What is NDC 33342-506?

33342-506 is the product NDC for Clobetasol Propionate ANDA (clobetasol propionate), Clobetasol propionate .5 mg/g ointment, listed with the FDA by Macleods Pharmaceuticals Limited. It has 4 package NDCs, shown above in 10- and 11-digit form.

What drug is associated with this NDC?

Clobetasol Propionate ANDA (Clobetasol Propionate).

Macleods Pharmaceuticals Limited, NDC labeler code 33342. 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 ANDA?

None: this is the only finished product listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Clobetasol Propionate ANDA NDC 33342-506

NDC codes

FDA NDC Directory

Product NDC (as listed)33342-506Labeler and product segments. Claims need a package NDC.

Product NDC at billing width33342-0506Add 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
33342-506-15	3334205061533342050615	1 TUBE in 1 CARTON (33342-506-15) / 15 g in 1 TUBEMarketed from Dec 28, 2023
33342-506-30	3334205063033342050630	1 TUBE in 1 CARTON (33342-506-30) / 30 g in 1 TUBEMarketed from Dec 28, 2023
33342-506-45	3334205064533342050645	1 TUBE in 1 CARTON (33342-506-45) / 45 g in 1 TUBEMarketed from Dec 28, 2023
33342-506-60	3334205066033342050660	1 TUBE in 1 CARTON (33342-506-60) / 60 g in 1 TUBEMarketed from Dec 28, 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): Clobetasol Propionate ANDASuffix: ANDA
Generic name (nonproprietary): clobetasol propionate
Active ingredients: Clobetasol propionate — .5 mg/g
Dosage form: Ointment
Route: Topical
Labeler: Macleods Pharmaceuticals LimitedNDC labeler code 33342
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 215990
Marketing start: Dec 28, 2023
Listing expires: Dec 31, 2026
Other FDA classes: Corticosteroid Hormone Receptor Agonists (Mechanism)
Identifiers: Product ID 33342-506_92cf4231-e301-4353-98d9-85206ec6ba96SPL ID 92cf4231-e301-4353-98d9-85206ec6ba96SPL set ID 92cf4231-e301-4353-98d9-85206ec6ba96RxCUI 861448UNII 779619577MUPC 0333342506603, 0333342506306
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

N433342050615 followed by a unit qualifier and the quantity

Package 33342-0506-15. 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 Jan 5, 2024.

Indications (excerpt from the label)

INDICATIONS & USAGE Clobetasol propionate ointment is 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/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 necessary.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 33342-506

What is NDC 33342-506?: 33342-506 is the product NDC for Clobetasol Propionate ANDA (clobetasol propionate), Clobetasol propionate .5 mg/g ointment, listed with the FDA by Macleods Pharmaceuticals Limited. It has 4 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Clobetasol Propionate ANDA (Clobetasol Propionate).
What is the active ingredient?: Clobetasol propionate.
Who is the labeler?: Macleods Pharmaceuticals Limited, NDC labeler code 33342. 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 ANDA?: None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other NDCs under ANDA 215990

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

FDA NDC Directory listings under ANDA 215990
Product	Strength	Form · route	Labeler	Product NDC
Clobetasol Propionate	Clobetasol propionate .5 mg/g	OintmentTopical	A-S Medication Solutions	50090-8001
Clobetasol Propionate	Clobetasol propionate .5 mg/g	OintmentTopical	NorthStar RxLLC	72603-855

Clobetasol Propionate ANDA (Clobetasol propionate) NDC 33342-506