Prescription drug · ANDA
Meloxicam NDC 80425-0083
Meloxicam 15 mg/1 · Tablet · Oral · Advanced Rx of Tennessee, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 80425-0083-1 | 8042500830180425008301 | 30 TABLET in 1 BOTTLE (80425-0083-1)Marketed from Jul 19, 2006 | |
| 80425-0083-2 | 8042500830280425008302 | 60 TABLET in 1 BOTTLE (80425-0083-2)Marketed from Jul 19, 2006 | |
| 80425-0083-3 | 8042500830380425008303 | 90 TABLET in 1 BOTTLE (80425-0083-3)Marketed from Jul 19, 2006 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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)
- Meloxicam
- Generic name (nonproprietary)
- meloxicam
- Active ingredients
- Meloxicam — 15 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Advanced Rx of Tennessee, LLCNDC labeler code 80425
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 077929
- Marketing start
- Listing expires
- Other FDA classes
- Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
- Identifiers
- Product ID 80425-0083_2a98ebb7-ca49-d2dd-e063-6294a90ac15cSPL ID 2a98ebb7-ca49-d2dd-e063-6294a90ac15cSPL set ID b33bf17a-3134-6f32-e053-2a95a90a261bRxCUI 152695UNII VG2QF83CGL
- Pharmacologic class
- Nonsteroidal Anti-inflammatory Drug
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 HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N480425008301followed by a unit qualifier and the quantityPackage 80425-0083-01. 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 . This label includes a boxed warning.
Indications (excerpt from the label)
1. Indications and Usage Section 1 INDICATIONS AND USAGE 1.1 Osteoarthritis (OA) Meloxicam is indicated for relief of the signs and symptoms of osteoarthritis [see Clinical Studies (14.1)]. 1.2 Rheumatoid Arthritis (RA) Meloxicam is indicated for relief of the signs and symptoms of rheumatoid arthritis [see Clinical Studies (14.1)]. 1.3 Juvenile Rheumatoid Arthritis (JRA) Pauciarticular and Polyarticular Course Meloxicam is indicated for relief of the signs and symptoms of pauciarticular or polyarticular course Juvenile Rheumatoid Arthritis in patients who weighs ≥ 60 kg [see Dosage and Administration (2.4) and Clinical Studies (14.2)].
Excerpt only. Read the full label for complete information.
About NDC 80425-0083
- What is NDC 80425-0083?
- 80425-0083 is the product NDC for Meloxicam, Meloxicam 15 mg/1 tablet, listed with the FDA by Advanced Rx of Tennessee, LLC. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Meloxicam.
- What is the active ingredient?
- Meloxicam.
- Who is the labeler?
- Advanced Rx of Tennessee, LLC, NDC labeler code 80425. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Meloxicam?
- 147 other product NDCs are listed under this name. See all Meloxicam NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Meloxicam products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Meloxicam | Meloxicam 7.5 mg/1 | TabletOral | Direct_Rx | 72189-683 | 72189-0683-3072189-0683-6072189-0683-72+1 more |
| Meloxicam | Meloxicam 15 mg/1 | TabletOral | Direct_Rx | 72189-684 | 72189-0684-30 |
| meloxicam | Meloxicam 7.5 mg/1 | TabletOral | Coupler LLC | 67046-1342 | 67046-1342-03 |
| Meloxicam | Meloxicam 15 mg/1 | TabletOral | Advanced Rx of Tennessee, LLC | 80425-0584 | 80425-0584-0180425-0584-0280425-0584-03 |
| Meloxicam | Meloxicam 15 mg/1 | TabletOral | Advanced Rx of Tennessee, LLC | 80425-0585 | 80425-0585-0180425-0585-0280425-0585-03 |
| Meloxicam | Meloxicam 15 mg/1 | TabletOral | Advanced Rx of Tennessee, LLC | 80425-0586 | 80425-0586-0180425-0586-0280425-0586-03 |
| meloxicam | Meloxicam 15 mg/1 | TabletOral | Coupler LLC | 67046-0891 | 67046-0891-03 |
| meloxicam | Meloxicam 7.5 mg/1 | TabletOral | Coupler LLC | 67046-0057 | 67046-0057-03 |
| Meloxicam | Meloxicam 7.5 mg/1 | TabletOral | Medcore LLC | 82461-719 | 82461-0719-30 |
| Meloxicam | Meloxicam 7.5 mg/1 | TabletOral | AiPing Pharmaceutical, Inc | 11788-046 | 11788-0046-0111788-0046-0511788-0046-10 |
Other NDCs under ANDA 077929
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 |
|---|---|---|---|---|
| Meloxicam | Meloxicam 7.5 mg/1 | TabletOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8040 |
| Meloxicam | Meloxicam 15 mg/1 | TabletOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8124 |
| Meloxicam | Meloxicam 15 mg/1 | TabletOral | A-S Medication Solutions | 50090-6671 |
| Meloxicam | Meloxicam 15 mg/1 | TabletOral | A-S Medication Solutions | 50090-6672 |
| Meloxicam | Meloxicam 7.5 mg/1 | TabletOral | A-S Medication Solutions | 50090-6803 |
| Meloxicam | Meloxicam 7.5 mg/1 | TabletOral | A-S Medication Solutions | 50090-7875 |
| Meloxicam | Meloxicam 7.5 mg/1 | TabletOral | Northwind Health Company, LLC | 51655-177 |
| Meloxicam | Meloxicam 15 mg/1 | TabletOral | Northwind Health Company, LLC | 51655-571 |
| Meloxicam | Meloxicam 15 mg/1 | TabletOral | St. Mary's Medical Park Pharmacy | 60760-653 |
| Meloxicam | Meloxicam 15 mg/1 | TabletOral | Redpharm Drug | 67296-1317 |
| Meloxicam | Meloxicam 15 mg/1 | TabletOral | NuCare Pharmaceuticals, Inc. | 68071-2184 |
| Meloxicam | Meloxicam 7.5 mg/1 | TabletOral | Cipla USA Inc. | 69097-158 |
| Meloxicam | Meloxicam 15 mg/1 | TabletOral | Cipla USA Inc. | 69097-159 |
| Meloxicam | Meloxicam 15 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-0200 |
| Meloxicam | Meloxicam 15 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-1630 |
| Meloxicam | Meloxicam 7.5 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-2631 |
| Meloxicam | Meloxicam 15 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2327 |
| Meloxicam | Meloxicam 7.5 mg/1 | TabletOral | Asclemed USA, Inc. | 76420-325 |
| Meloxicam | Meloxicam 15 mg/1 | TabletOral | Asclemed USA, Inc. | 76420-326 |
| Meloxicam | Meloxicam 7.5 mg/1 | TabletOral | Advanced Rx of Tennessee, LLC | 80425-0043 |
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