Prescription drug · ANDA
Clobetasol Propionate NDC 21922-017
clobetasol propionate ointment usp, 0.05% · Clobetasol propionate .5 mg/g · Ointment · Topical · Encube Ethicals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 21922-017-04 | 2192200170421922001704 | 1 TUBE in 1 CARTON (21922-017-04) / 15 g in 1 TUBEMarketed from Nov 18, 2019 | |
| 21922-017-05 | 2192200170521922001705 | 1 TUBE in 1 CARTON (21922-017-05) / 30 g in 1 TUBEMarketed from Nov 18, 2019 | |
| 21922-017-06 | 2192200170621922001706 | 1 TUBE in 1 CARTON (21922-017-06) / 45 g in 1 TUBEMarketed from Nov 18, 2019 | |
| 21922-017-07 | 2192200170721922001707 | 1 TUBE in 1 CARTON (21922-017-07) / 60 g in 1 TUBEMarketed from Nov 18, 2019 |
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
- Generic name (nonproprietary)
- clobetasol propionate ointment usp, 0.05%
- Active ingredients
- Clobetasol propionate — .5 mg/g
- Dosage form
- Ointment
- Route
- Topical
- Labeler
- Encube Ethicals, Inc.NDC labeler code 21922
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 211295
- Marketing start
- Listing expires
- Other FDA classes
- Corticosteroid Hormone Receptor Agonists (Mechanism)
- Identifiers
- Product ID 21922-017_48be3668-cb36-453e-b408-bf39abbdc17cSPL ID 48be3668-cb36-453e-b408-bf39abbdc17cSPL set ID 1f076779-3f76-47d5-99f0-9b0b2d3f5facRxCUI 861448UNII 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
N421922001704followed by a unit qualifier and the quantityPackage 21922-0017-04. 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 .
Indications (excerpt from the label)
INDICATIONS AND USAGE Clobetasol propionate ointment USP, 0.05% 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.
About NDC 21922-017
- What is NDC 21922-017?
- 21922-017 is the product NDC for Clobetasol Propionate, Clobetasol propionate .5 mg/g ointment, listed with the FDA by Encube Ethicals, Inc.. It has 4 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Clobetasol Propionate (Clobetasol Propionate Ointment USP, 0.05%).
- What is the active ingredient?
- Clobetasol propionate.
- Who is the labeler?
- Encube Ethicals, Inc., NDC labeler code 21922. 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 211295
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 Propionateclobetasol propionate ointment usp, 0.05% | Clobetasol propionate .5 mg/g | OintmentTopical | Bryant Ranch Prepack | 63629-2457 |
| Clobetasol Propionateclobetasol propionate ointment usp, 0.05% | Clobetasol propionate .5 mg/g | OintmentTopical | Bryant Ranch Prepack | 63629-2455 |
| Clobetasol Propionateclobetasol propionate ointment usp, 0.05% | Clobetasol propionate .5 mg/g | OintmentTopical | Bryant Ranch Prepack | 63629-2456 |
| Clobetasol Propionateclobetasol propionate ointment usp, 0.05% | Clobetasol propionate .5 mg/g | OintmentTopical | Bryant Ranch Prepack | 63629-2458 |
| Clobetasol Propionateclobetasol propionate usp, 0.05% | Clobetasol propionate .5 mg/g | OintmentTopical | A-S Medication Solutions | 50090-6731 |
| Clobetasol Propionateclobetasol propionate ointment, 0.05% | Clobetasol propionate .5 mg/g | OintmentTopical | Preferred Pharmaceuticals Inc. | 68788-7963 |
| Clobetasol Propionateclobetasol propionate ointment usp, 0.05% | Clobetasol propionate .5 mg/g | OintmentTopical | Bryant Ranch Prepack | 72162-1273 |
| Clobetasol Propionateclobetasol propionate ointment usp, 0.05% | Clobetasol propionate .5 mg/g | OintmentTopical | Bryant Ranch Prepack | 71335-2837 |
| Clobetasol Propionateclobetasol propionate ointment usp, 0.05% | Clobetasol propionate .5 mg/g | OintmentTopical | Bryant Ranch Prepack | 71335-2851 |
| Clobetasol Propionateclobetasol propionate ointment usp, 0.05% | Clobetasol propionate .5 mg/g | OintmentTopical | Bryant Ranch Prepack | 71335-2859 |
| Clobetasol Propionateclobetasol propionate ointment usp, 0.05% | Clobetasol propionate .5 mg/g | OintmentTopical | Bryant Ranch Prepack | 71335-2860 |