Prescription drug · ANDA
Adenosine NDC 63323-651
Adenosine 3 mg/mL · Injection, Solution · Intravenous · Fresenius Kabi USA, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63323-651-89 | 6332306518963323065189 | 10 SYRINGE, PLASTIC in 1 CARTON (63323-651-89) / 2 mL in 1 SYRINGE, PLASTIC (63323-651-21)Marketed from Apr 16, 2018 | |
| 63323-651-90 | 6332306519063323065190 | 10 SYRINGE, PLASTIC in 1 CARTON (63323-651-90) / 4 mL in 1 SYRINGE, PLASTIC (63323-651-23)Marketed from Apr 16, 2018 |
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, Solution
- Route
- Intravenous
- Labeler
- Fresenius Kabi USA, LLCNDC labeler code 63323
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 205568
- Marketing start
- Listing expires
- Other FDA classes
- Adenosine Receptor Agonists (Mechanism)
- Identifiers
- Product ID 63323-651_5af5d3b5-1a03-4717-b828-97589f278992SPL ID 5af5d3b5-1a03-4717-b828-97589f278992SPL set ID 6785cf30-360f-409b-a4b2-fc910728f01fRxCUI 727355, 727360UNII K72T3FS567
- 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
N463323065189followed by a unit qualifier and the quantityPackage 63323-0651-89. 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, USP 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 injection, USP administration. It is important to be sure the adenosine injection, USP solution actually reaches the systemic circulation (see DOSAGE AND ADMINISTRATION ). Adenosine injection, USP does not convert atrial flutter, atrial fibrillation, or ventricular tachycardia to normal sinus rhythm. In the presence of…
Excerpt only. Read the full label for complete information.
About NDC 63323-651
- What is NDC 63323-651?
- 63323-651 is the product NDC for Adenosine, Adenosine 3 mg/mL injection, solution, listed with the FDA by Fresenius Kabi USA, LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Adenosine.
- What is the active ingredient?
- Adenosine.
- Who is the labeler?
- Fresenius Kabi USA, LLC, NDC labeler code 63323. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Adenosine?
- 28 other product NDCs are listed under this name. See all Adenosine NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Adenosine products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Adenosine | Adenosine 3 mg/mL | Injection, SolutionIntravenous | Meitheal Pharmaceuticals Inc. | 71288-207 | 71288-0207-21 |
| Adenosine | Adenosine 3 mg/mL | Injection, SolutionIntravenous | Meitheal Pharmaceuticals Inc. | 71288-208 | 71288-0208-30 |
| Adenosine | Adenosine 3 mg/mL | InjectionIntravenous | REMEDYREPACK INC. | 70518-4207 | 70518-4207-0070518-4207-02 |
| Adenosineadenosine injection, solution | Adenosine 3 mg/mL | Injection, SolutionIntravenous | Henry Schein, Inc. | 0404-9993 | 00404-9993-02 |
| Adenosine | Adenosine 3 mg/mL | Injection, SolutionIntravenous | HF Acquisition Co LLC, DBA HealthFirst | 51662-1632 | 51662-1632-01 |
| Adenosine | Adenosine 3 mg/mL | InjectionIntravenous | HF Acquisition Co LLC, DBA HealthFirst | 51662-1631 | 51662-1631-01 |
| Adenosine | Adenosine 3 mg/mL | InjectionIntravenous | Sagent Pharmaceuticals | 25021-318 | 25021-0318-0225021-0318-04 |
| Adenosine | Adenosine 3 mg/mL | InjectionIntravenous | Medical Purchasing Solutions, LLC | 71872-7335 | 71872-7335-01 |
| Adenosine | Adenosine 3 mg/mL | InjectionIntravenous | ProPharma Distribution | 84549-318 | 84549-0318-02 |
| Adenosine | Adenosine 3 mg/mL | Injection, SolutionIntravenous | NorthStar Rx LLC | 16714-556 | 16714-0556-01 |
Other NDCs under ANDA 205568
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 | Injection, SolutionIntravenous | HF Acquisition Co LLC, DBA HealthFirst | 51662-1643 |