Prescription drug · ANDA
Dexamethasone NDC 80425-0515
Dexamethasone 4 mg/1 · Tablet · Oral · Advanced Rx of Tennessee, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 80425-0515-1 | 8042505150180425051501 | 12 TABLET in 1 BOTTLE (80425-0515-1)Marketed from May 7, 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
- Advanced Rx of Tennessee, LLCNDC labeler code 80425
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 217001
- Marketing start
- Listing expires
- Other FDA classes
- Corticosteroid Hormone Receptor Agonists (Mechanism)
- Identifiers
- Product ID 80425-0515_348f5a61-1623-3f2f-e063-6394a90addbeSPL ID 348f5a61-1623-3f2f-e063-6394a90addbeSPL set ID 348f5a56-978d-4272-e063-6294a90afdb6RxCUI 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
N480425051501followed by a unit qualifier and the quantityPackage 80425-0515-01. 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)
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 mineralocort…
Excerpt only. Read the full label for complete information.
About NDC 80425-0515
- What is NDC 80425-0515?
- 80425-0515 is the product NDC for Dexamethasone, Dexamethasone 4 mg/1 tablet, listed with the FDA by Advanced Rx of Tennessee, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Dexamethasone.
- What is the active ingredient?
- Dexamethasone.
- Who is the labeler?
- Advanced Rx of Tennessee, LLC, NDC labeler code 80425. 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?
- 134 other product NDCs are listed under this name. See all Dexamethasone NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Dexamethasone 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 | Dexamethasone 4 mg/1 | TabletOral | Preferred Pharmaceuticals Inc | 68788-4113 | 68788-4113-0168788-4113-0368788-4113-05+1 more |
| Dexamethasone | Dexamethasone .5 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4669 | 70518-4669-00 |
| Dexamethasone | Dexamethasone .25 mg/1 | TabletOral | Pangea Pharmaceuticals, LLC | 81279-117 | 81279-0117-60 |
| Dexamethasone | Dexamethasone .5 mg/5mL | ElixirOral | ANI Pharmaceuticals, Inc. | 70954-872 | 70954-0872-10 |
| Dexamethasone | Dexamethasone 4 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 72789-534 | 72789-0534-0172789-0534-2872789-0534-95 |
| Dexamethasone | Dexamethasone .5 mg/5mL | ElixirOral | Bryant Ranch Prepack | 72162-2600 | 72162-2600-02 |
| Dexamethasone | Dexamethasone .5 mg/5mL | ElixirOral | Kanchan Healthcare Inc | 85742-004 | 85742-0004-03 |
| Dexamethasone | Dexamethasone 1.5 mg/1 | TabletOral | NuCare Pharmaceuticals, Inc. | 68071-3962 | 68071-3962-03 |
| Dexamethasone | Dexamethasone .5 mg/1 | TabletOral | Advagen Pharma Ltd. | 72888-235 | 72888-0235-01 |
| Dexamethasone | Dexamethasone .75 mg/1 | TabletOral | Advagen Pharma Ltd. | 72888-236 | 72888-0236-01 |
Other NDCs under ANDA 217001
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 | Preferred Pharmaceuticals Inc. | 68788-8824 |
| Dexamethasone | Dexamethasone 4 mg/1 | TabletOral | Bionpharma Inc., | 69452-277 |
| Dexamethasone | Dexamethasone 6 mg/1 | TabletOral | Bionpharma Inc., | 69452-278 |
| Dexamethasone | Dexamethasone 4 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2500 |
| Dexamethasone | Dexamethasone 4 mg/1 | TabletOral | Proficient Rx LP | 82804-254 |
| Dexamethasone | Dexamethasone 4 mg/1 | TabletOral | Sportpharm LLC | 85766-246 |
| Dexamethasone | Dexamethasone 6 mg/1 | TabletOral | Sportpharm LLC | 85766-247 |