Prescription drug · ANDA
Dexamethasone Intensol NDC 85766-264
Dexamethasone 1 mg/mL · Solution, Concentrate · Oral · Sportpharm LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 85766-264-30 | 8576602643085766026430 | 30 mL in 1 BOTTLE, GLASS (85766-264-30)Marketed from Aug 21, 2026 |
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)
- Dexamethasone Intensol
- Generic name (nonproprietary)
- dexamethasone intensol
- Active ingredients
- Dexamethasone — 1 mg/mL
- Dosage form
- Solution, Concentrate
- Route
- Oral
- Labeler
- Sportpharm LLCNDC labeler code 85766
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 088252
- Marketing start
- Listing expires
- Other FDA classes
- Corticosteroid Hormone Receptor Agonists (Mechanism)
- Identifiers
- Product ID 85766-264_5987bb27-7262-c69e-e063-6394a90ac820SPL ID 5987bb27-7262-c69e-e063-6394a90ac820SPL set ID 77429dd3-e66d-4ab4-a3f3-5ae0b987ac17RxCUI 309684UNII 7S5I7G3JQL
- 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. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N485766026430followed by a unit qualifier and the quantityPackage 85766-0264-30. 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 Allergic States Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, perennial or seasonal allergic rhinitis, and serum sickness. Dermatologic Diseases Bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus, and severe erythema multiforme (Stevens-Johnson syndrome). Endocrine Disorders Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; may be used in conjunction with synthetic mineralocorticoid analogs where applicable; in infancy mineralocortico…
Excerpt only. Read the full label for complete information.
About NDC 85766-264
- What is NDC 85766-264?
- 85766-264 is the product NDC for Dexamethasone Intensol, Dexamethasone 1 mg/mL solution, concentrate, listed with the FDA by Sportpharm LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Dexamethasone Intensol.
- What is the active ingredient?
- Dexamethasone.
- Who is the labeler?
- Sportpharm LLC, NDC labeler code 85766. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Dexamethasone Intensol?
- 1 other product NDC are listed under this name. See all Dexamethasone Intensol NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Dexamethasone Intensol products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Dexamethasone Intensol | Dexamethasone 1 mg/mL | Solution, ConcentrateOral | Hikma Pharmaceuticals USA, Inc. | 0054-3176 | 00054-3176-44 |
Other NDCs under ANDA 088252
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 |
|---|---|---|---|---|
| Dexamethasone Intensol | Dexamethasone 1 mg/mL | Solution, ConcentrateOral | Hikma Pharmaceuticals USA, Inc. | 0054-3176 |