NDC codes

FDA NDC Directory
Product NDC (as listed)63629-9461Labeler and product segments. Claims need a package NDC.
Product NDC at billing width63629-9461Add 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 NDC11-digit (billing)PackageCopy
63629-9461-1636299461011 BOTTLE in 1 CARTON (63629-9461-1) / 118 mL in 1 BOTTLEMarketed from Oct 31, 2022

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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/100mL
Dosage form
Shampoo
Route
Topical
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 090974
Marketing start
Listing expires
Other FDA classes
Corticosteroid Hormone Receptor Agonists (Mechanism)
Identifiers
Product ID 63629-9461_f9b3e552-f35b-49d5-83a8-f6c3b2f8e1d5SPL ID f9b3e552-f35b-49d5-83a8-f6c3b2f8e1d5SPL set ID 40c3b94f-a61c-4fc1-a411-5bf4e3fe6791RxCUI 861490UNII 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

N463629946101 followed by a unit qualifier and the quantity

Package 63629-9461-01. 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 .

Indications (excerpt from the label)

Clobetasol Propionate Shampoo, 0.05% is a translucent, colorless viscous liquid, supplied in 4 fl. oz. (118 mL) bottles. NDC 63629-9461-01 Storage: Keep bottle tightly closed. Store at USP controlled room temperature 68° to 77°F (20° - 25°C), with excursions permitted between 59° and 86°F (15° - 30°C). Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504 1.1 Indication 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 …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

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
ProductStrengthForm · routeLabelerProduct NDC
clobetasol propionateClobetasol propionate .05 g/100mLShampooTopicalPadagis Israel Pharmaceuticals Ltd45802-961
clobetasol propionateClobetasol propionate .05 g/100mLShampooTopicalBryant Ranch Prepack72162-1442
Clodanclobetasol propionateClobetasol propionate .5 mg/mLShampooTopicalMedimetriks Pharmaceuticals43538-950

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