Orphenadrine citrate
- Product NDC
- 0641-6182
- 11-digit product format
- 006416182
- Labeler code
- 0641
- Product ID
- 0641-6182_dde13b7f-78fb-4b9a-bc16-a41bf45042be
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Orphenadrine citrate
- Dosage form
- INJECTION
- Route
- INTRAMUSCULAR; INTRAVENOUS
- Labeler
- Hikma Pharmaceuticals USA Inc.
- Application
- ANDA040463
- Marketing category
- ANDA
- Marketing start
- 2003-04-28
- Substance
- ORPHENADRINE CITRATE
- Active strength
- 60 mg/2mL
- 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 | 60 mg/2mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | X0A40N8I4S |
| Rxcui | 994541 |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0641-6182-01 | Orphenadrine citrate | 2 mL in 1 VIAL | INJECTION | 2 | | 5 |
| 0641-6182-10 | Orphenadrine citrate | 10 in 1 BOX | INJECTION | 10 | | 5 |
| 0641-6182-25 | Orphenadrine citrate | 25 in 1 BOX | INJECTION | 25 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0641-6182 | ORPHENADRINE CITRATE INJECTION [HIKMA PHARMACEUTICALS USA INC.] | 5 | Current NDC, Legacy NDC, 3 package rows | 20240809_ed406e8a-ec00-4711-ae2b-3c5af4f15438.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0641-6182-01 | 00641618201 | 2 mL in 1 VIAL | 2 ml | | | | | Historical |
| 0641-6182-10 | 00641618210 | 10 VIAL in 1 BOX (0641-6182-10) > 2 mL in 1 VIAL (0641-6182-01) | 10 vial | 2003-04-28 | 0000-00-00 | No | No | Current |
| 0641-6182-25 | 00641618225 | 25 BOX in 1 BOX (0641-6182-25) / 10 VIAL in 1 BOX (0641-6182-10) / 2 mL in 1 VIAL (0641-6182-01) | 25 box | 2003-04-28 | | No | No | Current |