Prescription drug · ANDA
Orphenadrine Citrate NDC 50090-0169
Orphenadrine citrate 100 mg/1 · Tablet, Extended release · Oral · A-S Medication Solutions
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50090-0169-0 | 50090016900 | 20 TABLET, EXTENDED RELEASE in 1 BOTTLE (50090-0169-0)Marketed from Jun 21, 2016 | |
| 50090-0169-1 | 50090016901 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (50090-0169-1)Marketed from Nov 28, 2014 | |
| 50090-0169-5 | 50090016905 | 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (50090-0169-5)Marketed from Nov 28, 2014 |
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)
- Orphenadrine Citrate
- Generic name (nonproprietary)
- orphenadrine citrate
- Active ingredients
- Orphenadrine citrate — 100 mg/1
- Dosage form
- Tablet, Extended release
- Route
- Oral
- Labeler
- A-S Medication Solutions
- 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 50090-0169_a11270c6-fe5e-4cfd-9a1e-f11abb0fe4a0SPL ID a11270c6-fe5e-4cfd-9a1e-f11abb0fe4a0SPL set ID 80ef7fb4-7c50-4d25-915e-f9d4a2ccd199RxCUI 994521UNII X0A40N8I4S
- 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
N450090016900followed by a unit qualifier and the quantityPackage 50090-0169-00. 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 .
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 | Proficient Rx LP | 63187-122 |
| 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 |