Prescription drug · ANDA
Dexamethasone Sodium Phosphate NDC 70069-025
Dexamethasone sodium phosphate 10 mg/mL · Injection, Solution · Intramuscular, Intravenous · Somerset Therapeutics, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70069-025-10 | 7006900251070069002510 | 10 VIAL in 1 CARTON (70069-025-10) / 10 mL in 1 VIALMarketed from Jun 11, 2019 |
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 Sodium Phosphate
- Generic name (nonproprietary)
- dexamethasone sodium phosphate
- Active ingredients
- Dexamethasone sodium phosphate — 10 mg/mL
- Dosage form
- Injection, Solution
- Route
- Intramuscular, Intravenous
- Labeler
- Somerset Therapeutics, LLCNDC labeler code 70069
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 211036
- Marketing start
- Listing expires
- Other FDA classes
- Corticosteroid Hormone Receptor Agonists (Mechanism)
- Identifiers
- Product ID 70069-025_0fefe630-0e29-4d04-a083-eb3036f48100SPL ID 0fefe630-0e29-4d04-a083-eb3036f48100SPL set ID 5a1b0266-90c8-4176-a6b0-c4204d3c604eRxCUI 309696UNII AI9376Y64PUPC 0370069025109, 0370069025017
- 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
N470069002510followed by a unit qualifier and the quantityPackage 70069-0025-10. 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 AND USAGE 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 choic…
Excerpt only. Read the full label for complete information.
About NDC 70069-025
- What is NDC 70069-025?
- 70069-025 is the product NDC for Dexamethasone Sodium Phosphate, Dexamethasone sodium phosphate 10 mg/mL injection, solution, listed with the FDA by Somerset Therapeutics, LLC. 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?
- Somerset Therapeutics, LLC, NDC labeler code 70069. 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 211036
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 | Injection, SolutionIntramuscular, Intravenous | Medical Purchasing Solutions, LLC | 71872-7205 |