Prescription drug · ANDA
Dexamethasone NDC 47781-916
Dexamethasone 6 mg/1 · Tablet · Oral · Alvogen Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 47781-916-01 | 4778109160147781091601 | 100 TABLET in 1 BOTTLE (47781-916-01)Marketed from Aug 30, 2021 |
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 — 6 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Alvogen Inc.NDC labeler code 47781
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 088481
- Marketing start
- Listing expires
- Other FDA classes
- Corticosteroid Hormone Receptor Agonists (Mechanism)
- Identifiers
- Product ID 47781-916_f5d1d20f-dcb0-9ddf-b436-165cf014f5faSPL ID f5d1d20f-dcb0-9ddf-b436-165cf014f5faSPL set ID 9ab26af9-8196-e3d3-76a3-75227fd4e1c3RxCUI 197582, 197583UNII 7S5I7G3JQLUPC 0347781916015, 0347781914011
- 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
N447781091601followed by a unit qualifier and the quantityPackage 47781-0916-01. 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, seasonal or perennial 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 mineralocorticoi…
Excerpt only. Read the full label for complete information.
About NDC 47781-916
- What is NDC 47781-916?
- 47781-916 is the product NDC for Dexamethasone, Dexamethasone 6 mg/1 tablet, listed with the FDA by Alvogen Inc.. 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?
- Alvogen Inc., NDC labeler code 47781. 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 088481
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 | Alvogen Inc. | 47781-914 |
| Dexamethasone | Dexamethasone 4 mg/1 | TabletOral | Redpharm Drug, Inc. | 67296-1837 |
| Dexamethasone | Dexamethasone 4 mg/1 | TabletOral | Proficient Rx LP | 71205-703 |
| Dexamethasone | Dexamethasone 4 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2108 |
| Dexamethasone | Dexamethasone 4 mg/1 | TabletOral | Advanced Rx Pharmacy of Tennessee, LLC | 80425-0328 |