Promethazine Hydrochloride and Codeine Phosphate
- Product NDC
- 27808-065
- 11-digit product format
- 278080065
- Labeler code
- 27808
- Product ID
- 27808-065_981526cb-82c9-4a44-a891-7c44c708163e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Promethazine Hydrochloride and Codeine Phosphate
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- Cranbury Pharmaceuticals, LLC
- Application
- ANDA200386
- Marketing category
- ANDA
- Marketing start
- 2018-03-12
- Marketing end
- 2027-03-01
- 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
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Promethazine Hydrochloride and Codeine Phosphate
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 |
|---|
| 27808-065-01 | Promethazine Hydrochloride and Codeine Phosphate | 237 mL in 1 BOTTLE, PLASTIC | SOLUTION | 237 | | 13 |
| 27808-065-02 | Promethazine Hydrochloride and Codeine Phosphate | 473 mL in 1 BOTTLE, PLASTIC | SOLUTION | 473 | | 13 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 27808-065 | PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE SOLUTION [TRIS PHARMA INC] | 10 | Current NDC, Legacy NDC, 2 package rows | 20231220_785c605e-1907-4fac-8b69-d504a2076f8e.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 |
|---|
| 27808-065-01 | 27808006501 | 237 mL in 1 BOTTLE, PLASTIC | 237 ml | | | | | Historical |
| 27808-065-02 | 27808006502 | 473 mL in 1 BOTTLE, PLASTIC (27808-065-02) | 473 ml | 2018-03-12 | 2027-03-01 | No | No | Current |