Prescription drug · ANDA
Alclometasone Dipropionate NDC 51672-1316
Alclometasone dipropionate .5 mg/g · Ointment · Topical · Sun Pharmaceutical Industries, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 51672-1316-1 | 51672131601 | 1 TUBE in 1 CARTON (51672-1316-1) / 15 g in 1 TUBEMarketed from Jul 29, 2004 | |
| 51672-1316-3 | 51672131603 | 1 TUBE in 1 CARTON (51672-1316-3) / 60 g in 1 TUBEMarketed from Jul 29, 2004 | |
| 51672-1316-5 | 51672131605 | 5 g in 1 TUBE (51672-1316-5)Marketed from Jul 29, 2004 | |
| 51672-1316-6 | 51672131606 | 1 TUBE in 1 CARTON (51672-1316-6) / 45 g in 1 TUBEMarketed from Jul 29, 2004 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 076730
- Marketing start
- Listing expires
- Other FDA classes
- Corticosteroid Hormone Receptor Agonists (Mechanism)
- Identifiers
- Product ID 51672-1316_3c44a51b-8abe-ceae-e063-6294a90a482cSPL ID 3c44a51b-8abe-ceae-e063-6294a90a482cSPL set ID 3b0dccd6-dee1-49dd-8c6d-82df5c7ee36cRxCUI 855480UNII S56PQL4N1VUPC 0351672131630, 0351672131616
- 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
N451672131601followed by a unit qualifier and the quantityPackage 51672-1316-01. 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 Ointment USP, 0.05% is a low to medium potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Alclometasone dipropionate 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 ointment has 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.