Orphenadrine Citrate
- Product NDC
- 0115-2011
- 11-digit product format
- 001152011
- Labeler code
- 0115
- Product ID
- 0115-2011_b32f83c1-81bd-46e2-8808-ea055c4418f9
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ORPHENADRINE CITRATE
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Amneal Pharmaceuticals of New York LLC
- Application
- ANDA040368
- Marketing category
- ANDA
- Marketing start
- 2000-06-23
- Marketing end
- 0000-00-00
- 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
- 2021-12-31
- Current FDA listing
- Historical FDA.report record
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0115-2011-01 | Orphenadrine Citrate | 100 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 100 | | 6 |
| 0115-2011-02 | Orphenadrine Citrate | 500 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 500 | | 6 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| ORPHENADRINE CITRATE | ACTIVE INGREDIENT | X0A40N8I4S | ORPHENADRINE CITRATE TABLET, EXTENDED RELEASE [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.] | 2 | |
| ORPHENADRINE CITRATE | ACTIVE INGREDIENT | X0A40N8I4S | ORPHENADRINE CITRATE (ORPHENADRINE CITRATE) TABLET, EXTENDED RELEASE [H.J. HARKINS COMPANY, INC.] | 2 | |
| ORPHENADRINE | ACTIVE MOIETY | AL805O9OG9 | ORPHENADRINE CITRATE TABLET, EXTENDED RELEASE [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.] | 2 | |
| ORPHENADRINE | ACTIVE MOIETY | AL805O9OG9 | ORPHENADRINE CITRATE (ORPHENADRINE CITRATE) TABLET, EXTENDED RELEASE [H.J. HARKINS COMPANY, INC.] | 2 | |
| ETHYLCELLULOSES | INACTIVE INGREDIENT | 7Z8S9VYZ4B | ORPHENADRINE CITRATE TABLET, EXTENDED RELEASE [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.] | 2 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | ORPHENADRINE CITRATE TABLET, EXTENDED RELEASE [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.] | 2 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | ORPHENADRINE CITRATE (ORPHENADRINE CITRATE) TABLET, EXTENDED RELEASE [H.J. HARKINS COMPANY, INC.] | 2 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | ORPHENADRINE CITRATE TABLET, EXTENDED RELEASE [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.] | 2 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | ORPHENADRINE CITRATE (ORPHENADRINE CITRATE) TABLET, EXTENDED RELEASE [H.J. HARKINS COMPANY, INC.] | 2 | |
| POVIDONE | INACTIVE INGREDIENT | FZ989GH94E | ORPHENADRINE CITRATE (ORPHENADRINE CITRATE) TABLET, EXTENDED RELEASE [H.J. HARKINS COMPANY, INC.] | 2 | |
| POVIDONES | INACTIVE INGREDIENT | FZ989GH94E | ORPHENADRINE CITRATE TABLET, EXTENDED RELEASE [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.] | 2 | |
| ORPHENADRINE CITRATE | ACTIVE INGREDIENT | X0A40N8I4S | ORPHENADRINE CITRATE TABLET, EXTENDED RELEASE [STAT RX USA LLC] | 1 | |
| ORPHENADRINE CITRATE | ACTIVE INGREDIENT | X0A40N8I4S | ORPHENADRINE CITRATE TABLET, EXTENDED RELEASE [STAT RX USA LLC] | 1 | |
| ORPHENADRINE | ACTIVE MOIETY | AL805O9OG9 | ORPHENADRINE CITRATE TABLET, EXTENDED RELEASE [STAT RX USA LLC] | 1 | |
| ORPHENADRINE | ACTIVE MOIETY | AL805O9OG9 | ORPHENADRINE CITRATE TABLET, EXTENDED RELEASE [STAT RX USA LLC] | 1 | |
| ETHYLCELLULOSES | INACTIVE INGREDIENT | 7Z8S9VYZ4B | ORPHENADRINE CITRATE TABLET, EXTENDED RELEASE [STAT RX USA LLC] | 1 | |
| ETHYLCELLULOSES | INACTIVE INGREDIENT | 7Z8S9VYZ4B | ORPHENADRINE CITRATE TABLET, EXTENDED RELEASE [STAT RX USA LLC] | 1 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | ORPHENADRINE CITRATE TABLET, EXTENDED RELEASE [STAT RX USA LLC] | 1 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | ORPHENADRINE CITRATE TABLET, EXTENDED RELEASE [STAT RX USA LLC] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | ORPHENADRINE CITRATE TABLET, EXTENDED RELEASE [STAT RX USA LLC] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | ORPHENADRINE CITRATE TABLET, EXTENDED RELEASE [STAT RX USA LLC] | 1 | |
| POVIDONE | INACTIVE INGREDIENT | FZ989GH94E | ORPHENADRINE CITRATE TABLET, EXTENDED RELEASE [STAT RX USA LLC] | 1 | |
| POVIDONE | INACTIVE INGREDIENT | FZ989GH94E | ORPHENADRINE CITRATE TABLET, EXTENDED RELEASE [STAT RX USA LLC] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0115-2011 | ORPHENADRINE CITRATE TABLET, EXTENDED RELEASE [AMNEAL PHARMACEUTICALS OF NEW YORK LLC] | 6 | Legacy NDC, 2 package rows | 20201230_6e89e43d-a3fc-481e-8aed-d6955fa2a14b.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 |
|---|
| 0115-2011-01 | 00115201101 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (0115-2011-01) | 2000-06-23 | 0000-00-00 | No | No | Current |
| 0115-2011-02 | 00115201102 | 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (0115-2011-02) | 2000-06-23 | 0000-00-00 | No | No | Current |