Prescription drug · ANDA
Dobutamine NDC 0409-2344
Dobutamine hydrochloride 12.5 mg/mL · Injection, Solution, Concentrate · Intravenous · Hospira, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0409-2344-01 | 00409234401 | 1 VIAL, SINGLE-DOSE in 1 CARTON (0409-2344-01) / 20 mL in 1 VIAL, SINGLE-DOSEMarketed from Aug 3, 2005 | |
| 0409-2344-02 | 00409234402 | 10 VIAL, SINGLE-DOSE in 1 TRAY (0409-2344-02) / 20 mL in 1 VIAL, SINGLE-DOSE (0409-2344-62)Marketed from Jun 29, 2005 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
- Dobutamine
- Generic name (nonproprietary)
- dobutamine
- Active ingredients
- Dobutamine hydrochloride — 12.5 mg/mL
- Dosage form
- Injection, Solution, Concentrate
- Route
- Intravenous
- Labeler
- Hospira, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 074086
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic beta-Agonists (Mechanism)
- Identifiers
- Product ID 0409-2344_e71e9520-871b-479d-9652-1857fceca863SPL ID e71e9520-871b-479d-9652-1857fceca863SPL set ID dc537761-d5f4-488d-24ab-b2bcd2b17b7aRxCUI 1812168UNII 0WR771DJXV
- 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
N400409234401followed by a unit qualifier and the quantityPackage 00409-2344-01. 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)
INDICATIONS AND USAGE Dobutamine Injection, USP is indicated when parenteral therapy is necessary for inotropic support in the short-term treatment of adults with cardiac decompensation due to depressed contractility resulting either from organic heart disease or from cardiac surgical procedures. In patients who have atrial fibrillation with rapid ventricular response, a digitalis preparation should be used prior to institution of therapy with dobutamine hydrochloride.
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 074086
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 |
|---|---|---|---|---|
| Dobutamine | Dobutamine hydrochloride 12.5 mg/mL | Injection, Solution, ConcentrateIntravenous | HF Acquisition Co LLC, DBA HealthFirst | 51662-1337 |