Prescription drug · ANDA
Alclometasone Dipropionate NDC 68462-299
Alclometasone dipropionate .5 mg/g · Ointment · Topical · Glenmark Pharmaceuticals Inc., USA
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68462-299-17 | 68462029917 | 15 g in 1 TUBE (68462-299-17)Marketed from Jul 30, 2009 | |
| 68462-299-47 | 68462029947 | 45 g in 1 TUBE (68462-299-47)Marketed from Jul 30, 2009 | |
| 68462-299-65 | 68462029965 | 60 g in 1 TUBE (68462-299-65)Marketed from Jul 30, 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)
- Alclometasone Dipropionate
- Generic name (nonproprietary)
- alclometasone dipropionate
- Active ingredients
- Alclometasone dipropionate — .5 mg/g
- Dosage form
- Ointment
- Route
- Topical
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 079227
- Marketing start
- Listing expires
- Other FDA classes
- Corticosteroid Hormone Receptor Agonists (Mechanism)
- Identifiers
- Product ID 68462-299_098145f1-cb92-4222-8069-72fbf92fce9fSPL ID 098145f1-cb92-4222-8069-72fbf92fce9fSPL set ID 63e635e0-65d8-4b30-9f2a-ab16deba90bdRxCUI 855474, 855480UNII S56PQL4N1V
- 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
N468462029917followed by a unit qualifier and the quantityPackage 68462-0299-17. 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 Alclometasone dipropionate cream and ointment are low to medium potency corticosteroids indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Alclometasone dipropionate cream and ointment may be used in pediatric patients 1 year of age or older, although the safety and efficacy of drug use for longer than 3 weeks have not been established (see PRECAUTIONS: Pediatric Use ). Since the safety and efficacy of alclometasone dipropionate cream and ointment have not been established in pediatric patients below 1 year of age, their use in this age-group is not recommended.
Excerpt only. Read the full label for complete information.