Promethazine Hydrochloride and Codeine Phosphate
- Product NDC
- 0713-0823
- 11-digit product format
- 007130823
- Labeler code
- 0713
- Product ID
- 0713-0823_ad6f539c-d968-4a3b-9550-ab7e78bee74c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Promethazine Hydrochloride and Codeine Phosphate
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- Cosette Pharmaceuticals, Inc.
- Application
- ANDA200386
- Marketing category
- ANDA
- Marketing start
- 2025-12-19
- Substance
- CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE
- Active strength
- 10; 6.25 mg/5mL; mg/5mL
- Pharmacologic classes
- Full Opioid Agonists [MoA], Opioid Agonist [EPC], Phenothiazine [EPC], Phenothiazines [CS]
- DEA schedule
- CV
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Promethazine Hydrochloride and Codeine Phosphate
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| CODEINE PHOSPHATE | 10 mg/5mL |
| PROMETHAZINE HYDROCHLORIDE | 6.25 mg/5mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | GSL05Y1MN6, R61ZEH7I1I |
| Rxcui | 991486 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0713-0823-75 | Promethazine Hydrochloride and Codeine Phosphate | 473 mL in 1 BOTTLE, PLASTIC | SOLUTION | 473 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 0713-0823-75 | 00713082375 | 473 mL in 1 BOTTLE, PLASTIC (0713-0823-75) | 473 ml | 2025-12-19 | No | No | Historical |