Promethazine with Codeine
- Product NDC
- 0603-1585
- 11-digit product format
- 006031585
- Labeler code
- 0603
- Product ID
- 0603-1585_8fd47fe8-c377-4255-b64a-739a5f91ca74
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Promethazine Hydrochloride and Codeine Phosphate
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- Par Pharmaceutical
- Application
- ANDA040650
- Marketing category
- ANDA
- Marketing start
- 2006-01-31
- Marketing end
- 2021-05-31
- Substance
- PROMETHAZINE HYDROCHLORIDE; CODEINE PHOSPHATE
- Active strength
- 6 mg/5mL; mg/5mL
- Pharmacologic classes
- Phenothiazine [EPC],Phenothiazines [CS],Full Opioid Agonists [MoA],Opioid Agonist [EPC]
- DEA schedule
- CV
- NDC exclude flag
- No
- Listing certified through
- 0000-00-00
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0603-1585-54 | ML - Milliliter | 0603-1585 | 6e7dc7ee-b553-400a-a840-daea5bed5cda | 1 | 2012-07-24 |
| 0603-1585-58 | ML - Milliliter | 0603-1585 | afff1b92-1d8b-43bd-87b6-77ce50465614 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 991486 | codeine phosphate 10 MG / promethazine HCl 6.25 MG in 5 mL Oral Solution | PSN | e41b8b94-be20-4706-9454-e98c46731ab1 | 8 |
| 991486 | codeine phosphate 2 MG/ML / promethazine hydrochloride 1.25 MG/ML Oral Solution | SCD | e41b8b94-be20-4706-9454-e98c46731ab1 | 8 |
| 991486 | codeine phosphate 10 MG / promethazine HCl 6.25 MG per 5 ML Oral Syrup | SY | e41b8b94-be20-4706-9454-e98c46731ab1 | 8 |
| 991486 | codeine phosphate 10 MG / promethazine HCl 6.25 MG in 5 mL Oral Solution | PSN | 4e0d550e-6281-48ce-819f-ca37fcca53e0 | 2 |
| 991486 | codeine phosphate 10 MG / promethazine HCl 6.25 MG in 5 mL Oral Solution | PSN | 9408d9fa-ab74-4513-86bc-1f3d6d0dcf9a | 2 |
| 991486 | codeine phosphate 2 MG/ML / promethazine hydrochloride 1.25 MG/ML Oral Solution | SCD | 4e0d550e-6281-48ce-819f-ca37fcca53e0 | 2 |
| 991486 | codeine phosphate 2 MG/ML / promethazine hydrochloride 1.25 MG/ML Oral Solution | SCD | 9408d9fa-ab74-4513-86bc-1f3d6d0dcf9a | 2 |
| 991486 | codeine phosphate 10 MG / promethazine HCl 6.25 MG per 5 ML Oral Syrup | SY | 4e0d550e-6281-48ce-819f-ca37fcca53e0 | 2 |
| 991486 | codeine phosphate 10 MG / promethazine HCl 6.25 MG per 5 ML Oral Syrup | SY | 9408d9fa-ab74-4513-86bc-1f3d6d0dcf9a | 2 |
| 991486 | codeine phosphate 10 MG / promethazine HCl 6.25 MG in 5 mL Oral Solution | PSN | 0505fe62-ac59-475e-8c94-1933398be580 | 1 |
| 991486 | codeine phosphate 10 MG / promethazine HCl 6.25 MG in 5 mL Oral Solution | PSN | 3150fc52-6a33-42f6-b08a-266146661a5f | 1 |
| 991486 | codeine phosphate 2 MG/ML / promethazine hydrochloride 1.25 MG/ML Oral Solution | SCD | 0505fe62-ac59-475e-8c94-1933398be580 | 1 |
| 991486 | codeine phosphate 2 MG/ML / promethazine hydrochloride 1.25 MG/ML Oral Solution | SCD | 3150fc52-6a33-42f6-b08a-266146661a5f | 1 |
| 991486 | codeine phosphate 10 MG / promethazine HCl 6.25 MG per 5 ML Oral Syrup | SY | 0505fe62-ac59-475e-8c94-1933398be580 | 1 |
| 991486 | codeine phosphate 10 MG / promethazine HCl 6.25 MG per 5 ML Oral Syrup | SY | 3150fc52-6a33-42f6-b08a-266146661a5f | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0603-1585-54 | 00603158554 | 118 mL in 1 BOTTLE (0603-1585-54) | 118 ml | 2006-01-31 | 2021-05-31 | No | No | Current |
| 0603-1585-58 | 00603158558 | 473 mL in 1 BOTTLE (0603-1585-58) | 473 ml | 2006-01-31 | 2021-05-31 | No | No | Current |