clobetasol propionate NDC 68382-998

NDC codes

FDA NDC Directory

Product NDC (as listed)68382-998Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68382-0998Add 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
68382-998-01	68382099801	1 BOTTLE in 1 CARTON (68382-998-01) / 59 mL in 1 BOTTLEMarketed from Jul 12, 2017
68382-998-02	68382099802	1 BOTTLE in 1 CARTON (68382-998-02) / 125 mL in 1 BOTTLEMarketed from Jul 12, 2017

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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 — .05 g/mL
Dosage form: Spray
Route: Topical
Labeler: Zydus Pharmaceuticals USA Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 206378
Marketing start: Jul 12, 2017
Listing expires: Dec 31, 2026
Other FDA classes: Corticosteroid Hormone Receptor Agonists (Mechanism)
Identifiers: Product ID 68382-998_4c2a6cc1-353f-4ed0-8a4a-a4d693d3e624SPL ID 4c2a6cc1-353f-4ed0-8a4a-a4d693d3e624SPL set ID 8618a3bc-5601-4273-a708-27b0ecd4c385RxCUI 861512UNII 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

N468382099801 followed by a unit qualifier and the quantity

Package 68382-0998-01. 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 Oct 6, 2022.

Indications (excerpt from the label)

Clobetasol propionate spray, 0.05% is a corticosteroid indicated for the topical treatment of moderate to severe plaque psoriasis affecting up to 20% body surface area (BSA) in patients 18 years of age or older. ( 1.1 ) Limitations of Use: Do not use on the face, axillae or groin. ( 1.2 ) Do not use if atrophy is present at the treatment site. ( 1.2 ) Do not use for rosacea or perioral dermatitis. ( 1.2 ) 1.1 Indication Clobetasol propionate spray, 0.05% is a super-high potent topical corticosteroid formulation indicated for the treatment of moderate to severe plaque psoriasis affecting up to 20% body surface area (BSA) in patients 18 years of age or older. Patients should be instructed to u…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 206378

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

FDA NDC Directory listings under ANDA 206378
Product	Strength	Form · route	Labeler	Product NDC
clobetasol propionate	Clobetasol propionate .05 g/mL	SprayTopical	Zydus Lifesciences Limited	70771-1080