Prescription drug · ANDA
Dexamethasone NDC 72789-534
Dexamethasone 4 mg/1 · Tablet · Oral · PD-Rx Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72789-534-01 | 72789053401 | 100 TABLET in 1 BOTTLE, PLASTIC (72789-534-01)Marketed from Nov 21, 2025 | |
| 72789-534-28 | 72789053428 | 28 TABLET in 1 BOTTLE, PLASTIC (72789-534-28)Marketed from Dec 9, 2025 | |
| 72789-534-95 | 72789053495 | 1000 TABLET in 1 BOTTLE, PLASTIC (72789-534-95)Marketed from Nov 21, 2025 |
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
- Generic name (nonproprietary)
- dexamethasone
- Active ingredients
- Dexamethasone — 4 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- PD-Rx Pharmaceuticals, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 218372
- Marketing start
- Listing expires
- Other FDA classes
- Corticosteroid Hormone Receptor Agonists (Mechanism)
- Identifiers
- Product ID 72789-534_4589a128-79eb-aa64-e063-6294a90a953bSPL ID 4589a128-79eb-aa64-e063-6294a90a953bSPL set ID a8d6792e-757e-4dc6-adf5-0d9211075428RxCUI 197582UNII 7S5I7G3JQLUPC 0372789534954
- 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
N472789053401followed by a unit qualifier and the quantityPackage 72789-0534-01. 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)
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 supplementation is …
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 218372
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 | NuCare Pharmaceuticals, Inc. | 68071-3962 |
| Dexamethasone | Dexamethasone .75 mg/1 | TabletOral | Advagen Pharma Ltd. | 72888-236 |
| Dexamethasone | Dexamethasone .5 mg/1 | TabletOral | Advagen Pharma Ltd. | 72888-235 |
| Dexamethasone | Dexamethasone 2 mg/1 | TabletOral | Advagen Pharma Ltd. | 72888-239 |
| Dexamethasone | Dexamethasone 1 mg/1 | TabletOral | Advagen Pharma Ltd. | 72888-237 |
| Dexamethasone | Dexamethasone 1.5 mg/1 | TabletOral | Advagen Pharma Ltd. | 72888-238 |
| Dexamethasone | Dexamethasone 4 mg/1 | TabletOral | Advagen Pharma Ltd. | 72888-240 |
| Dexamethasone | Dexamethasone 6 mg/1 | TabletOral | Advagen Pharma Ltd. | 72888-241 |