What is NDC 0168-0269?

0168-0269 is the product NDC for Clobetasol Propionate, Clobetasol propionate .5 mg/mL solution, listed with the FDA by E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.

E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC, NDC labeler code 0168. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Clobetasol Propionate?

96 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Clobetasol Propionate NDC 0168-0269

NDC codes

FDA NDC Directory

Product NDC (as listed)0168-0269Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00168-0269Add 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	Copy
0168-0269-50	0016802695000168026950	50 mL in 1 BOTTLE, PLASTIC (0168-0269-50)Marketed from Feb 8, 1999

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): Clobetasol Propionate
Generic name (nonproprietary): clobetasol propionate
Active ingredients: Clobetasol propionate — .5 mg/mL
Dosage form: Solution
Route: Topical
Labeler: E. Fougera & Co. a division of Fougera Pharmaceuticals, LLCNDC labeler code 0168
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 075391
Marketing start: Feb 8, 1999
Listing expires: Dec 31, 2027
Other FDA classes: Corticosteroid Hormone Receptor Agonists (Mechanism)
Identifiers: Product ID 0168-0269_3ae739b7-7eaa-4dbd-a696-a3a0e3998f38SPL ID 3ae739b7-7eaa-4dbd-a696-a3a0e3998f38SPL set ID 736325f3-a369-4d70-b608-3d6ba37b6a6bRxCUI 861487UNII 779619577M
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

N400168026950 followed by a unit qualifier and the quantity

Package 00168-0269-50. 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 Jan 28, 2026.

Indications (excerpt from the label)

INDICATIONS AND USAGE: Clobetasol propionate topical solution USP, 0.05% is indicated for short-term topical treatment of inflammatory and pruritic manifestations of moderate to severe corticosteroid-responsive dermatoses of the scalp. Treatment beyond 2 consecutive weeks is not recommended, and the total dosage should not exceed 50 mL/week because of the potential for the drug to suppress the HPA axis. This product is not recommended for use in pediatric patients under 12 years of age.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0168-0269

What is NDC 0168-0269?: 0168-0269 is the product NDC for Clobetasol Propionate, Clobetasol propionate .5 mg/mL solution, listed with the FDA by E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Clobetasol Propionate.
What is the active ingredient?: Clobetasol propionate.
Who is the labeler?: E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC, NDC labeler code 0168. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Clobetasol Propionate?: 96 other product NDCs are listed under this name. See all Clobetasol Propionate 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 Clobetasol Propionate NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Clobetasol Propionate	Clobetasol propionate .5 mg/g	OintmentTopical	A-S Medication Solutions	50090-8001	50090-8001-00
Clobetasol Propionate	Clobetasol propionate .5 mg/g	OintmentTopical	NorthStar RxLLC	72603-855	72603-0855-0172603-0855-0272603-0855-03+1 more
Clobetasol Propionate	Clobetasol propionate .5 mg/g	Aerosol, FoamTopical	Alembic Pharmaceuticals Limited	46708-707	46708-0707-3146708-0707-50
Clobetasol Propionate	Clobetasol propionate .5 mg/g	CreamTopical	Alembic Pharmaceuticals Limited	46708-547	46708-0547-1546708-0547-3046708-0547-45+1 more
Clobetasol Propionate	Clobetasol propionate .05 g/100mL	ShampooTopical	Alembic Pharmaceuticals Limited	46708-548	46708-0548-04
Clobetasol Propionate	Clobetasol propionate .5 mg/mL	SolutionTopical	Alembic Pharmaceuticals Limited	46708-486	46708-0486-2546708-0486-50
Clobetasol Propionate	Clobetasol propionate .05 g/mL	SprayTopical	Alembic Pharmaceuticals Limited	46708-425	46708-0425-1246708-0425-59
Clobetasol Propionate	Clobetasol propionate .5 mg/g	OintmentTopical	Alembic Pharmaceuticals Limited	46708-465	46708-0465-1546708-0465-3046708-0465-45+1 more
Clobetasol Propionate	Clobetasol propionate .25 mg/g	CreamTopical	INA Pharmaceutics Inc	74157-710	74157-0710-10
Clobetasol Propionate	Clobetasol propionate .5 mg/g	CreamTopical	Torrent Pharmaceuticals Limited	13668-569	13668-0569-0113668-0569-0213668-0569-04+1 more

All 97 Clobetasol Propionate NDCs