Prescription drug · NDA
Halog (Halcinonide cream) NDC 10631-094
Halcinonide 1 mg/g · Cream · Topical · Sun Pharmaceutical Industries, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 10631-094-20 | 1063100942010631009420 | 1 TUBE in 1 CARTON (10631-094-20) / 30 g in 1 TUBEMarketed from Feb 10, 2009 | |
| 10631-094-30 | 1063100943010631009430 | 1 TUBE in 1 CARTON (10631-094-30) / 60 g in 1 TUBEMarketed from Feb 10, 2009 | |
| 10631-094-71 | 1063100947110631009471 | 4 TUBE in 1 CARTON (10631-094-71) / 60 g in 1 TUBEMarketed from Jul 2, 2018 | |
| 10631-094-76 | 1063100947610631009476 | 216 g in 1 JAR (10631-094-76)Marketed from Feb 10, 2009 |
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)
- Halog
- Generic name (nonproprietary)
- halcinonide cream
- Active ingredients
- Halcinonide — 1 mg/g
- Dosage form
- Cream
- Route
- Topical
- Labeler
- Sun Pharmaceutical Industries, Inc.NDC labeler code 10631
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 017556
- Marketing start
- Listing expires
- Other FDA classes
- Corticosteroid Hormone Receptor Agonists (Mechanism)
- Identifiers
- Product ID 10631-094_40cc929a-926f-4de0-871f-6d6395e6e28cSPL ID 40cc929a-926f-4de0-871f-6d6395e6e28cSPL set ID e60d0691-0628-4c98-9a17-f4a89822baf2RxCUI 103467, 206546UNII SI86V6QNEG
- 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
N410631009420followed by a unit qualifier and the quantityPackage 10631-0094-20. 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 HALOG (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 10631-094
- What is NDC 10631-094?
- 10631-094 is the product NDC for Halog (halcinonide cream), Halcinonide 1 mg/g cream, listed with the FDA by Sun Pharmaceutical Industries, Inc.. It has 4 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Halog (Halcinonide Cream).
- What is the active ingredient?
- Halcinonide.
- Who is the labeler?
- Sun Pharmaceutical Industries, Inc., NDC labeler code 10631. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Halog?
- 3 other product NDCs are listed under this name. See all Halog NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Halog products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Haloghalcinonide cream | Halcinonide 1 mg/g | CreamTopical | Genus Lifesciences Inc. | 64950-126 | 64950-0126-06 |
| Haloghalcinonide topical | Halcinonide 1 mg/mL | SolutionTopical | Genus Lifesciences Inc. | 64950-127 | 64950-0127-12 |
| Haloghalcinonide | Halcinonide 1 mg/mL | SolutionTopical | E.R. Squibb & Sons, L.L.C. | 0003-0249 | 00003-0249-1500003-0249-20 |
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 |
|---|---|---|---|---|
| Halcinonide | Halcinonide 1 mg/g | CreamTopical | Sun Pharmaceutical Industries, Inc. | 57664-698 |
| Haloghalcinonide cream | Halcinonide 1 mg/g | CreamTopical | Genus Lifesciences Inc. | 64950-126 |