Prescription drug · ANDA
dexamethasone NDC 0904-7444
Dexamethasone 2 mg/1 · Tablet · Oral · Major Pharmaceuticals
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0904-7444-61 | 00904744461 | 100 BLISTER PACK in 1 CARTON (0904-7444-61) / 1 TABLET in 1 BLISTER PACKMarketed from Aug 26, 2024 |
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 — 2 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Major PharmaceuticalsNDC labeler code 0904
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 216295
- Marketing start
- Listing expires
- Other FDA classes
- Corticosteroid Hormone Receptor Agonists (Mechanism)
- Identifiers
- Product ID 0904-7444_7a409708-7462-4a75-8d0b-6054f3523ac9SPL ID 7a409708-7462-4a75-8d0b-6054f3523ac9SPL set ID 5ec5b0e6-7fa8-4afc-97a4-d185484ada8bRxCUI 197581UNII 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
N400904744461followed by a unit qualifier and the quantityPackage 00904-7444-61. 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.
About NDC 0904-7444
- What is NDC 0904-7444?
- 0904-7444 is the product NDC for dexamethasone, Dexamethasone 2 mg/1 tablet, listed with the FDA by Major Pharmaceuticals. 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?
- Major Pharmaceuticals, NDC labeler code 0904. 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?
- 135 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 .25 mg/1 | TabletOral | Pangea Pharmaceuticals, LLC | 81279-117 | 81279-0117-88 |
| 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 | Kanchan Healthcare Inc | 85742-004 | 85742-0004-03 |
| Dexamethasone | Dexamethasone .5 mg/5mL | ElixirOral | Bryant Ranch Prepack | 72162-2600 | 72162-2600-02 |
| Dexamethasone | Dexamethasone .75 mg/1 | TabletOral | Advagen Pharma Ltd. | 72888-236 | 72888-0236-01 |
| Dexamethasone | Dexamethasone .5 mg/1 | TabletOral | Advagen Pharma Ltd. | 72888-235 | 72888-0235-01 |
Other NDCs under ANDA 216295
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 2 mg/1 | TabletOral | Amneal Pharmaceuticals NY LLC | 60219-2056 |