Prescription drug · ANDA
Dexamethasone NDC 71335-2108
Dexamethasone 4 mg/1 · Tablet · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71335-2108-0 | 71335210800 | 4 TABLET in 1 BOTTLE (71335-2108-0)Marketed from May 4, 2023 | |
| 71335-2108-1 | 71335210801 | 30 TABLET in 1 BOTTLE (71335-2108-1)Marketed from Feb 3, 2023 | |
| 71335-2108-2 | 71335210802 | 6 TABLET in 1 BOTTLE (71335-2108-2)Marketed from Jun 9, 2022 | |
| 71335-2108-3 | 71335210803 | 3 TABLET in 1 BOTTLE (71335-2108-3)Marketed from Aug 25, 2022 | |
| 71335-2108-4 | 71335210804 | 15 TABLET in 1 BOTTLE (71335-2108-4)Marketed from Aug 9, 2022 | |
| 71335-2108-5 | 71335210805 | 40 TABLET in 1 BOTTLE (71335-2108-5)Marketed from Apr 3, 2024 | |
| 71335-2108-6 | 71335210806 | 60 TABLET in 1 BOTTLE (71335-2108-6)Marketed from Apr 3, 2024 | |
| 71335-2108-7 | 71335210807 | 28 TABLET in 1 BOTTLE (71335-2108-7)Marketed from Feb 10, 2023 | |
| 71335-2108-8 | 71335210808 | 90 TABLET in 1 BOTTLE (71335-2108-8)Marketed from Apr 3, 2024 | |
| 71335-2108-9 | 71335210809 | 10 TABLET in 1 BOTTLE (71335-2108-9)Marketed from Aug 1, 2022 |
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
- Bryant Ranch Prepack
- 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 71335-2108_47ef46ae-6174-4863-8d17-303cb456d663SPL ID 47ef46ae-6174-4863-8d17-303cb456d663SPL set ID 36f104ba-80b4-4713-aa74-f80483b7bdedRxCUI 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
N471335210800followed by a unit qualifier and the quantityPackage 71335-2108-00. 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 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.
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 6 mg/1 | TabletOral | Alvogen Inc. | 47781-916 |
| Dexamethasone | Dexamethasone 4 mg/1 | TabletOral | Proficient Rx LP | 71205-703 |
| Dexamethasone | Dexamethasone 4 mg/1 | TabletOral | Advanced Rx Pharmacy of Tennessee, LLC | 80425-0328 |
| Dexamethasone | Dexamethasone 4 mg/1 | TabletOral | Redpharm Drug, Inc. | 67296-1837 |