Orphenadrine Citrate
- Product NDC
- 80425-0117
- 11-digit product format
- 804250117
- Labeler code
- 80425
- Product ID
- 80425-0117_2a996b2b-b5dc-65e7-e063-6394a90adeed
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Orphenadrine Citrate
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Advanced Rx Pharmacy of Tennessee, LLC
- Application
- ANDA040284
- Marketing category
- ANDA
- Marketing start
- 1998-06-19
- Substance
- ORPHENADRINE CITRATE
- Active strength
- 100 mg/1
- Pharmacologic classes
- Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Orphenadrine Citrate
- Brand name suffix
- ER
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ORPHENADRINE CITRATE | 100 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | X0A40N8I4S |
| Rxcui | 994521 |
DailyMed Package Descriptions#
Package NDC, Product, Description table| 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 table| 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 RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 80425-0117-1 | 80425011701 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (80425-0117-1) | 1998-06-19 | 0000-00-00 | No | No | Current |
| 80425-0117-2 | 80425011702 | 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (80425-0117-2) | 2023-08-17 | | No | No | Current |