What is NDC 0168-0163?

0168-0163 is the product NDC for Clobetasol Propionate, Clobetasol propionate .5 mg/g cream, listed with the FDA by E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.. It has 4 package NDCs, shown above in 10- and 11-digit form.

E. Fougera & Co. a division of Fougera Pharmaceuticals Inc., 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 0168-0163

NDC codes

FDA NDC Directory

Product NDC (as listed)0168-0163Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00168-0163Add 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
0168-0163-15	0016801631500168016315	15 g in 1 TUBE (0168-0163-15)Marketed from Sep 30, 1996
0168-0163-30	0016801633000168016330	30 g in 1 TUBE (0168-0163-30)Marketed from Sep 30, 1996
0168-0163-46	0016801634600168016346	45 g in 1 TUBE (0168-0163-46)Marketed from Sep 30, 1996
0168-0163-60	0016801636000168016360	60 g in 1 TUBE (0168-0163-60)Marketed from Sep 30, 1996

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/g
Dosage form: Cream
Route: Topical
Labeler: E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.NDC labeler code 0168
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 074392
Marketing start: Sep 30, 1996
Listing expires: Dec 31, 2026
Other FDA classes: Corticosteroid Hormone Receptor Agonists (Mechanism)
Identifiers: Product ID 0168-0163_42f6771f-30f7-467e-94da-2334ea31fdabSPL ID 42f6771f-30f7-467e-94da-2334ea31fdabSPL set ID 2d4fa3a3-dc1c-4d3c-9959-4751e09d25beRxCUI 861434, 861448, 861495UNII 779619577MUPC 0301680162157, 0301680293158, 0301680163154
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

N400168016315 followed by a unit qualifier and the quantity

Package 00168-0163-15. 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 8, 2025.

Indications (excerpt from the label)

INDICATIONS AND USAGE: Clobetasol propionate gel, cream and ointment are super-high potency corticosteroid formulations indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses. Treatment beyond 2 consecutive weeks is not recommended, and the total dosage should not exceed 50 g per week because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis. Use in pediatric patients under 12 years of age is not recommended. As with other highly active corticosteroids, therapy should be discontinued when control has been achieved. If no improvement is seen within 2 weeks, reassessment of the diagnosis may be nece…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0168-0163

What is NDC 0168-0163?: 0168-0163 is the product NDC for Clobetasol Propionate, Clobetasol propionate .5 mg/g cream, listed with the FDA by E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.. It has 4 package NDCs, 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 Inc., 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

Other NDCs under ANDA 074392

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

FDA NDC Directory listings under ANDA 074392
Product	Strength	Form · route	Labeler	Product NDC
Clobetasol Propionate	Clobetasol propionate .5 mg/g	CreamTopical	Proficient Rx LP	82804-083