Prescription drug · ANDA
meloxicam NDC 68788-8758
Meloxicam 7.5 mg/1 · Tablet · Oral · Preferred Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68788-8758-0 | 68788875800 | 100 TABLET in 1 BOTTLE (68788-8758-0)Marketed from Oct 17, 2024 | |
| 68788-8758-1 | 68788875801 | 15 TABLET in 1 BOTTLE (68788-8758-1)Marketed from Oct 17, 2024 | |
| 68788-8758-2 | 68788875802 | 20 TABLET in 1 BOTTLE (68788-8758-2)Marketed from Oct 17, 2024 | |
| 68788-8758-3 | 68788875803 | 30 TABLET in 1 BOTTLE (68788-8758-3)Marketed from Oct 17, 2024 | |
| 68788-8758-6 | 68788875806 | 60 TABLET in 1 BOTTLE (68788-8758-6)Marketed from Oct 17, 2024 | |
| 68788-8758-8 | 68788875808 | 28 TABLET in 1 BOTTLE (68788-8758-8)Marketed from Oct 17, 2024 | |
| 68788-8758-9 | 68788875809 | 90 TABLET in 1 BOTTLE (68788-8758-9)Marketed from Oct 17, 2024 |
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
- Preferred Pharmaceuticals Inc.NDC labeler code 68788
- 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 68788-8758_d4d2969c-6daf-468b-802c-1b77b5b66ddeSPL ID d4d2969c-6daf-468b-802c-1b77b5b66ddeSPL set ID c6f37980-8e09-4f2e-a768-b3d22cbe3d49RxCUI 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
N468788875800followed by a unit qualifier and the quantityPackage 68788-8758-00. 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)
Meloxicam tablets are a non-steroidal anti-inflammatory drug indicated for: • Osteoarthritis (OA) () • Rheumatoid Arthritis (RA) () • Juvenile Rheumatoid Arthritis (JRA) in patients who weigh ≥60 kg () 1.1 Osteoarthritis (OA) Meloxicam tablets are indicated for relief of the signs and symptoms of osteoarthritis [ see Clinical Studies ( ) ]. 1.2 Rheumatoid Arthritis (RA) Meloxicam tablets are indicated for relief of the signs and symptoms of rheumatoid arthritis [ see Clinical Studies ( ) ]. 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 Rheu…
Excerpt only. Read the full label for complete information.
About NDC 68788-8758
- What is NDC 68788-8758?
- 68788-8758 is the product NDC for meloxicam, Meloxicam 7.5 mg/1 tablet, listed with the FDA by Preferred Pharmaceuticals Inc.. It has 7 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?
- Preferred Pharmaceuticals Inc., NDC labeler code 68788. 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 7.5 mg/1 | TabletOral | QPharma, Inc. | 42708-093 |
| Meloxicam | Meloxicam 7.5 mg/1 | TabletOral | Exelan Pharmaceuticals Inc. | 76282-152 |
| meloxicam | Meloxicam 7.5 mg/1 | TabletOral | Coupler LLC | 67046-1342 |
| Meloxicam | Meloxicam 15 mg/1 | TabletOral | Exelan Pharmaceuticals Inc. | 76282-153 |
| meloxicam | Meloxicam 15 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-0394 |
| meloxicam | Meloxicam 15 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-3328 |
| meloxicam | Meloxicam 15 mg/1 | TabletOral | Sportpharm LLC | 85766-036 |
| meloxicam | Meloxicam 15 mg/1 | TabletOral | NuCare Pharmaceuticals, Inc. | 68071-1993 |
| meloxicam | Meloxicam 7.5 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-1994 |
| 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 | PHOENIX RX LLC | 85509-1124 |
| meloxicam | Meloxicam 15 mg/1 | TabletOral | PHOENIX RX LLC | 85509-1125 |
| meloxicam | Meloxicam 15 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-8801 |
| Meloxicam | Meloxicam 15 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-544 |
| meloxicam | Meloxicam 7.5 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-0406 |
| meloxicam | Meloxicam 15 mg/1 | TabletOral | Northwind Health Company, LLC | 51655-577 |
| Meloxicam | Meloxicam 7.5 mg/1 | TabletOral | Advanced Rx of Tennessee, LLC | 80425-0041 |
| 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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