Alclometasone Dipropionate NDC 0168-0263

NDC codes

FDA NDC Directory

Product NDC (as listed)0168-0263Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00168-0263Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package
0168-0263-15	00168026315	15 g in 1 TUBE (0168-0263-15)Marketed from Jul 12, 2005
0168-0263-45	00168026345	45 g in 1 TUBE (0168-0263-45)Marketed from Jul 12, 2005
0168-0263-60	00168026360	60 g in 1 TUBE (0168-0263-60)Marketed from Jul 12, 2005

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): Alclometasone Dipropionate
Generic name (nonproprietary): alclometasone dipropionate
Active ingredients: Alclometasone dipropionate — .5 mg/g
Dosage form: Cream
Route: Topical
Labeler: E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 076973
Marketing start: Jul 12, 2005
Listing expires: Dec 31, 2026
Other FDA classes: Corticosteroid Hormone Receptor Agonists (Mechanism)
Identifiers: Product ID 0168-0263_901e10b7-2784-49c4-8e56-1c461aaad927SPL ID 901e10b7-2784-49c4-8e56-1c461aaad927SPL set ID 6aacce3f-aa2f-4f2c-a5bd-8cff157a3dabRxCUI 855474UNII S56PQL4N1VUPC 0301680263151
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

N400168026315 followed by a unit qualifier and the quantity

Package 00168-0263-15. 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 Jul 9, 2025.

Indications (excerpt from the label)

INDICATIONS AND USAGE: Alclometasone dipropionate cream is a low to medium potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Alclometasone dipropionate cream 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 have not been established in pediatric patients below 1 year of age, the use in this age-group is not recommended.

Excerpt only. Read the full label for complete information.

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