ORPHENADRINE CITRATE
openFDA label record#
This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.
Verified complete openFDA source JSON
- Brand name
- ORPHENADRINE CITRATE
- Generic name
- ORPHENADRINE CITRATE
- Manufacturer
- Bryant Ranch Prepack
- Product type
- HUMAN PRESCRIPTION DRUG
- SPL set ID
- 1b4e379e-8051-421f-a0f4-ad9e6fb9476a
- SPL ID
- 4bc4698c-3d3c-e862-e063-6394a90a142f
- Version
- 103
- Effective date
- 2026-02-26
- Source export date
- 2026-09-28
- Source partition
- 10
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0010-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-09-28/4bbc9760f647649b787710953d978bd6419e899ba8b90f32c3d972aae43947f8/drug-label-0010-of-0014.json.zip
- Source manifest SHA-256
- cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
- Import run
- 20260929T050834Z
- Imported at
- 2026-09-29 06:06:13
| Harmonized routes |
|---|
| ORAL |
Harmonized identifier links#
Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.
| Type | Scope | Identifier | Source field |
|---|---|---|---|
| application applno | ANDA | 040284 | derived:openfda.application_number |
| application number | ANDA040284 | openfda.application_number | |
| brand name | ORPHENADRINE CITRATE | openfda.brand_name | |
| generic name | ORPHENADRINE CITRATE | openfda.generic_name | |
| manufacturer name | Bryant Ranch Prepack | openfda.manufacturer_name | |
| ndc | package | 72162-2020-1 | openfda.package_ndc |
| ndc | package | 72162-2020-5 | openfda.package_ndc |
| ndc | package | 72162-2020-6 | openfda.package_ndc |
| ndc | product | 72162-2020 | openfda.product_ndc |
| ndc11 | package | 72162202006 | derived:openfda.package_ndc |
| ndc11 | package | 72162202005 | derived:openfda.package_ndc |
| ndc11 | package | 72162202001 | derived:openfda.package_ndc |
| rxcui | 994521 | openfda.rxcui | |
| spl id | 4bc4698c-3d3c-e862-e063-6394a90a142f | id | |
| spl set id | 1b4e379e-8051-421f-a0f4-ad9e6fb9476a | set_id | |
| unii | X0A40N8I4S | openfda.unii |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
WARNINGS Some patients may experience transient episodes of light-headedness, dizziness or syncope. Orphenadrine may impair the ability of the patient to engage in potentially hazardous activities such as operating machinery or driving a motor vehicle; ambulatory patients should therefore be cautioned accordingly.
Adverse reactions cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
adverse reactions
ADVERSE REACTIONS Adverse reactions of orphenadrine are mainly due to the mild anticholinergic action of orphenadrine, and are usually associated with higher dosage. Dryness of the mouth is usually the first adverse effect to appear. When the daily dose is increased, possible adverse effects include: tachycardia, palpitation, urinary hesitancy or retention, blurred vision, dilatation of pupils, increased ocular tension, weakness, nausea, vomiting, headache, dizziness, constipation, drowsiness, hypersensitivity reactions, pruritus, hallucinations, agitation, tremor, gastric irritation, and rarely urticaria and other dermatoses. Infrequently, an elderly patient may experience some degree of mental confusion. These adverse reactions can usually be eliminated by reduction in dosage. Very rare cases of aplastic anemia associated with the use of orphenadrine tablets have been reported. No causal relationship has been established.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.