Prescription drug · ANDA
Isoproterenol (Isoproterenol hydrochloride) NDC 69097-521
Isoproterenol hydrochloride .2 mg/mL · Injection, Solution · Intracardiac, Intramuscular, Intravenous, Subcutaneous · Cipla USA Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69097-521-31 | 6909705213169097052131 | 25 AMPULE in 1 CARTON (69097-521-31) / 1 mL in 1 AMPULEMarketed from Jun 26, 2018 |
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
- Generic name (nonproprietary)
- isoproterenol hydrochloride
- Active ingredients
- Isoproterenol hydrochloride — .2 mg/mL
- Dosage form
- Injection, Solution
- Route
- Intracardiac, Intramuscular, Intravenous, Subcutaneous
- Labeler
- Cipla USA Inc.NDC labeler code 69097
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 210322
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic beta-Agonists (Mechanism)
- Identifiers
- Product ID 69097-521_6014b0c8-2851-4111-a4f7-6764be850176SPL ID 6014b0c8-2851-4111-a4f7-6764be850176SPL set ID f724120d-da28-4065-9e05-d7dd6afbb546RxCUI 1667909, 1667915UNII DIA2A74855UPC 0369097521318, 0369097522353
- 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
N469097052131followed by a unit qualifier and the quantityPackage 69097-0521-31. 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 69097-521
- What is NDC 69097-521?
- 69097-521 is the product NDC for Isoproterenol (isoproterenol hydrochloride), Isoproterenol hydrochloride .2 mg/mL injection, solution, listed with the FDA by Cipla USA Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Isoproterenol (Isoproterenol hydrochloride).
- What is the active ingredient?
- Isoproterenol hydrochloride.
- Who is the labeler?
- Cipla USA Inc., NDC labeler code 69097. 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?
- 1 other product NDC are listed under this name. See all Isoproterenol NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Isoproterenol products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Isoproterenolisoproterenol hydrochloride | Isoproterenol hydrochloride 1 mg/5mL | Injection, SolutionIntracardiac, Intramuscular, Intravenous, Subcutaneous | Cipla USA Inc. | 69097-522 | 69097-0522-35 |
Other NDCs under ANDA 210322
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 |
|---|---|---|---|---|
| Isoproterenolisoproterenol hydrochloride | Isoproterenol hydrochloride 1 mg/5mL | Injection, SolutionIntracardiac, Intramuscular, Intravenous, Subcutaneous | Cipla USA Inc. | 69097-522 |