Prescription drug · ANDA
Dexamethasone Sodium Phosphate NDC 0641-0367
Dexamethasone sodium phosphate 10 mg/mL · Injection · Intramuscular, Intravenous · Hikma Pharmaceuticals USA Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0641-0367-25 | 0064103672500641036725 | 25 VIAL in 1 CARTON (0641-0367-25) / 1 mL in 1 VIAL (0641-0367-21)Marketed from Sep 7, 1982 |
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 — 10 mg/mL
- Dosage form
- Injection
- Route
- Intramuscular, Intravenous
- Labeler
- Hikma Pharmaceuticals USA Inc.NDC labeler code 0641
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 087702
- Marketing start
- Listing expires
- Other FDA classes
- Corticosteroid Hormone Receptor Agonists (Mechanism)
- Identifiers
- Product ID 0641-0367_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
N400641036725followed by a unit qualifier and the quantityPackage 00641-0367-25. 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.
About NDC 0641-0367
- What is NDC 0641-0367?
- 0641-0367 is the product NDC for Dexamethasone Sodium Phosphate, Dexamethasone sodium phosphate 10 mg/mL injection, listed with the FDA by Hikma Pharmaceuticals USA Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Dexamethasone Sodium Phosphate.
- What is the active ingredient?
- Dexamethasone sodium phosphate.
- Who is the labeler?
- Hikma Pharmaceuticals USA Inc., NDC labeler code 0641. 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 087702
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 10 mg/mL | InjectionIntramuscular, Intravenous | A-S Medication Solutions | 50090-3541 |
| Dexamethasone Sodium Phosphate | Dexamethasone sodium phosphate 10 mg/mL | InjectionIntramuscular, Intravenous | HF Acquisition Co LLC, DBA HealthFirst | 51662-1343 |
| Dexamethasone Sodium Phosphate | Dexamethasone sodium phosphate 10 mg/mL | InjectionIntramuscular, Intravenous | Cardinal Health 107, LLC | 55154-5118 |
| Dexamethasone Sodium Phosphate | Dexamethasone sodium phosphate 10 mg/mL | InjectionIntramuscular, Intravenous | REMEDYREPACK INC. | 70518-0532 |
| Dexamethasone Sodium Phosphate | Dexamethasone sodium phosphate 10 mg/mL | InjectionIntramuscular, Intravenous | Medical Purchasing Solutions, LLC | 71872-7091 |
| Dexamethasone Sodium Phosphate | Dexamethasone sodium phosphate 10 mg/mL | InjectionIntramuscular, Intravenous | Civica, Inc. | 72572-122 |