Promethazine VC with Codeine is a Oral Solution in the Human Prescription Drug category. It is labeled and distributed by Par Pharmaceutical. The primary component is Codeine Phosphate; Promethazine Hydrochloride; Phenylephrine Hydrochloride.
| Product ID | 0603-1588_02eac02b-67d5-463d-91e3-0ea7cb1b7ba4 |
| NDC | 0603-1588 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Promethazine VC with Codeine |
| Generic Name | Promethazine And Phenylephrine Hydrochloride And Codeine Phosphate |
| Dosage Form | Solution |
| Route of Administration | ORAL |
| Marketing Start Date | 2006-12-07 |
| Marketing Category | ANDA / ANDA |
| Application Number | ANDA040660 |
| Labeler Name | Par Pharmaceutical |
| Substance Name | CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE |
| Active Ingredient Strength | 10 mg/5mL; mg/5mL; mg/5mL |
| Pharm Classes | Full Opioid Agonists [MoA],Opioid Agonist [EPC],Phenothiazine [EPC],Phenothiazines [CS],alpha-1 Adrenergic Agonist [EPC],Adrenergic alpha1-Agonists [MoA] |
| DEA Schedule | CV |
| NDC Exclude Flag | N |
| Listing Certified Through | 2019-12-31 |
| Marketing Start Date | 2006-12-07 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | ANDA |
| Application Number | ANDA040660 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2006-12-07 |
| Marketing End Date | 2017-02-22 |
| Marketing Category | ANDA |
| Application Number | ANDA040660 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2006-12-07 |
| Marketing End Date | 2019-07-31 |
| Marketing Category | ANDA |
| Application Number | ANDA040660 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2006-12-07 |
| Marketing End Date | 2019-07-31 |
| Ingredient | Strength |
|---|---|
| CODEINE PHOSPHATE | 10 mg/5mL |
| SPL SET ID: | f6e9148b-52a9-46e9-ba50-7757215754d7 |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 0603-1588 | Promethazine VC with Codeine | Promethazine and Phenylephrine Hydrochloride and Codeine Phosphate |
| 55045-1266 | Promethazine VC With Codeine | Codeine Phosphate, Promethazine Hydrochloride, and Phenylephrine Hydrochloride |
| 0121-0925 | Promethazine VC with Codeine Oral Solution | Promethazine and Phenylephrine Hydrochloride and Codeine Phosphate |