Promethazine with Codeine
- Product NDC
- 33261-391
- 11-digit product format
- 332610391
- Labeler code
- 33261
- Product ID
- 33261-391_bbb202cc-8929-4ad4-bb03-3737038a6e4e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Promethazine Hydrochloride and Codeine Phosphate
- Dosage form
- SYRUP
- Route
- ORAL
- Labeler
- Aidarex Pharmaceuticals LLC
- Application
- ANDA040650
- Marketing category
- ANDA
- Marketing start
- 2006-01-31
- Marketing end
- 0000-00-00
- 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
- 2019-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 33261-391-01 | Promethazine with Codeine | 118 mL in 1 BOTTLE, PLASTIC | SYRUP | 118 | | 1 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 33261-391 | PROMETHAZINE WITH CODEINE (PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE) SYRUP [AIDAREX PHARMACEUTICALS LLC] | 1 | Legacy NDC, 1 package rows | 20140213_3150fc52-6a33-42f6-b08a-266146661a5f.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Status |
|---|
| 33261-391-01 | 33261039101 | 118 mL in 1 BOTTLE, PLASTIC | 118 ml | Historical |