Prescription drug · ANDA
clobetasol propionate NDC 63629-9461
Clobetasol propionate .05 g/100mL · Shampoo · Topical · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63629-9461-1 | 6362994610163629946101 | 1 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
- Labeler
- Bryant Ranch PrepackNDC labeler code 63629
- 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
N463629946101followed by a unit qualifier and the quantityPackage 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.
About NDC 63629-9461
- What is NDC 63629-9461?
- 63629-9461 is the product NDC for clobetasol propionate, Clobetasol propionate .05 g/100mL shampoo, listed with the FDA by Bryant Ranch Prepack. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- clobetasol propionate.
- What is the active ingredient?
- Clobetasol propionate.
- Who is the labeler?
- Bryant Ranch Prepack, NDC labeler code 63629. 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?
- 96 other product NDCs are listed under this name. See all clobetasol propionate NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other clobetasol propionate products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Clobetasol Propionate | Clobetasol propionate .5 mg/g | OintmentTopical | A-S Medication Solutions | 50090-8001 | 50090-8001-00 |
| Clobetasol Propionate | Clobetasol propionate .5 mg/g | OintmentTopical | NorthStar RxLLC | 72603-855 | 72603-0855-0172603-0855-0272603-0855-03+1 more |
| Clobetasol Propionate | Clobetasol propionate .5 mg/g | Aerosol, FoamTopical | Alembic Pharmaceuticals Limited | 46708-707 | 46708-0707-3146708-0707-50 |
| Clobetasol Propionate | Clobetasol propionate .5 mg/g | CreamTopical | Alembic Pharmaceuticals Limited | 46708-547 | 46708-0547-1546708-0547-3046708-0547-45+1 more |
| Clobetasol Propionate | Clobetasol propionate .05 g/100mL | ShampooTopical | Alembic Pharmaceuticals Limited | 46708-548 | 46708-0548-04 |
| Clobetasol Propionate | Clobetasol propionate .5 mg/mL | SolutionTopical | Alembic Pharmaceuticals Limited | 46708-486 | 46708-0486-2546708-0486-50 |
| Clobetasol Propionate | Clobetasol propionate .05 g/mL | SprayTopical | Alembic Pharmaceuticals Limited | 46708-425 | 46708-0425-1246708-0425-59 |
| Clobetasol Propionate | Clobetasol propionate .5 mg/g | OintmentTopical | Alembic Pharmaceuticals Limited | 46708-465 | 46708-0465-1546708-0465-3046708-0465-45+1 more |
| Clobetasol Propionate | Clobetasol propionate .25 mg/g | CreamTopical | INA Pharmaceutics Inc | 74157-710 | 74157-0710-10 |
| Clobetasol Propionate | Clobetasol propionate .5 mg/g | CreamTopical | Torrent Pharmaceuticals Limited | 13668-569 | 13668-0569-0113668-0569-0213668-0569-04+1 more |
Other NDCs under ANDA 090974
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| 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 | 72162-1442 |
| Clodanclobetasol propionate | Clobetasol propionate .5 mg/mL | ShampooTopical | Medimetriks Pharmaceuticals | 43538-950 |