NDC codes

FDA NDC Directory
Product NDC (as listed)0168-0332Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00168-0332Add 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 NDC11-digit (billing)PackageCopy
0168-0332-150016803321515 g in 1 TUBE (0168-0332-15)Marketed from May 14, 2004
0168-0332-300016803323030 g in 1 TUBE (0168-0332-30)Marketed from May 14, 2004
0168-0332-600016803326060 g in 1 TUBE (0168-0332-60)Marketed from May 14, 2004

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)
Fluticasone Propionate
Generic name (nonproprietary)
fluticasone propionate
Active ingredients
Fluticasone propionate — .5 mg/g
Dosage form
Cream
Route
Topical
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 076451
Marketing start
Listing expires
Other FDA classes
Corticosteroid Hormone Receptor Agonists (Mechanism)
Identifiers
Product ID 0168-0332_c1a3e651-d30b-49d5-8c5b-77a07006194fSPL ID c1a3e651-d30b-49d5-8c5b-77a07006194fSPL set ID 0e20d1cc-5c7a-4e0d-810b-b94c4d6dd1c0RxCUI 895987UNII O2GMZ0LF5WUPC 0301680332154
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

N400168033215 followed by a unit qualifier and the quantity

Package 00168-0332-15. 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 .

Indications (excerpt from the label)

INDICATIONS AND USAGE Fluticasone propionate cream, 0.05% is a medium potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Fluticasone propionate cream, 0.05% may be used with caution in pediatric patients 3 months of age or older. The safety and efficacy of drug use for longer than 4 weeks in this population have not been established. The safety and efficacy of fluticasone propionate cream, 0.05% in pediatric patients below 3 months of age have not been established.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 076451

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 076451
ProductStrengthForm · routeLabelerProduct NDC
Fluticasone PropionateFluticasone propionate .5 mg/gCreamTopicalProficient Rx LP63187-959

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