NDC codes

FDA NDC Directory
Product NDC (as listed)68788-8593Labeler and product segments. Claims need a package NDC.
Product NDC at billing width68788-8593Add 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
68788-8593-3687888593036878885930330 g in 1 TUBE (68788-8593-3)Marketed from Feb 23, 2024
68788-8593-668788859306687888593061 TUBE in 1 CARTON (68788-8593-6) / 60 g in 1 TUBEMarketed from Feb 23, 2024

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)
Fluocinonide
Generic name (nonproprietary)
fluocinonide
Active ingredients
Fluocinonide — .5 mg/g
Dosage form
Cream
Route
Topical
Labeler
Preferred Pharmaceuticals Inc.NDC labeler code 68788
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 073085
Marketing start
Listing expires
Other FDA classes
Corticosteroid Hormone Receptor Agonists (Mechanism)
Identifiers
Product ID 68788-8593_4b1dd24d-5bd8-4262-87af-6635fe79a7cdSPL ID 4b1dd24d-5bd8-4262-87af-6635fe79a7cd
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

N468788859303 followed by a unit qualifier and the quantity

Package 68788-8593-03. 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

The FDA listing for this product does not reference a label (SPL) set.

About NDC 68788-8593

What is NDC 68788-8593?
68788-8593 is the product NDC for Fluocinonide, Fluocinonide .5 mg/g cream, listed with the FDA by Preferred Pharmaceuticals Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Fluocinonide.
What is the active ingredient?
Fluocinonide.
Who is the labeler?
Preferred Pharmaceuticals Inc., NDC labeler code 68788. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Fluocinonide?
50 other product NDCs are listed under this name. See all Fluocinonide NDCs.
Is there a related HCPCS / J-code?
Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Fluocinonide NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
FluocinonideFluocinonide .5 mg/mLSolutionTopicalSaptalis Pharmaceuticals, LLC.71656-09471656-0094-2071656-0094-60
FluocinonideFluocinonide .5 mg/mLSolutionTopicalNorthStar RxLLC72603-70372603-0703-01
FluocinonideFluocinonide .5 mg/mLSolutionTopicalBryant Ranch Prepack72162-249072162-2490-0272162-2490-06
FluocinonideFluocinonide .5 mg/gGelTopicalPadagis Israel Pharmaceuticals Ltd45802-76145802-0761-1545802-0761-3045802-0761-60
FluocinonideFluocinonide .5 mg/mLSolutionTopicalQUAGEN PHARMACEUTICALS LLC70752-15470752-0154-05
FluocinonideFluocinonide .5 mg/gCreamTopicalEncube Ethicals, Inc.21922-06421922-0064-0321922-0064-0421922-0064-05+1 more
FluocinonideFluocinonide .5 mg/gOintmentTopicalPreferred Pharmaceuticals Inc.68788-855468788-8554-06
FluocinonideFluocinonide .5 mg/gCreamTopicalCosette Pharmaceuticals, Inc.0713-066300713-0663-1500713-0663-3100713-0663-60
FluocinonideFluocinonide 1 mg/gCreamTopicalViona Pharmaceuticals Inc72578-08772578-0087-0272578-0087-0672578-0087-07
FluocinonideFluocinonide 1 mg/gCreamTopicalZydus Lifesciences Limited70771-139370771-1393-0270771-1393-0370771-1393-05

All 51 Fluocinonide NDCs

Other NDCs under ANDA 073085

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

FDA NDC Directory listings under ANDA 073085
ProductStrengthForm · routeLabelerProduct NDC
FluocinonideFluocinonide .5 mg/gCreamTopicalCosette Pharmaceuticals, Inc.0713-0663

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