Prescription drug · ANDA
Dexamethasone NDC 0054-3177
Dexamethasone .5 mg/5mL · Solution · Oral · Hikma Pharmaceuticals USA, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0054-3177-57 | 00054317757 | 240 mL in 1 BOTTLE, PLASTIC (0054-3177-57)Marketed from Nov 1, 2007 | |
| 0054-3177-63 | 00054317763 | 500 mL in 1 BOTTLE, PLASTIC (0054-3177-63)Marketed from Sep 1, 1983 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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
- Generic name (nonproprietary)
- dexamethasone
- Active ingredients
- Dexamethasone — .5 mg/5mL
- Dosage form
- Solution
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 088248
- Marketing start
- Listing expires
- Other FDA classes
- Corticosteroid Hormone Receptor Agonists (Mechanism)
- Identifiers
- Product ID 0054-3177_286734bc-8329-4f44-a20b-610cf7b67591SPL ID 286734bc-8329-4f44-a20b-610cf7b67591SPL set ID b15200fb-1826-472b-a907-e677a272513bRxCUI 197577, 197579, 197580, 197581, 197582, 197583, 309684, 309686, 343033UNII 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
N400054317757followed by a unit qualifier and the quantityPackage 00054-3177-57. 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.