Prescription drug · ANDA
Isoproterenol Hydrochloride NDC 83634-303
Isoproterenol hydrochloride .2 mg/mL · Injection, Solution · Intravenous · Avenacy, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 83634-303-01 | 83634030301 | 10 VIAL, SINGLE-DOSE in 1 CARTON (83634-303-01) / 1 mL in 1 VIAL, SINGLE-DOSE (83634-303-41)Marketed from May 15, 2024 | |
| 83634-303-05 | 83634030305 | 10 VIAL, SINGLE-DOSE in 1 CARTON (83634-303-05) / 5 mL in 1 VIAL, SINGLE-DOSE (83634-303-42)Marketed from May 15, 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
- Avenacy, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 212189
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic beta-Agonists (Mechanism)
- Identifiers
- Product ID 83634-303_ded94bcc-5654-4017-b3e6-65f1226beca1SPL ID ded94bcc-5654-4017-b3e6-65f1226beca1SPL set ID 212af0f4-42c7-425d-8baf-9a2f594289a2RxCUI 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
N483634030301followed by a unit qualifier and the quantityPackage 83634-0303-01. 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.
Other NDCs under ANDA 212189
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 | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-660 |
| Isoproterenol Hydrochloride | Isoproterenol hydrochloride .2 mg/mL | Injection, SolutionIntravenous | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-661 |