Prescription drug · NDA AUTHORIZED GENERIC
Halcinonide NDC 57664-698
Halcinonide 1 mg/g · Cream · Topical · Sun Pharmaceutical Industries, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 57664-698-36 | 5766406983657664069836 | 1 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
N457664069836followed by a unit qualifier and the quantityPackage 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.
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.
Related NDCs: other Halcinonide products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Halcinonide | Halcinonide 1 mg/g | CreamTopical | Mylan Pharmaceuticals Inc. | 0378-8056 | 00378-8056-4900378-8056-60 |
Other NDCs under NDA 017556
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Haloghalcinonide cream | Halcinonide 1 mg/g | CreamTopical | Sun Pharmaceutical Industries, Inc. | 10631-094 |
| Haloghalcinonide cream | Halcinonide 1 mg/g | CreamTopical | Genus Lifesciences Inc. | 64950-126 |