Prescription drug · ANDA
Meloxicam NDC 80425-0041
Meloxicam 7.5 mg/1 · Tablet · Oral · Advanced Rx of Tennessee, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 80425-0041-1 | 80425004101 | 30 TABLET in 1 BOTTLE (80425-0041-1)Marketed from Mar 7, 2007 | |
| 80425-0041-2 | 80425004102 | 60 TABLET in 1 BOTTLE (80425-0041-2)Marketed from Mar 7, 2007 | |
| 80425-0041-3 | 80425004103 | 90 TABLET in 1 BOTTLE (80425-0041-3)Marketed from Mar 7, 2007 | |
| 80425-0041-4 | 80425004104 | 6 TABLET in 1 BOTTLE (80425-0041-4)Marketed from Mar 7, 2007 |
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 — 7.5 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 077927
- Marketing start
- Listing expires
- Other FDA classes
- Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
- Identifiers
- Product ID 80425-0041_4ceff67f-3d7e-b947-e063-6394a90a83e4SPL ID 4ceff67f-3d7e-b947-e063-6394a90a83e4SPL set ID af9ce58c-3cd7-769f-e053-2a95a90a5385RxCUI 311486UNII 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
N480425004101followed by a unit qualifier and the quantityPackage 80425-0041-01. 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 1.1 Osteoarthritis (OA) Meloxicam tablets are indicated for relief of the signs and symptoms of osteoarthritis [see Clinical Studies (14.1)]. 1.2 Rheumatoid Arthritis (RA) Meloxicam tablets are 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 tablets are indicated for relief of the signs and symptoms of pauciarticular or polyarticular course Juvenile Rheumatoid Arthritis in patients who weigh ≥60 kg [see Dosage and Administration (2.4) and Clinical Studies (14.2)].
Excerpt only. Read the full label for complete information.
About NDC 80425-0041
- What is NDC 80425-0041?
- 80425-0041 is the product NDC for Meloxicam, Meloxicam 7.5 mg/1 tablet, listed with the FDA by Advanced Rx of Tennessee, LLC. It has 4 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?
- 148 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 077927
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 15 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-0394 |
| meloxicam | Meloxicam 7.5 mg/1 | TabletOral | HAWAII REPACK, INC. | 85534-0019 |
| meloxicam | Meloxicam 15 mg/1 | TabletOral | HAWAII REPACK, INC. | 85534-0020 |
| meloxicam | Meloxicam 7.5 mg/1 | TabletOral | Coupler LLC | 67046-1342 |
| meloxicam | Meloxicam 7.5 mg/1 | TabletOral | QPharma, Inc. | 42708-093 |
| meloxicam | Meloxicam 7.5 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-8758 |
| Meloxicam | Meloxicam 15 mg/1 | TabletOral | Exelan Pharmaceuticals Inc. | 76282-153 |
| Meloxicam | Meloxicam 7.5 mg/1 | TabletOral | Exelan Pharmaceuticals Inc. | 76282-152 |
| meloxicam | Meloxicam 7.5 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-1994 |
| meloxicam | Meloxicam 15 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-8801 |
| meloxicam | Meloxicam 15 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-3328 |
| meloxicam | Meloxicam 7.5 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-0406 |
| Meloxicam | Meloxicam 15 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-544 |
| meloxicam | Meloxicam 7.5 mg/1 | TabletOral | Unichem Pharmaceuticals (USA), Inc. | 29300-124 |
| meloxicam | Meloxicam 15 mg/1 | TabletOral | Unichem Pharmaceuticals (USA), Inc. | 29300-125 |
| Meloxicam | Meloxicam 7.5 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-583 |
| meloxicam | Meloxicam 15 mg/1 | TabletOral | Northwind Health Company, LLC | 51655-577 |
| meloxicam | Meloxicam 15 mg/1 | TabletOral | Sportpharm LLC | 85766-036 |
| meloxicam | Meloxicam 15 mg/1 | TabletOral | Asclemed USA, Inc. | 76420-039 |
| Meloxicam | Meloxicam 15 mg/1 | TabletOral | Advanced Rx of Tennessee, LLC | 80425-0044 |
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