Prescription drug · ANDA
Dobutamine NDC 0143-9141
Dobutamine hydrochloride 12.5 mg/mL · Injection, Solution · Intravenous · Hikma Pharmaceuticals USA Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0143-9141-10 | 00143914110 | 10 VIAL in 1 CARTON (0143-9141-10) / 20 mL in 1 VIALMarketed from May 3, 2023 |
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
- Route
- Intravenous
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 074277
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic beta-Agonists (Mechanism)
- Identifiers
- Product ID 0143-9141_b0a40444-634c-4eb0-a861-fe9e21e02552SPL ID b0a40444-634c-4eb0-a861-fe9e21e02552SPL set ID 74ba9408-17d3-48ac-be0b-a4fee9e7a1a5RxCUI 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
N400143914110followed by a unit qualifier and the quantityPackage 00143-9141-10. 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 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 congestive heart failure. In controlle…
Excerpt only. Read the full label for complete information.