NDC 80425-0117-01 - Orphenadrine Citrate ER
This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.
- Product NDC
- 80425-0117
- Requested NDC
- 80425-0117-01
- Package NDCs from labels
- 80425-0117-1, 80425-0117-2, 80425-0117-01
- Manufacturer
- Advanced Rx Pharmacy of Tennessee, LLC
- Effective date
- 2024-12-31
- Current FDA listing
- Not matched in FDA.report NDC product tables
DailyMed Labels#
| Label | Manufacturer | Effective date | Type |
|---|---|---|---|
| Orphenadrine Citrate ER - Advanced Rx Pharmacy of Tennessee, LLC | Advanced Rx Pharmacy of Tennessee, LLC | 2024-12-31 | HUMAN PRESCRIPTION DRUG LABEL |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 80425-0117-1 | Orphenadrine CitrateER | 30 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 30 | 6 | |
| 80425-0117-2 | Orphenadrine CitrateER | 60 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 60 | 6 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 80425-0117 | ORPHENADRINE CITRATE ER (ORPHENADRINE CITRATE) TABLET, EXTENDED RELEASE [ADVANCED RX PHARMACY OF TENNESSEE, LLC] | 6 | Current NDC, Legacy NDC, 2 package rows | 20250101_b5a6846a-ebb3-1fdd-e053-2a95a90a4130.zip |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 80425-0117-1 | EA - Each | 80425-0117 | 6875530b-65eb-4b30-8141-3c4a785f548a | 1 | 2023-06-06 |
| 80425-0117-2 | EA - Each | 80425-0117 | e8276d9e-8686-4581-a97e-dd1e868f4c5c | 1 | 2023-10-16 |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Orphenadrine Citrate | ORPHENADRINE CITRATE | Sandoz Inc | 239018ff-cec6-46de-ae9d-26c9ec034a32 | 2024-03-22 | Warnings, Adverse reactions | 994521 X0A40N8I4S |
| Orphenadrine Citrate | ORPHENADRINE CITRATE | Proficient Rx LP | cf620257-7497-44c1-9853-87f96d262fbd | 2023-12-01 | Warnings, Adverse reactions | ANDA040284 994521 X0A40N8I4S |
| Orphenadrine Citrate | ORPHENADRINE CITRATE | Sagent Pharmaceuticals | c8d8596a-b81f-4b83-a2f3-a55922ca4a82 | 2023-11-14 | Warnings, Adverse reactions | X0A40N8I4S |
| Orphenadrine Citrate | ORPHENADRINE CITRATE | Proficient Rx LP | 37e6a157-5d0d-4887-9a26-ed5521fb08e6 | 2019-11-01 | Warnings, Adverse reactions | 994521 X0A40N8I4S |
| Orphenadrine Citrate | ORPHENADRINE CITRATE | Actavis Pharma, Inc. | aec8ad3a-f717-4e74-b7b9-19debdaad79a | 2016-07-20 | Warnings, Adverse reactions | X0A40N8I4S |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.