Prescription drug · ANDA
Dexamethasone Sodium Phosphate NDC 0641-6146
Dexamethasone sodium phosphate 4 mg/mL · Injection · Intra-articular, Intralesional, Intramuscular, Intravenous, Soft tissue · Hikma Pharmaceuticals USA Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0641-6146-10 | 00641614610 | 10 VIAL in 1 CARTON (0641-6146-10) / 5 mL in 1 VIAL (0641-6146-01)Marketed from Oct 3, 2023 | |
| 0641-6146-25 | 00641614625 | 25 VIAL in 1 CARTON (0641-6146-25) / 5 mL in 1 VIAL (0641-6146-01)Marketed from Jul 15, 1975 |
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 Sodium Phosphate
- Generic name (nonproprietary)
- dexamethasone sodium phosphate
- Active ingredients
- Dexamethasone sodium phosphate — 4 mg/mL
- Dosage form
- Injection
- Route
- Intra-articular, Intralesional, Intramuscular, Intravenous, Soft tissue
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 084282
- Marketing start
- Listing expires
- Other FDA classes
- Corticosteroid Hormone Receptor Agonists (Mechanism)
- Identifiers
- Product ID 0641-6146_02bf3273-f0c8-448c-9f74-eb009fee9299SPL ID 02bf3273-f0c8-448c-9f74-eb009fee9299SPL set ID 0277cc0a-2fd4-4605-a310-b613be84ee26RxCUI 309696, 1116927, 1812194UNII AI9376Y64P
- 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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- Administration
Drug administration (CPT 96360–96549)
When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.
- NDC on a medical claim
N400641614610followed by a unit qualifier and the quantityPackage 00641-6146-10. 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 A. Intravenous or intramuscular administration. When oral therapy is not feasible and the strength, dosage form, and route of administration of the drug reasonably lend the preparation to the treatment of the condition, those products labeled for intravenous or intramuscular use are indicated as follows: 1. Endocrine disorders Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy, mineralocorticoid supplementation is of particular importance) Acute adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; mineralo…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 084282
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 Sodium Phosphate | Dexamethasone sodium phosphate 4 mg/mL | InjectionIntra-articular, Intralesional, Intramuscular, Intravenous, Soft tissue | Medical Purchasing Solutions, LLC | 71872-7164 |
| Dexamethasone Sodium Phosphate | Dexamethasone sodium phosphate 4 mg/mL | InjectionIntra-articular, Intralesional, Intramuscular, Intravenous, Soft tissue | Medical Purchasing Solutions, LLC | 71872-7171 |
| Dexamethasone Sodium Phosphate | Dexamethasone sodium phosphate 4 mg/mL | InjectionIntra-articular, Intralesional, Intramuscular, Intravenous, Soft tissue | Hikma Pharmaceuticals USA Inc. | 0641-6145 |
| Dexamethasone Sodium Phosphate | Dexamethasone sodium phosphate 4 mg/mL | InjectionIntra-articular, Intralesional, Intramuscular, Intravenous, Soft tissue | Henry Schein, Inc. | 0404-9805 |
| Dexamethasone Sodium Phosphate | Dexamethasone sodium phosphate 4 mg/mL | InjectionIntra-articular, Intralesional, Intramuscular, Intravenous, Soft tissue | HF Acquisition Co LLC, DBA HealthFirst | 51662-1297 |
| Dexamethasone Sodium Phosphate | Dexamethasone sodium phosphate 4 mg/mL | InjectionIntra-articular, Intralesional, Intramuscular, Intravenous, Soft tissue | Civica, Inc. | 72572-120 |
| Dexamethasone Sodium Phosphate | Dexamethasone sodium phosphate 4 mg/mL | InjectionIntra-articular, Intralesional, Intramuscular, Intravenous, Soft tissue | HF Acquisition Co LLC, DBA HealthFirst | 51662-1660 |
| Dexamethasone Sodium Phosphate | Dexamethasone sodium phosphate 4 mg/mL | InjectionIntra-articular, Intralesional, Intramuscular, Intravenous, Soft tissue | Asclemed USA, Inc. | 76420-555 |
| Dexamethasone Sodium Phosphate | Dexamethasone sodium phosphate 4 mg/mL | InjectionIntra-articular, Intralesional, Intramuscular, Intravenous, Soft tissue | ASCLEMED USA INC. | 87063-289 |
| Dexamethasone Sodium Phosphate | Dexamethasone sodium phosphate 4 mg/mL | InjectionIntra-articular, Intralesional, Intramuscular, Intravenous, Soft tissue | ASCLEMED USA INC. | 87063-290 |
| Dexamethasone Sodium Phosphate | Dexamethasone sodium phosphate 4 mg/mL | InjectionIntra-articular, Intralesional, Intramuscular, Intravenous, Soft tissue | REMEDYREPACK INC. | 70518-3724 |