Prescription drug · ANDA
Meloxicam NDC 43063-396
Meloxicam 15 mg/1 · Tablet · Oral · PD-Rx Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 43063-396-07 | 43063039607 | 7 TABLET in 1 BOTTLE, PLASTIC (43063-396-07)Marketed from Apr 24, 2018 | |
| 43063-396-15 | 43063039615 | 15 TABLET in 1 BOTTLE, PLASTIC (43063-396-15)Marketed from Jan 29, 2014 | |
| 43063-396-60 | 43063039660 | 60 TABLET in 1 BOTTLE, PLASTIC (43063-396-60)Marketed from Jan 29, 2014 | |
| 43063-396-90 | 43063039690 | 90 TABLET in 1 BOTTLE, PLASTIC (43063-396-90)Marketed from Jan 29, 2014 | |
| 43063-396-95 | 43063039695 | 1000 TABLET in 1 BOTTLE, PLASTIC (43063-396-95)Marketed from Dec 17, 2021 |
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)
- Meloxicam
- Generic name (nonproprietary)
- meloxicam
- Active ingredients
- Meloxicam — 15 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- PD-Rx Pharmaceuticals, Inc.NDC labeler code 43063
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 077918
- Marketing start
- Listing expires
- Other FDA classes
- Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
- Identifiers
- Product ID 43063-396_509b1803-4d56-85ab-e063-6294a90aecf3SPL ID 509b1803-4d56-85ab-e063-6294a90aecf3SPL set ID eae60d2c-411c-460a-b673-05b5784ed943RxCUI 152695UNII VG2QF83CGLUPC 0343063396957
- 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
N443063039607followed by a unit qualifier and the quantityPackage 43063-0396-07. 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 is a non-steroidal anti-inflammatory drug indicated for: Osteoarthritis (OA) ( 1.1 ) Rheumatoid Arthritis (RA) ( 1.2 ) Juvenile Rheumatoid Arthritis (JRA) in patients who weigh ≥60 kg ( 1.3 ) 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 Juv…
Excerpt only. Read the full label for complete information.
About NDC 43063-396
- What is NDC 43063-396?
- 43063-396 is the product NDC for Meloxicam, Meloxicam 15 mg/1 tablet, listed with the FDA by PD-Rx Pharmaceuticals, Inc.. It has 5 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?
- PD-Rx Pharmaceuticals, Inc., NDC labeler code 43063. 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 077918
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 | PD-Rx Pharmaceuticals, Inc. | 43063-395 |
| Meloxicam | Meloxicam 15 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 43353-979 |
| Meloxicam | Meloxicam 7.5 mg/1 | TabletOral | AvPAK | 50268-525 |
| Meloxicam | Meloxicam 15 mg/1 | TabletOral | AvPAK | 50268-526 |
| Meloxicam | Meloxicam 7.5 mg/1 | TabletOral | Golden State Medical Supply, Inc. | 51407-610 |
| Meloxicam | Meloxicam 15 mg/1 | TabletOral | Golden State Medical Supply, Inc. | 51407-611 |
| Meloxicam | Meloxicam 7.5 mg/1 | TabletOral | Carlsbad Technology, Inc. | 61442-126 |
| Meloxicam | Meloxicam 15 mg/1 | TabletOral | Carlsbad Technology, Inc. | 61442-127 |
| Meloxicam | Meloxicam 15 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-2019 |
| Meloxicam | Meloxicam 7.5 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-3248 |
| Meloxicam | Meloxicam 7.5 mg/1 | TabletOral | Proficient Rx LP | 71205-923 |
| Meloxicam | Meloxicam 15 mg/1 | TabletOral | Proficient Rx LP | 71205-924 |
| Meloxicam | Meloxicam 15 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-1888 |
| Meloxicam | Meloxicam 15 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-542 |
| Meloxicam | Meloxicam 15 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-657 |
| Meloxicam | Meloxicam 15 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-1738 |