Prescription drug · ANDA
Desonide Ointment, 0.05% NDC 21922-004
Desonide .5 mg/g · Ointment · Topical · Encube Ethicals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 21922-004-04 | 2192200040421922000404 | 1 TUBE in 1 CARTON (21922-004-04) / 15 g in 1 TUBEMarketed from Mar 20, 2019 | |
| 21922-004-07 | 2192200040721922000407 | 1 TUBE in 1 CARTON (21922-004-07) / 60 g in 1 TUBEMarketed from Mar 20, 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)
- Desonide Ointment, 0.05%
- Generic name (nonproprietary)
- desonide ointment, 0.05%
- Active ingredients
- Desonide — .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 210998
- Marketing start
- Listing expires
- Other FDA classes
- Corticosteroid Hormone Receptor Agonists (Mechanism)
- Identifiers
- Product ID 21922-004_545fde77-f6c2-4129-b67f-1f8eadd5efdeSPL ID 545fde77-f6c2-4129-b67f-1f8eadd5efdeSPL set ID 3d4d19d4-e47b-407e-9df4-fed5f3db91b9RxCUI 204135UNII J280872D1OUPC 0321922004076, 0321922004045
- 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
N421922000404followed by a unit qualifier and the quantityPackage 21922-0004-04. 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 Desonide ointment USP, 0.05% is a low potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses. It should not be used for longer than two weeks unless directed by a physician.
Excerpt only. Read the full label for complete information.
About NDC 21922-004
- What is NDC 21922-004?
- 21922-004 is the product NDC for Desonide Ointment, 0.05%, Desonide .5 mg/g ointment, listed with the FDA by Encube Ethicals, Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Desonide Ointment, 0.05%.
- What is the active ingredient?
- Desonide.
- 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 Desonide Ointment, 0.05%?
- 3 other product NDCs are listed under this name. See all Desonide Ointment, 0.05% NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Desonide Ointment, 0.05% products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Desonide Ointment, 0.05% | Desonide .5 mg/g | OintmentTopical | Bryant Ranch Prepack | 63629-8481 | 63629-8481-01 |
| Desonide Ointment, 0.05% | Desonide .5 mg/g | OintmentTopical | Bryant Ranch Prepack | 63629-8482 | 63629-8482-01 |
| Desonide Ointment, 0.05% | Desonide .5 mg/g | OintmentTopical | Bryant Ranch Prepack | 72162-1272 | 72162-1272-0272162-1272-06 |
Other NDCs under ANDA 210998
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 |
|---|---|---|---|---|
| Desonide Ointment, 0.05% | Desonide .5 mg/g | OintmentTopical | Bryant Ranch Prepack | 63629-8481 |
| Desonide Ointment, 0.05% | Desonide .5 mg/g | OintmentTopical | Bryant Ranch Prepack | 63629-8482 |
| Desonide Ointment, 0.05% | Desonide .5 mg/g | OintmentTopical | Bryant Ranch Prepack | 72162-1272 |