Prescription drug · ANDA
Kourzeq (Triamcinolone acetonide) NDC 82682-001
Triamcinolone acetonide 1 mg/g · Paste · Topical · MidAmerica Pharmaceuticals
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 82682-001-05 | 82682000105 | 1 TUBE in 1 CARTON (82682-001-05) / 5 g in 1 TUBEMarketed from Sep 15, 2023 |
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)
- Kourzeq
- Generic name (nonproprietary)
- triamcinolone acetonide
- Active ingredients
- Triamcinolone acetonide — 1 mg/g
- Dosage form
- Paste
- Route
- Topical
- Labeler
- MidAmerica PharmaceuticalsNDC labeler code 82682
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 040771
- Marketing start
- Listing expires
- Other FDA classes
- Corticosteroid Hormone Receptor Agonists (Mechanism)
- Identifiers
- Product ID 82682-001_7aad2f23-85cb-4228-8460-aef6676cc11fSPL ID 7aad2f23-85cb-4228-8460-aef6676cc11fSPL set ID aad48d1e-f8db-4020-92af-0b3258bbc0f2RxCUI 1085728, 2665617UNII F446C597KA
- 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
N482682000105followed by a unit qualifier and the quantityPackage 82682-0001-05. 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 KOURZEQ is indicated for adjunctive treatment and for the temporary relief of symptoms associated with oral inflammatory lesions and ulcerative lesions resulting from trauma.
Excerpt only. Read the full label for complete information.
About NDC 82682-001
- What is NDC 82682-001?
- 82682-001 is the product NDC for Kourzeq (triamcinolone acetonide), Triamcinolone acetonide 1 mg/g paste, listed with the FDA by MidAmerica Pharmaceuticals. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Kourzeq (Triamcinolone Acetonide).
- What is the active ingredient?
- Triamcinolone acetonide.
- Who is the labeler?
- MidAmerica Pharmaceuticals, NDC labeler code 82682. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Kourzeq?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Other NDCs under ANDA 040771
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 |
|---|---|---|---|---|
| Triamcinolone Acetonide | Triamcinolone acetonide 1 mg/g | PasteTopical | Preferred Pharmaceuticals, Inc. | 68788-8386 |
| Triamcinolone Acetonide | Triamcinolone acetonide 1 mg/g | PasteTopical | Rising Pharma Holdings, Inc. | 64980-320 |