ORPHENADRINE CITRATE
- Product NDC
- 82868-040
- 11-digit product format
- 828680040
- Labeler code
- 82868
- Product ID
- 82868-040_47f8f308-ca39-d280-e063-6394a90a49e9
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ORPHENADRINE CITRATE
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Northwind Health Company, LLC
- Application
- ANDA040284
- Marketing category
- ANDA
- Marketing start
- 2024-01-30
- 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
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- ORPHENADRINE CITRATE
- Listing expiration
- 2027-12-31
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 |
|---|
| 82868-040-14 | ORPHENADRINE CITRATE | 14 in 1 BOTTLE, PLASTIC | TABLET, EXTENDED RELEASE | 14 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 82868-040 | ORPHENADRINE CITRATE TABLET, EXTENDED RELEASE [NORTHWIND PHARMACEUTICALS, LLC] | 1 | Current NDC, 1 package rows | 20240220_106be130-b4f8-5ca1-e063-6294a90a1590.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 82868-040-14 | 82868004014 | 14 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (82868-040-14) | 2024-01-30 | No | No | Current |