Prescription drug · ANDA
adenosine NDC 72078-033
Adenosine 3 mg/mL · Injection · Intravenous · Mylan Institutional LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72078-033-02 | 72078003302 | 10 VIAL, SINGLE-DOSE in 1 CARTON (72078-033-02) / 2 mL in 1 VIAL, SINGLE-DOSE (72078-033-00)Marketed from Apr 6, 2022 |
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)
- adenosine
- Generic name (nonproprietary)
- adenosine
- Active ingredients
- Adenosine — 3 mg/mL
- Dosage form
- Injection
- Route
- Intravenous
- Labeler
- Mylan Institutional LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 078686
- Marketing start
- Listing expires
- Other FDA classes
- Adenosine Receptor Agonists (Mechanism)
- Identifiers
- Product ID 72078-033_c1c149fe-9095-4b2a-a21f-7af3212e0254SPL ID c1c149fe-9095-4b2a-a21f-7af3212e0254SPL set ID c1c149fe-9095-4b2a-a21f-7af3212e0254RxCUI 1654169UNII K72T3FS567UPC 0372078033021
- Pharmacologic class
- Adenosine Receptor 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
N472078003302followed by a unit qualifier and the quantityPackage 72078-0033-02. 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 Intravenous adenosine injection is indicated for the following: Conversion to sinus rhythm of paroxysmal supraventricular tachycardia (PSVT), including that associated with accessory bypass tracts (Wolff-Parkinson-White Syndrome). When clinically advisable, appropriate vagal maneuvers (e.g., Valsalva maneuver), should be attempted prior to adenosine administration. It is important to be sure the adenosine injection solution actually reaches the systemic circulation (see Dosage and Administration ). Adenosine injection does not convert atrial flutter, atrial fibrillation, or ventricular tachycardia to normal sinus rhythm. In the presence of atrial flutter or atrial fibri…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 078686
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 |
|---|---|---|---|---|
| adenosine | Adenosine 3 mg/mL | InjectionIntravenous | Medical Purchasing Solutions, LLC | 71872-7209 |
| Adenosine | Adenosine 3 mg/mL | InjectionIntravenous | HF Acquisition Co LLC, DBA HealthFirst | 51662-1631 |
| adenosine | Adenosine 3 mg/mL | InjectionIntravenous | Mylan Institutional LLC | 67457-854 |
| adenosine | Adenosine 3 mg/mL | InjectionIntravenous | Mylan Institutional LLC | 67457-855 |