Prescription drug · ANDA
Halcinonide NDC 0378-8056
Halcinonide 1 mg/g · Cream · Topical · Mylan Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0378-8056-49 | 00378805649 | 1 TUBE in 1 CARTON (0378-8056-49) / 30 g in 1 TUBEMarketed from Aug 15, 2019 | |
| 0378-8056-60 | 00378805660 | 1 TUBE in 1 CARTON (0378-8056-60) / 60 g in 1 TUBEMarketed from Aug 15, 2019 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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
- Mylan Pharmaceuticals Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 211027
- Marketing start
- Listing expires
- Other FDA classes
- Corticosteroid Hormone Receptor Agonists (Mechanism)
- Identifiers
- Product ID 0378-8056_09b49bcc-a3cf-4281-a753-65866b2b8c3bSPL ID 09b49bcc-a3cf-4281-a753-65866b2b8c3bSPL set ID b7d78c72-a683-4208-b7dd-5523502c036cRxCUI 103467UNII 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
N400378805649followed by a unit qualifier and the quantityPackage 00378-8056-49. 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, 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.