Prescription drug · ANDA
isoproterenol hydrochloride NDC 68083-585
Isoproterenol hydrochloride .2 mg/mL · Injection, Solution · Intravenous · Gland Pharma Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68083-585-25 | 68083058525 | 25 VIAL in 1 CARTON (68083-585-25) / 1 mL in 1 VIALMarketed from Oct 3, 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)
- isoproterenol hydrochloride
- Generic name (nonproprietary)
- isoproterenol hydrochloride
- Active ingredients
- Isoproterenol hydrochloride — .2 mg/mL
- Dosage form
- Injection, Solution
- Route
- Intravenous
- Labeler
- Gland Pharma Limited
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 217648
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic beta-Agonists (Mechanism)
- Identifiers
- Product ID 68083-585_a5d2e484-b959-4eef-9988-290ea1668c61SPL ID a5d2e484-b959-4eef-9988-290ea1668c61SPL set ID 2581854e-e654-4ac3-98e8-36c9f27748bfRxCUI 1667909, 1667915UNII DIA2A74855
- Pharmacologic class
- beta-Adrenergic Agonist
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
N468083058525followed by a unit qualifier and the quantityPackage 68083-0585-25. 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
Label details couldn’t be retrieved right now. Open the label on DailyMed.
Other NDCs under ANDA 217648
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 |
|---|---|---|---|---|
| Isoproterenol Hydrochloride | Isoproterenol hydrochloride .2 mg/mL | Injection, SolutionIntravenous | Sagent Pharmaceuticals | 25021-324 |
| isoproterenol hydrochloride | Isoproterenol hydrochloride 1 mg/5mL | Injection, SolutionIntravenous | Gland Pharma Limited | 68083-586 |