Prescription drug · ANDA
Dexamethasone sodium phosphate NDC 42571-432
Dexamethasone sodium phosphate 10 mg/mL · Injection, Solution · Intramuscular, Intravenous · Micro Labs Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 42571-432-40 | 42571043240 | 1 VIAL in 1 CARTON (42571-432-40) / 1 mL in 1 VIAL (42571-432-54)Marketed from Aug 1, 2026 | |
| 42571-432-79 | 42571043279 | 25 VIAL in 1 CARTON (42571-432-79) / 1 mL in 1 VIAL (42571-432-54)Marketed from Jun 1, 2024 |
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
- Micro Labs Limited
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 217797
- Marketing start
- Listing expires
- Other FDA classes
- Corticosteroid Hormone Receptor Agonists (Mechanism)
- Identifiers
- Product ID 42571-432_59edca15-21cd-df4f-e063-6394a90a36dbSPL ID 59edca15-21cd-df4f-e063-6394a90a36dbSPL set ID c6f2563b-5a39-48bf-bcfe-71dd417bd970RxCUI 1812079UNII AI9376Y64PUPC 0342571432799, 0342571432546
- 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
N442571043240followed by a unit qualifier and the quantityPackage 42571-0432-40. 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; mine…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 217797
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 | Armas Pharmaceuticals | 72485-118 |