Prescription drug · ANDA
Isoproterenol Hydrochloride NDC 25021-324
Isoproterenol hydrochloride .2 mg/mL · Injection, Solution · Intravenous · Sagent Pharmaceuticals
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 25021-324-01 | 2502103240125021032401 | 10 VIAL in 1 CARTON (25021-324-01) / 1 mL in 1 VIALMarketed from Jan 15, 2025 | |
| 25021-324-05 | 2502103240525021032405 | 10 VIAL in 1 CARTON (25021-324-05) / 5 mL in 1 VIALMarketed from Jan 15, 2025 |
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
- Sagent PharmaceuticalsNDC labeler code 25021
- 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 25021-324_ad9afa40-406c-408e-ad98-520674d3acfaSPL ID ad9afa40-406c-408e-ad98-520674d3acfaSPL set ID d2a9b767-0274-49bf-83cd-2fcce9bedc78RxCUI 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
N425021032401followed by a unit qualifier and the quantityPackage 25021-0324-01. 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)
Isoproterenol Hydrochloride Injection is indicated: To improve hemodynamic status in patients in distributive shock and shock due to reduced cardiac output For bronchospasm occurring during anesthesia Isoproterenol Hydrochloride Injection is a beta-adrenergic agonist indicated: To improve hemodynamic status in patients in distributive shock and shock due to reduced cardiac output ( 1 ) For treatment of bronchospasm occurring during anesthesia ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 25021-324
- What is NDC 25021-324?
- 25021-324 is the product NDC for Isoproterenol Hydrochloride, Isoproterenol hydrochloride .2 mg/mL injection, solution, listed with the FDA by Sagent Pharmaceuticals. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Isoproterenol Hydrochloride.
- What is the active ingredient?
- Isoproterenol hydrochloride.
- Who is the labeler?
- Sagent Pharmaceuticals, NDC labeler code 25021. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Isoproterenol Hydrochloride?
- 19 other product NDCs are listed under this name. See all Isoproterenol Hydrochloride NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Isoproterenol Hydrochloride products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| isoproterenol hydrochloride | Isoproterenol hydrochloride .2 mg/mL | Injection, SolutionIntravenous | Gland Pharma Limited | 68083-585 | 68083-0585-25 |
| isoproterenol hydrochloride | Isoproterenol hydrochloride 1 mg/5mL | Injection, SolutionIntravenous | Gland Pharma Limited | 68083-586 | 68083-0586-10 |
| Isoproterenol Hydrochloride | Isoproterenol hydrochloride .2 mg/mL | Injection, SolutionIntracardiac, Intramuscular, Intravenous, Subcutaneous | Nordic Pharma, Inc. | 69918-731 | 69918-0731-11 |
| Isoproterenol Hydrochloride | Isoproterenol hydrochloride .2 mg/mL | Injection, SolutionIntravenous | Avenacy, Inc. | 83634-303 | 83634-0303-0183634-0303-05 |
| Isoproterenol hydrochloride | Isoproterenol hydrochloride .2 mg/mL | Injection, SolutionIntravenous | KVK-Tech, Inc. | 10702-364 | 10702-0364-51 |
| Isoproterenol Hydrochloride | Isoproterenol hydrochloride .2 mg/mL | Injection, SolutionIntravenous | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-660 | 23155-0660-4123155-0660-4223155-0660-43 |
| Isoproterenol Hydrochloride | Isoproterenol hydrochloride .2 mg/mL | Injection, SolutionIntravenous | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-661 | 23155-0661-4123155-0661-42 |
| Isoproterenol Hydrochloride | Isoproterenol hydrochloride .2 mg/mL | InjectionIntracardiac, Intramuscular, Intravenous, Subcutaneous | Armas Pharmaceuticals Inc. | 72485-113 | 72485-0113-10 |
| Isoproterenol Hydrochloride | Isoproterenol hydrochloride .2 mg/mL | Injection, SolutionIntracardiac, Intramuscular, Intravenous, Subcutaneous | Nordic Pharma, Inc. | 69918-735 | 69918-0735-10 |
| Isoproterenol Hydrochloride | Isoproterenol hydrochloride .2 mg/mL | InjectionIntravenous | Micro Labs Limited | 42571-294 | 42571-0294-79 |
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 | Gland Pharma Limited | 68083-585 |
| isoproterenol hydrochloride | Isoproterenol hydrochloride 1 mg/5mL | Injection, SolutionIntravenous | Gland Pharma Limited | 68083-586 |