Prescription drug · ANDA
Dexamethasone NDC 68788-8763
Dexamethasone .75 mg/1 · Tablet · Oral · Preferred Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68788-8763-0 | 68788876300 | 100 TABLET in 1 BOTTLE (68788-8763-0)Marketed from Nov 11, 2024 | |
| 68788-8763-1 | 68788876301 | 12 TABLET in 1 BOTTLE (68788-8763-1)Marketed from Nov 11, 2024 | |
| 68788-8763-2 | 68788876302 | 21 TABLET in 1 BOTTLE (68788-8763-2)Marketed from Nov 11, 2024 | |
| 68788-8763-3 | 68788876303 | 30 TABLET in 1 BOTTLE (68788-8763-3)Marketed from Nov 11, 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)
- Dexamethasone
- Generic name (nonproprietary)
- dexamethasone
- Active ingredients
- Dexamethasone — .75 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 216282
- Marketing start
- Listing expires
- Other FDA classes
- Corticosteroid Hormone Receptor Agonists (Mechanism)
- Identifiers
- Product ID 68788-8763_86f71920-d9ff-41d1-a70e-b90c446f6db6SPL ID 86f71920-d9ff-41d1-a70e-b90c446f6db6SPL set ID 64577454-d49e-4180-99e6-8461f74b0221RxCUI 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
N468788876300followed by a unit qualifier and the quantityPackage 68788-8763-00. 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 mineralocorticoid…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 216282
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 | Dexamethasone 1.5 mg/1 | TabletOral | Viona Pharmaceuticals Inc | 72578-170 |
| Dexamethasone | Dexamethasone .5 mg/1 | TabletOral | Viona Pharmaceuticals Inc | 72578-168 |
| Dexamethasone | Dexamethasone .75 mg/1 | TabletOral | Viona Pharmaceuticals Inc | 72578-169 |
| Dexamethasone | Dexamethasone 4 mg/1 | TabletOral | Viona Pharmaceuticals Inc | 72578-171 |
| Dexamethasone | Dexamethasone 6 mg/1 | TabletOral | Viona Pharmaceuticals Inc | 72578-172 |
| Dexamethasone | Dexamethasone 4 mg/1 | TabletOral | Zydus Lifesciences Limited | 70771-1699 |
| Dexamethasone | Dexamethasone 6 mg/1 | TabletOral | Zydus Lifesciences Limited | 70771-1700 |
| Dexamethasone | Dexamethasone .5 mg/1 | TabletOral | Zydus Lifesciences Limited | 70771-1704 |
| Dexamethasone | Dexamethasone .75 mg/1 | TabletOral | Zydus Lifesciences Limited | 70771-1705 |
| Dexamethasone | Dexamethasone 1.5 mg/1 | TabletOral | Zydus Lifesciences Limited | 70771-1707 |
| Dexamethasone | Dexamethasone 4 mg/1 | TabletOral | Preferred Pharmaceuticals Inc | 68788-4113 |
| Dexamethasone | Dexamethasone 1.5 mg/1 | TabletOral | Direct_rx | 72189-572 |
| Dexamethasone | Dexamethasone 4 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-3054 |
| Dexamethasone | Dexamethasone .5 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4669 |
| Dexamethasone | Dexamethasone .75 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 72789-501 |