Orphenadrine Citrate
- Product NDC
- 66267-158
- 11-digit product format
- 662670158
- Labeler code
- 66267
- Product ID
- 66267-158_1f93e675-f088-ddc1-e063-6294a90a42ba
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Orphenadrine Citrate
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- NuCare Pharmaceuticals, Inc.
- 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
- 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 |
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 66267-158-20 | Orphenadrine Citrate | 20 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 20 | | 5 |
| 66267-158-30 | Orphenadrine Citrate | 30 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 30 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 66267-158 | ORPHENADRINE CITRATE TABLET, EXTENDED RELEASE [NUCARE PHARMACEUTICALS, INC.] | 5 | Current NDC, Legacy NDC, 2 package rows | 20240815_3eb1b1cc-ed7a-6f0f-e054-00144ff88e88.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 |
|---|
| 66267-158-20 | 66267015820 | 20 TABLET, EXTENDED RELEASE in 1 BOTTLE (66267-158-20) | 2016-10-12 | 0000-00-00 | No | No | Current |
| 66267-158-30 | 66267015830 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (66267-158-30) | 2016-10-12 | 0000-00-00 | No | No | Current |