Prescription drug · ANDA
Orphenadrine Citrate ER (Orphenadrine citrate) NDC 80425-0117
Orphenadrine citrate 100 mg/1 · Tablet, Extended release · Oral · Advanced Rx Pharmacy of Tennessee, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 80425-0117-1 | 8042501170180425011701 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (80425-0117-1)Marketed from Jun 19, 1998 | |
| 80425-0117-2 | 8042501170280425011702 | 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (80425-0117-2)Marketed from Aug 17, 2023 |
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 ERSuffix: ER
- Generic name (nonproprietary)
- orphenadrine citrate
- Active ingredients
- Orphenadrine citrate — 100 mg/1
- Dosage form
- Tablet, Extended release
- Route
- Oral
- Labeler
- Advanced Rx Pharmacy of Tennessee, LLCNDC labeler code 80425
- 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 80425-0117_2a996b2b-b5dc-65e7-e063-6394a90adeedSPL ID 2a996b2b-b5dc-65e7-e063-6394a90adeedSPL set ID b5a6846a-ebb3-1fdd-e053-2a95a90a4130RxCUI 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
N480425011701followed by a unit qualifier and the quantityPackage 80425-0117-01. 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 .
Indications (excerpt from the label)
3. Indications and Usage Section 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.
About NDC 80425-0117
- What is NDC 80425-0117?
- 80425-0117 is the product NDC for Orphenadrine Citrate ER (orphenadrine citrate), Orphenadrine citrate 100 mg/1 tablet, extended release, listed with the FDA by Advanced Rx Pharmacy of Tennessee, LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Orphenadrine Citrate ER (Orphenadrine Citrate).
- What is the active ingredient?
- Orphenadrine citrate.
- Who is the labeler?
- Advanced Rx Pharmacy 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 Orphenadrine Citrate ER?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
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 | PD-Rx Pharmaceuticals, Inc. | 43063-407 |
| Orphenadrine Citrate | Orphenadrine citrate 100 mg/1 | Tablet, Extended releaseOral | Lupin Pharmaceuticals, Inc. | 43386-480 |
| 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 | A-S Medication Solutions | 50090-0169 |
| 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 | Proficient Rx LP | 63187-122 |
| 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 | NuCare Pharmaceuticals, Inc. | 66267-158 |
| 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 | REMEDYREPACK INC. | 70518-4506 |
| 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 | Advanced Rx Pharmacy of Tennessee, LLC | 80425-0340 |
| Orphenadrine Citrate | Orphenadrine citrate 100 mg/1 | Tablet, Extended releaseOral | Northwind Health Company, LLC | 82868-040 |