Promethazine with Codeine
- Product NDC
- 67296-0516
- 11-digit product format
- 672960516
- Labeler code
- 67296
- Product ID
- 67296-0516_bba2e022-299f-5927-e053-2995a90a35f1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- promethazine hydrochloride and codeine phosphate
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- RedPharm Drug, Inc.
- Application
- ANDA088875
- Marketing category
- ANDA
- Marketing start
- 2021-01-01
- 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
- 2022-12-31
- 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 |
|---|
| 67296-0516-1 | Promethazine with Codeine | 120 mL in 1 BOTTLE | SOLUTION | 120 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 67296-0516 | PROMETHAZINE WITH CODEINE (PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE) SOLUTION [REDPHARM DRUG, INC.] | 3 | Legacy NDC, 1 package rows | 20210220_bba2e022-299e-5927-e053-2995a90a35f1.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 |
|---|
| 67296-0516-1 | 67296051601 | 120 mL in 1 BOTTLE (67296-0516-1) | 120 ml | 2021-01-01 | 0000-00-00 | No | No | Current |