Prescription drug · NDA
Dobutamine Hydrochloride in Dextrose (Dobutamine hydrochloride) NDC 0338-1073
Dobutamine hydrochloride 100 mg/100mL · Injection · Intravenous · Baxter Healthcare Corporation
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0338-1073-02 | 0033810730200338107302 | 18 BAG in 1 CARTON (0338-1073-02) / 250 mL in 1 BAGMarketed from Sep 27, 1993 |
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 Hydrochloride in Dextrose
- Generic name (nonproprietary)
- dobutamine hydrochloride
- Active ingredients
- Dobutamine hydrochloride — 100 mg/100mL
- Dosage form
- Injection
- Route
- Intravenous
- Labeler
- Baxter Healthcare CorporationNDC labeler code 0338
- 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 0338-1073_34c787c1-46f7-4264-951d-c88a34dca533SPL ID 34c787c1-46f7-4264-951d-c88a34dca533SPL set ID 6b17b98b-e06d-42ed-925f-69aa2699deadRxCUI 309985, 309986, 309987UNII 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
N400338107302followed by a unit qualifier and the quantityPackage 00338-1073-02. 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 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…
Excerpt only. Read the full label for complete information.
About NDC 0338-1073
- What is NDC 0338-1073?
- 0338-1073 is the product NDC for Dobutamine Hydrochloride in Dextrose, Dobutamine hydrochloride 100 mg/100mL injection, listed with the FDA by Baxter Healthcare Corporation. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Dobutamine Hydrochloride in Dextrose (Dobutamine Hydrochloride).
- What is the active ingredient?
- Dobutamine hydrochloride.
- Who is the labeler?
- Baxter Healthcare Corporation, NDC labeler code 0338. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Dobutamine Hydrochloride in Dextrose?
- 2 other product NDCs are listed under this name. See all Dobutamine Hydrochloride in Dextrose NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Dobutamine Hydrochloride in Dextrose products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Dobutamine Hydrochloride in Dextrosedobutamine hydrochloride | Dobutamine hydrochloride 200 mg/100mL | InjectionIntravenous | Baxter Healthcare Corporation | 0338-1075 | 00338-1075-02 |
| Dobutamine Hydrochloride in Dextrosedobutamine hydrochloride | Dobutamine hydrochloride 400 mg/100mL | InjectionIntravenous | Baxter Healthcare Corporation | 0338-1077 | 00338-1077-02 |
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 | Dobutamine hydrochloride 100 mg/100mL | InjectionIntravenous | HF Acquisition Co LLC, DBA HealthFirst | 51662-1566 |
| 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 |