Prescription drug · ANDA
Orphenadrine Citrate NDC 63187-122
Orphenadrine citrate 100 mg/1 · Tablet, Extended release · Oral · Proficient Rx LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63187-122-20 | 63187012220 | 20 TABLET, EXTENDED RELEASE in 1 BOTTLE (63187-122-20)Marketed from Feb 2, 2015 | |
| 63187-122-30 | 63187012230 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (63187-122-30)Marketed from Feb 2, 2015 | |
| 63187-122-60 | 63187012260 | 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (63187-122-60)Marketed from Feb 2, 2015 | |
| 63187-122-90 | 63187012290 | 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (63187-122-90)Marketed from Feb 2, 2015 |
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)
- Orphenadrine Citrate
- Generic name (nonproprietary)
- orphenadrine citrate
- Active ingredients
- Orphenadrine citrate — 100 mg/1
- Dosage form
- Tablet, Extended release
- Route
- Oral
- Labeler
- Proficient Rx LP
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 040284
- Marketing start
- Listing expires
- Other FDA classes
- Centrally-mediated Muscle Relaxation (Physiologic effect)
- Identifiers
- Product ID 63187-122_6733ab80-4fe3-4bdb-8e81-3beb50b5db0cSPL ID 6733ab80-4fe3-4bdb-8e81-3beb50b5db0cSPL set ID cf620257-7497-44c1-9853-87f96d262fbdRxCUI 994521UNII X0A40N8I4SUPC 0363187122300
- Pharmacologic class
- Muscle Relaxant
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
N463187012220followed by a unit qualifier and the quantityPackage 63187-0122-20. 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 AND USAGE Orphenadrine citrate extended-release tablets are indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute painful musculoskeletal conditions.
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 040284
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 |
|---|---|---|---|---|
| Orphenadrine Citrate | Orphenadrine citrate 100 mg/1 | Tablet, Extended releaseOral | NuCare Pharmaceuticals, Inc. | 66267-158 |
| Orphenadrine Citrate | Orphenadrine citrate 100 mg/1 | Tablet, Extended releaseOral | REMEDYREPACK INC. | 70518-4506 |
| Orphenadrine Citrate | Orphenadrine citrate 100 mg/1 | Tablet, Extended releaseOral | Northwind Health Company, LLC | 82868-040 |
| Orphenadrine Citrate | Orphenadrine citrate 100 mg/1 | Tablet, Extended releaseOral | Lake Erie Medical DBA Quality Care Products LLC | 49999-046 |
| Orphenadrine Citrate | Orphenadrine citrate 100 mg/1 | Tablet, Extended releaseOral | St. Mary's Medical Park Pharmacy | 60760-810 |
| Orphenadrine Citrate | Orphenadrine citrate 100 mg/1 | Tablet, Extended releaseOral | PD-Rx Pharmaceuticals, Inc. | 43063-407 |
| Orphenadrine Citrate | Orphenadrine citrate 100 mg/1 | Tablet, Extended releaseOral | Bryant Ranch Prepack | 63629-1564 |
| Orphenadrine Citrate | Orphenadrine citrate 100 mg/1 | Tablet, Extended releaseOral | Advanced Rx Pharmacy of Tennessee, LLC | 80425-0340 |
| Orphenadrine Citrate | Orphenadrine citrate 100 mg/1 | Tablet, Extended releaseOral | Preferred Pharmaceuticals, Inc. | 68788-9138 |
| Orphenadrine Citrate | Orphenadrine citrate 100 mg/1 | Tablet, Extended releaseOral | Bryant Ranch Prepack | 72162-2020 |
| Orphenadrine Citrate | Orphenadrine citrate 100 mg/1 | Tablet, Extended releaseOral | Lupin Pharmaceuticals, Inc. | 43386-480 |
| Orphenadrine Citrate ERorphenadrine citrate | Orphenadrine citrate 100 mg/1 | Tablet, Extended releaseOral | Advanced Rx Pharmacy of Tennessee, LLC | 80425-0117 |
| Orphenadrine Citrate | Orphenadrine citrate 100 mg/1 | Tablet, Extended releaseOral | A-S Medication Solutions | 50090-0169 |