Orphenadrine Citrate
- Product NDC
- 49999-046
- 11-digit product format
- 499990046
- Labeler code
- 49999
- Product ID
- 49999-046_018c5bb2-b5ea-4e62-8670-3e099c32ead9
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Orphenadrine Citrate
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Lake Erie Medical DBA Quality Care Products LLC
- Application
- ANDA040284
- Marketing category
- ANDA
- Marketing start
- 2011-02-07
- Marketing end
- 2026-11-30
- Substance
- ORPHENADRINE CITRATE
- Active strength
- 100 mg/1
- Pharmacologic classes
- Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]
- NDC exclude flag
- No
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Orphenadrine Citrate
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 |
|---|
| 49999-046-14 | Orphenadrine Citrate | 14 in 1 BOTTLE, PLASTIC | TABLET, EXTENDED RELEASE | 14 | | 3227 |
| 49999-046-30 | Orphenadrine Citrate | 30 in 1 BOTTLE, PLASTIC | TABLET, EXTENDED RELEASE | 30 | | 3227 |
| 49999-046-60 | Orphenadrine Citrate | 60 in 1 BOTTLE, PLASTIC | TABLET, EXTENDED RELEASE | 60 | | 3227 |
| 49999-046-90 | Orphenadrine Citrate | 90 in 1 BOTTLE, PLASTIC | TABLET, EXTENDED RELEASE | 90 | | 3227 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 49999-046 | ORPHENADRINE CITRATE (ORPHENADRINE CITRATE) TABLET, EXTENDED RELEASE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC] | 3227 | Current NDC, Legacy NDC, 4 package rows | 20241218_233915f1-7d58-4b4c-a2bb-e73179d61d07.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 |
|---|
| 49999-046-14 | 49999004614 | 14 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (49999-046-14) | 2011-02-07 | 0000-00-00 | No | No | Current |
| 49999-046-30 | 49999004630 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (49999-046-30) | 2011-02-07 | 0000-00-00 | No | No | Current |
| 49999-046-60 | 49999004660 | 60 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (49999-046-60) | 2011-02-07 | 2026-11-30 | No | No | Current |
| 49999-046-90 | 49999004690 | 90 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (49999-046-90) | 2018-06-12 | 0000-00-00 | No | No | Current |