664-698Labeler and product segments. Claims need a package NDC.
Product NDC at billing width57664-0698Add 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
57664-698-3657664069836576640698361 TUBE in 1 CARTON (57664-698-36) / 60 g in 1 TUBEMarketed from May 22, 2021

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)
Halcinonide
Generic name (nonproprietary)
halcinonide
Active ingredients
Halcinonide — 1 mg/g
Dosage form
Cream
Route
Topical
Labeler
Sun Pharmaceutical Industries, Inc.NDC labeler code 57664
Product type
Prescription drug
Marketing category
NDA authorized genericApplication NDA 017556
Marketing start
Listing expires
Other FDA classes
Corticosteroid Hormone Receptor Agonists (Mechanism)
Identifiers
Product ID 57664-698_4139dd4b-7346-876e-e063-6394a90a5c1bSPL ID 4139dd4b-7346-876e-e063-6394a90a5c1bSPL set ID aed461bb-e49e-44c4-b42f-b5b261c072a0RxCUI 103467UNII SI86V6QNEGUPC 0357664698365
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 HCPCS code in Med-Code's directory. Topical products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N457664069836 followed by a unit qualifier and the quantity

Package 57664-0698-36. 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)

INDICATIONS AND USAGE Halcinonide cream, USP, 0.1% is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 57664-698

What is NDC 57664-698?
57664-698 is the product NDC for Halcinonide, Halcinonide 1 mg/g cream, listed with the FDA by Sun Pharmaceutical Industries, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Halcinonide.
What is the active ingredient?
Halcinonide.
Who is the labeler?
Sun Pharmaceutical Industries, Inc., NDC labeler code 57664. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Halcinonide?
1 other product NDC are listed under this name. See all Halcinonide 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 Halcinonide NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
HalcinonideHalcinonide 1 mg/gCreamTopicalMylan Pharmaceuticals Inc.0378-805600378-8056-4900378-8056-60

Other NDCs under NDA 017556

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

FDA NDC Directory listings under NDA 017556
ProductStrengthForm · routeLabelerProduct NDC
Haloghalcinonide creamHalcinonide 1 mg/gCreamTopicalSun Pharmaceutical Industries, Inc.10631-094
Haloghalcinonide creamHalcinonide 1 mg/gCreamTopicalGenus Lifesciences Inc.64950-126

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