What is NDC 43538-950?

43538-950 is the product NDC for Clodan (clobetasol propionate), Clobetasol propionate .5 mg/mL shampoo, listed with the FDA by Medimetriks Pharmaceuticals. It has 1 package NDC, shown above in 10- and 11-digit form.

Medimetriks Pharmaceuticals, NDC labeler code 43538. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Clodan?

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.

Clodan NDC 43538-950 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)43538-950Labeler and product segments. Claims need a package NDC.

Product NDC at billing width43538-0950Add 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
43538-950-04	4353809500443538095004	1 BOTTLE in 1 CARTON (43538-950-04) / 118 mL in 1 BOTTLEMarketed from Jun 22, 2014

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): Clodan
Generic name (nonproprietary): clobetasol propionate
Active ingredients: Clobetasol propionate — .5 mg/mL
Dosage form: Shampoo
Route: Topical
Labeler: Medimetriks PharmaceuticalsNDC labeler code 43538
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 090974
Marketing start: Jun 22, 2014
Listing expires: Dec 31, 2027
Other FDA classes: Corticosteroid Hormone Receptor Agonists (Mechanism)
Identifiers: Product ID 43538-950_d9fb3d50-fdde-4dc7-af7c-c8c2c039fc51SPL ID d9fb3d50-fdde-4dc7-af7c-c8c2c039fc51SPL set ID b5d32546-65dc-4b0c-826e-ddbc2a50b152RxCUI 861490, 1541099UNII 779619577MUPC 0343538950042
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

N443538095004 followed by a unit qualifier and the quantity

Package 43538-0950-04. 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 20, 2023.

Indications (excerpt from the label)

Clodan ® (clobetasol propionate) Shampoo, 0.05% is a corticosteroid indicated for the treatment of moderate to severe scalp psoriasis in subjects 18 years of age and older ( 1 ). Limitations of Use: Do not use on the face, axillae or groin. ( 1.2 ) Avoid any contact with the eyes and lips. ( 1.2 ) 1.1 Indication Clodan ® (clobetasol propionate) Shampoo, 0.05% is a super-high potent topical corticosteroid formulation indicated for the treatment of moderate to severe forms of scalp psoriasis in subjects 18 years of age and older. Treatment should be limited to 4 consecutive weeks. The total dosage should not exceed 50 g (50 mL or 1.75 fl. oz.) per week. Patients should be instructed to use Clo…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 43538-950

What is NDC 43538-950?: 43538-950 is the product NDC for Clodan (clobetasol propionate), Clobetasol propionate .5 mg/mL shampoo, listed with the FDA by Medimetriks Pharmaceuticals. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Clodan (Clobetasol propionate).
What is the active ingredient?: Clobetasol propionate.
Who is the labeler?: Medimetriks Pharmaceuticals, NDC labeler code 43538. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Clodan?: 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 090974

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

FDA NDC Directory listings under ANDA 090974
Product	Strength	Form · route	Labeler	Product NDC
clobetasol propionate	Clobetasol propionate .05 g/100mL	ShampooTopical	Padagis Israel Pharmaceuticals Ltd	45802-961
clobetasol propionate	Clobetasol propionate .05 g/100mL	ShampooTopical	Bryant Ranch Prepack	63629-9461
clobetasol propionate	Clobetasol propionate .05 g/100mL	ShampooTopical	Bryant Ranch Prepack	72162-1442

Clodan (Clobetasol propionate) NDC 43538-950