ORPHENADRINE CITRATE
- Product NDC
- 70518-4506
- 11-digit product format
- 705184506
- Labeler code
- 70518
- Product ID
- 70518-4506_508a41a9-403b-e409-e063-6294a90ad6fa
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ORPHENADRINE CITRATE
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA040284
- Marketing category
- ANDA
- Marketing start
- 2025-10-15
- 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 |
|---|
| 70518-4506-0 | ORPHENADRINE CITRATE | 14 in 1 BOTTLE, PLASTIC | TABLET, EXTENDED RELEASE | 14 | | 3 |
| 70518-4506-1 | ORPHENADRINE CITRATE | 14 in 1 BOTTLE, PLASTIC | TABLET, EXTENDED RELEASE | 14 | | 3 |
| 70518-4506-2 | ORPHENADRINE CITRATE | 50 in 1 BOX | TABLET, EXTENDED RELEASE | 50 | | 3 |
| 70518-4506-3 | ORPHENADRINE CITRATE | 1 in 1 POUCH | TABLET, EXTENDED RELEASE | 1 | | 3 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 70518-4506-0 | 70518450600 | 14 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (70518-4506-0) | | 2025-10-15 | No | No | Historical |
| 70518-4506-1 | 70518450601 | 14 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (70518-4506-1) | | 2025-12-20 | No | No | Historical |
| 70518-4506-2 | 70518450602 | 50 POUCH in 1 BOX (70518-4506-2) / 1 TABLET, EXTENDED RELEASE in 1 POUCH (70518-4506-3) | 50 pouch | 2026-04-28 | No | No | Historical |
| 70518-4506-3 | 70518450603 | 1 in 1 POUCH | | | | | Historical |