Prescription drug · ANDA
Dexamethasone Sodium Phosphate NDC 76045-106
Dexamethasone sodium phosphate 4 mg/mL · Injection, Solution · Intra-articular, Intralesional, Intramuscular, Intravenous, Soft tissue · Fresenius Kabi USA, LLC
NDC codes
FDA NDC DirectoryProduct information
- Brand name (proprietary)
- Dexamethasone Sodium Phosphate
- Generic name (nonproprietary)
- dexamethasone sodium phosphate
- Active ingredients
- Dexamethasone sodium phosphate — 4 mg/mL
- Dosage form
- Injection, Solution
- Route
- Intra-articular, Intralesional, Intramuscular, Intravenous, Soft tissue
- Labeler
- Fresenius Kabi USA, LLCNDC labeler code 76045
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 203129
- Marketing start
- Listing expires
- Other FDA classes
- Corticosteroid Hormone Receptor Agonists (Mechanism)
- Identifiers
- Product ID 76045-106_f5934e17-4553-425b-b1bf-140cba479c36SPL ID f5934e17-4553-425b-b1bf-140cba479c36SPL set ID 88d25d19-acff-477b-86c8-9797782045b8RxCUI 1812095UNII 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.
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; minera…
Excerpt only. Read the full label for complete information.
About NDC 76045-106
- What is NDC 76045-106?
- 76045-106 is the product NDC for Dexamethasone Sodium Phosphate, Dexamethasone sodium phosphate 4 mg/mL injection, solution, listed with the FDA by Fresenius Kabi USA, LLC.
- What drug is associated with this NDC?
- Dexamethasone Sodium Phosphate.
- What is the active ingredient?
- Dexamethasone sodium phosphate.
- Who is the labeler?
- Fresenius Kabi USA, LLC, NDC labeler code 76045. 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 Sodium Phosphate?
- 94 other product NDCs are listed under this name. See all Dexamethasone Sodium Phosphate NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Dexamethasone Sodium Phosphate 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 Sodium Phosphate | Dexamethasone sodium phosphate 4 mg/mL | Injection, SolutionIntra-articular, Intralesional, Intramuscular, Intravenous, Soft tissue | REMEDYREPACK INC. | 70518-4372 | 70518-4372-00 |
| Dexamethasone Sodium Phosphate | Dexamethasone sodium phosphate 10 mg/mL | Injection, SolutionIntramuscular, Intravenous | Armas Pharmaceuticals | 72485-118 | 72485-0118-25 |
| Dexamethasone Sodium Phosphate | Dexamethasone sodium phosphate 4 mg/mL | Injection, SolutionIntra-articular, Intralesional, Intramuscular, Intravenous, Soft tissue | Henry Schein, Inc. | 0404-9795 | 00404-9795-30 |
| Dexamethasone Sodium Phosphate | Dexamethasone sodium phosphate 4 mg/mL | InjectionIntra-articular, Intralesional, Intramuscular, Intravenous, Soft tissue | Henry Schein, Inc. | 0404-9805 | 00404-9805-05 |
| Dexamethasone Sodium Phosphate | Dexamethasone sodium phosphate 4 mg/mL | Injection, SolutionIntra-articular, Intralesional, Intramuscular, Intravenous, Soft tissue | Medical Purchasing Solutions, LLC. | 71872-7347 | 71872-7347-01 |
| Dexamethasone Sodium Phosphate | Dexamethasone sodium phosphate 4 mg/mL | Injection, SolutionIntra-articular, Intralesional, Intramuscular, Intravenous, Soft tissue | Sagent Pharmaceuticals | 25021-052 | 25021-0052-0125021-0052-05 |
| Dexamethasone Sodium Phosphate | Dexamethasone sodium phosphate 10 mg/mL | Injection, SolutionIntra-articular, Intralesional, Intramuscular, Intravenous, Soft tissue | Sagent Pharmaceuticals | 25021-053 | 25021-0053-01 |
| Dexamethasone sodium phosphate | Dexamethasone sodium phosphate 10 mg/mL | Injection, SolutionIntramuscular, Intravenous | Micro Labs Limited | 42571-432 | 42571-0432-4042571-0432-79 |
| Dexamethasone Sodium Phosphate | Dexamethasone sodium phosphate 10 mg/mL | Injection, EmulsionIntramuscular, Intravenous | Fresenius Kabi USA, LLC | 76045-212 | 76045-0212-10 |
| Dexamethasone Sodium Phosphate | Dexamethasone sodium phosphate 10 mg/mL | InjectionIntra-articular, Intralesional, Intramuscular, Intravenous, Soft tissue | Gland Pharma Limited | 68083-607 | 68083-0607-25 |
Other NDCs under ANDA 203129
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 | Injection, SolutionIntra-articular, Intralesional, Intramuscular, Intravenous, Soft tissue | Fresenius Kabi USA, LLC | 76045-210 |