What is NDC 68308-769?

68308-769 is the product NDC for Halobetasol propionate, Halobetasol propionate .5 mg/g aerosol, foam, listed with the FDA by Mayne Pharma. It has 1 package NDC, shown above in 10- and 11-digit form.

Mayne Pharma, NDC labeler code 68308. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Halobetasol propionate?

13 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Halobetasol propionate NDC 68308-769 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)68308-769Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68308-0769Add 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
68308-769-50	68308076950	1 CANISTER in 1 CARTON (68308-769-50) / 50 g in 1 CANISTERMarketed from Dec 1, 2023

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): Halobetasol propionate
Generic name (nonproprietary): halobetasol propionate
Active ingredients: Halobetasol propionate — .5 mg/g
Dosage form: Aerosol, Foam
Route: Topical
Labeler: Mayne PharmaNDC labeler code 68308
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 215266
Marketing start: Nov 27, 2023
Listing expires: Dec 31, 2026
Other FDA classes: Corticosteroid Hormone Receptor Agonists (Mechanism)
Identifiers: Product ID 68308-769_096144f6-b603-41a6-b2a6-760e3a5c43c5SPL ID 096144f6-b603-41a6-b2a6-760e3a5c43c5SPL set ID 24c41e6d-a314-4984-b45f-e5aa1fffa9b6RxCUI 2047646UNII 91A0K1TY3Z
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

N468308076950 followed by a unit qualifier and the quantity

Package 68308-0769-50. 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 Nov 30, 2023.

Indications (excerpt from the label)

Halobetasol Propionate Topical Foam is indicated for the topical treatment of plaque psoriasis in patients 12 years of age and older. Halobetasol Propionate Topical Foam is a corticosteroid indicated for the topical treatment of plaque psoriasis in patients twelve (12) years of age and older. ( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 68308-769

What is NDC 68308-769?: 68308-769 is the product NDC for Halobetasol propionate, Halobetasol propionate .5 mg/g aerosol, foam, listed with the FDA by Mayne Pharma. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Halobetasol propionate.
What is the active ingredient?: Halobetasol propionate.
Who is the labeler?: Mayne Pharma, NDC labeler code 68308. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Halobetasol propionate?: 13 other product NDCs are listed under this name. See all Halobetasol 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 Halobetasol propionate NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Halobetasol Propionate	Halobetasol propionate .5 mg/g	OintmentTopical	Encube Ethicals, Inc.	21922-108	21922-0108-0421922-0108-14
Halobetasol Propionate	Halobetasol propionate .5 mg/g	LotionTopical	Coral Way Pharma, LLC	85437-008	85437-0008-60
Halobetasol Propionate	Halobetasol propionate .5 mg/g	OintmentTopical	Bryant Ranch Prepack	72162-2067	72162-2067-0272162-2067-04
Halobetasol Propionate	Halobetasol propionate .5 mg/g	OintmentTopical	QUAGEN PHARMACEUTICALS LLC	70752-119	70752-0119-0270752-0119-04
Halobetasol Propionate	Halobetasol propionate .5 mg/g	OintmentTopical	Padagis Israel Pharmaceuticals Ltd	45802-131	45802-0131-3245802-0131-35
Halobetasol Propionate	Halobetasol propionate .5 mg/g	OintmentTopical	Bryant Ranch Prepack	63629-8664	63629-8664-01
Halobetasol Propionate	Halobetasol propionate .5 mg/g	OintmentTopical	Bryant Ranch Prepack	63629-8665	63629-8665-01
Halobetasol Propionate	Halobetasol propionate .5 mg/g	OintmentTopical	Bryant Ranch Prepack	72162-1396	72162-1396-0272162-1396-04
Halobetasol Propionate	Halobetasol propionate .5 mg/g	CreamTopical	Padagis Israel Pharmaceuticals Ltd	45802-129	45802-0129-3245802-0129-35
Halobetasol Propionate	Halobetasol propionate .5 mg/g	CreamTopical	Bryant Ranch Prepack	72162-2331	72162-2331-02

All 14 Halobetasol propionate NDCs

Other NDCs under ANDA 215266

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

FDA NDC Directory listings under ANDA 215266
Product	Strength	Form · route	Labeler	Product NDC
Lexettehalobetasol propionate	Halobetasol propionate .5 mg/g	Aerosol, FoamTopical	Mayne Pharma	51862-618