Prescription drug · NDA
Dobutamine Hydrochloride NDC 51662-1566
Dobutamine hydrochloride 100 mg/100mL · Injection · Intravenous · HF Acquisition Co LLC, DBA HealthFirst
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 51662-1566-1 | 51662156601 | 250 mL in 1 BAG (51662-1566-1)Marketed from Jul 10, 2021 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 Hydrochloride
- Generic name (nonproprietary)
- dobutamine hydrochloride
- Active ingredients
- Dobutamine hydrochloride — 100 mg/100mL
- Dosage form
- Injection
- Route
- Intravenous
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 020255
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic beta-Agonists (Mechanism)
- Identifiers
- Product ID 51662-1566_1035c14e-d1ea-8603-e063-6394a90a430bSPL ID 1035c14e-d1ea-8603-e063-6394a90a430bSPL set ID c6ceb8d3-e46e-f0da-e053-2995a90a8c3cRxCUI 309985UNII 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
N451662156601followed by a unit qualifier and the quantityPackage 51662-1566-01. 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 & USAGE Dobutamine Hydrochloride in 5% Dextrose Injection is indicated when parenteral therapy is necessary for inotropic support in the short-term treatment of patients with cardiac decompensation due to depressed contractility resulting either from organic heart disease or from cardiac surgical procedures. Experience with intravenous dobutamine in controlled trials does not extend beyond 48 hours of repeated boluses and/or continuous infusions. Whether given orally, continuously intravenously, or intermittently intravenously, neither dobutamine nor any other cyclic-AMP-dependent inotrope has been shown in controlled trials to be safe or effective in the long-term treatment of c…
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 020255
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 Hydrochloride in Dextrosedobutamine hydrochloride | Dobutamine hydrochloride 100 mg/100mL | InjectionIntravenous | Baxter Healthcare Corporation | 0338-1073 |
| Dobutamine Hydrochloride in Dextrosedobutamine hydrochloride | Dobutamine hydrochloride 200 mg/100mL | InjectionIntravenous | Baxter Healthcare Corporation | 0338-1075 |
| Dobutamine Hydrochloride in Dextrosedobutamine hydrochloride | Dobutamine hydrochloride 400 mg/100mL | InjectionIntravenous | Baxter Healthcare Corporation | 0338-1077 |