Prescription drug · ANDA
Dexamethasone NDC 70518-4320
Dexamethasone 4 mg/1 · Tablet · Oral · REMEDYREPACK INC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70518-4320-0 | 70518432000 | 4 TABLET in 1 BOTTLE, PLASTIC (70518-4320-0)Marketed from Mar 25, 2025 |
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 — 4 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- REMEDYREPACK INC.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 215604
- Marketing start
- Listing expires
- Other FDA classes
- Corticosteroid Hormone Receptor Agonists (Mechanism)
- Identifiers
- Product ID 70518-4320_5aa9f032-7fef-7eae-e063-6294a90abd6bSPL ID 5aa9f032-7fef-7eae-e063-6294a90abd6bSPL set ID 8c5375a7-7a0d-4af0-8b86-bc87698ac3d1RxCUI 197582UNII 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
N470518432000followed by a unit qualifier and the quantityPackage 70518-4320-00. 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 & 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 215604
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 4 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-3603 |
| Dexamethasone | Dexamethasone .75 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2405 |
| Dexamethasone | Dexamethasone 1.5 mg/1 | TabletOral | Direct_Rx | 72189-468 |
| Dexamethasone | Dexamethasone 4 mg/1 | TabletOral | Direct_Rx | 72189-511 |
| Dexamethasone | Dexamethasone 4 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2227 |
| Dexamethasone | Dexamethasone 4 mg/1 | TabletOral | American Health Packaging | 60687-718 |
| Dexamethasone | Dexamethasone 6 mg/1 | TabletOral | American Health Packaging | 60687-729 |
| Dexamethasone | Dexamethasone 1.5 mg/1 | TabletOral | NorthStar Rx LLC | 72603-187 |
| Dexamethasone | Dexamethasone 4 mg/1 | TabletOral | NorthStar Rx LLC | 72603-189 |
| Dexamethasone | Dexamethasone 6 mg/1 | TabletOral | NorthStar Rx LLC | 72603-190 |
| Dexamethasone | Dexamethasone 1.5 mg/1 | TabletOral | ANI Pharmaceuticals, Inc. | 70954-401 |
| Dexamethasone | Dexamethasone .5 mg/.5mg | TabletOral | NorthStar Rx LLC | 72603-212 |
| Dexamethasone | Dexamethasone .5 mg/1 | TabletOral | ANI Pharmaceuticals, Inc. | 70954-398 |
| Dexamethasone | Dexamethasone .75 mg/1 | TabletOral | ANI Pharmaceuticals, Inc. | 70954-399 |
| Dexamethasone | Dexamethasone .75 mg/.75mg | TabletOral | NorthStar Rx LLC | 72603-213 |
| Dexamethasone | Dexamethasone 4 mg/1 | TabletOral | ANI Pharmaceuticals, Inc. | 70954-403 |
| Dexamethasone | Dexamethasone 6 mg/1 | TabletOral | ANI Pharmaceuticals, Inc. | 70954-404 |
| Dexamethasone | Dexamethasone 4 mg/1 | TabletOral | Preferred Pharmaceuticals, Inc. | 68788-8467 |
| Dexamethasone | Dexamethasone 4 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-3588 |