Prescription drug · ANDA
Adenosine NDC 68083-101
Adenosine 3 mg/mL · Injection · Intravenous · Gland Pharma Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68083-101-01 | 68083010101 | 10 SYRINGE in 1 CARTON (68083-101-01) / 2 mL in 1 SYRINGEMarketed from Apr 1, 2013 | |
| 68083-101-02 | 68083010102 | 10 SYRINGE in 1 CARTON (68083-101-02) / 4 mL in 1 SYRINGEMarketed from Apr 1, 2013 |
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
- Gland Pharma LimitedNDC labeler code 68083
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 077283
- Marketing start
- Listing expires
- Other FDA classes
- Adenosine Receptor Agonists (Mechanism)
- Identifiers
- Product ID 68083-101_e47b17c4-e913-43cf-8406-c38e16f5ae36SPL ID e47b17c4-e913-43cf-8406-c38e16f5ae36SPL set ID ab2edabd-e57d-4754-9822-93bd17af9e88RxCUI 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
N468083010101followed by a unit qualifier and the quantityPackage 68083-0101-01. 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 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 administration. It is important to be sure the adenosine solution actually reaches the systemic circulation (see DOSAGE AND ADMINISTRATION ). Adenosine does not convert atrial flutter, atrial fibrillation, or ventricular tachycardia to normal sinus rhythm. In the presence of atrial flutter or atrial fibrillation, a transient modest s…
Excerpt only. Read the full label for complete information.
About NDC 68083-101
- What is NDC 68083-101?
- 68083-101 is the product NDC for Adenosine, Adenosine 3 mg/mL injection, listed with the FDA by Gland Pharma Limited. 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?
- Gland Pharma Limited, NDC labeler code 68083. 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 077283
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 | Sagent Pharmaceuticals | 25021-301 |
| Adenosine | Adenosine 3 mg/mL | InjectionIntravenous | HF Acquisition Co LLC, DBA HealthFirst | 51662-1511 |
| adenosine | Adenosine 3 mg/mL | InjectionIntravenous | ProPharma Distribution | 84549-031 |