Prescription drug · ANDA
Desonide NDC 80425-0418
Desonide .5 mg/g · Cream · Topical · Advanced Rx of Tennessee, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 80425-0418-1 | 8042504180180425041801 | 1 TUBE in 1 CARTON (80425-0418-1) / 60 g in 1 TUBEMarketed from Jul 17, 2024 |
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)
- Desonide
- Generic name (nonproprietary)
- desonide
- Active ingredients
- Desonide — .5 mg/g
- Dosage form
- Cream
- Route
- Topical
- Labeler
- Advanced Rx of Tennessee, LLCNDC labeler code 80425
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 074027
- Marketing start
- Listing expires
- Other FDA classes
- Corticosteroid Hormone Receptor Agonists (Mechanism)
- Identifiers
- Product ID 80425-0418_1d76541f-80d7-2a55-e063-6294a90aa5f9SPL ID 1d76541f-80d7-2a55-e063-6294a90aa5f9SPL set ID 1d7632a7-0f27-9e5d-e063-6294a90ad21fRxCUI 349351UNII J280872D1O
- 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
N480425041801followed by a unit qualifier and the quantityPackage 80425-0418-01. 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)
INDICATIONS AND USAGE Desonide Cream, 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 80425-0418
- What is NDC 80425-0418?
- 80425-0418 is the product NDC for Desonide, Desonide .5 mg/g cream, listed with the FDA by Advanced Rx of Tennessee, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Desonide.
- What is the active ingredient?
- Desonide.
- Who is the labeler?
- Advanced Rx of Tennessee, LLC, NDC labeler code 80425. 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?
- 23 other product NDCs are listed under this name. See all Desonide NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Desonide 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 | Desonide .5 mg/g | CreamTopical | Alembic Pharmaceuticals Limited | 46708-632 | 46708-0632-1546708-0632-60 |
| Desonide | Desonide .5 mg/mL | LotionTopical | Alembic Pharmaceuticals Limited | 46708-550 | 46708-0550-1846708-0550-59 |
| Desonide | Desonide .5 mg/g | OintmentTopical | Alembic Pharmaceuticals Limited | 46708-485 | 46708-0485-1546708-0485-60 |
| Desonide | Desonide .5 mg/g | CreamTopical | Advanced Rx of Tennessee, LLC | 80425-0371 | 80425-0371-01 |
| Desonide | Desonide .5 mg/g | OintmentTopical | NORTHSTAR RX LLC | 72603-164 | 72603-0164-0172603-0164-02 |
| Desonide | Desonide .5 mg/g | CreamTopical | Alembic Pharmaceuticals Inc. | 62332-632 | 62332-0632-1562332-0632-60 |
| Desonide | Desonide .5 mg/mL | LotionTopical | Alembic Pharmaceuticals Inc. | 62332-550 | 62332-0550-1862332-0550-59 |
| Desonide | Desonide .5 mg/g | GelTopical | Cintex Services, LLC | 24470-920 | 24470-0920-60 |
| Desonide | Desonide .5 mg/g | CreamTopical | Bryant Ranch Prepack | 63629-2506 | 63629-2506-01 |
| Desonide | Desonide .5 mg/g | CreamTopical | Bryant Ranch Prepack | 63629-2507 | 63629-2507-01 |
Other NDCs under ANDA 074027
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 | Desonide .5 mg/g | CreamTopical | Cosette Pharmaceuticals, Inc. | 0713-0661 |