Promethazine Hydrochloride and Dextromethorphan Hydrobromide
- Product NDC
- 50090-4934
- 11-digit product format
- 500904934
- Labeler code
- 50090
- Product ID
- 50090-4934_7ac0700a-9ad1-4b20-979a-36a8c2719e4f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- promethazine hydrochloride and dextromethorphan hydrobromide
- Dosage form
- SYRUP
- Route
- ORAL
- Labeler
- A-S Medication Solutions
- Application
- ANDA088864
- Marketing category
- ANDA
- Marketing start
- 1985-01-04
- Marketing end
- 0000-00-00
- Substance
- DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE
- Active strength
- 15 mg/5mL; mg/5mL
- Pharmacologic classes
- Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC],Sigma-1 Agonist [EPC],Uncompetitive NMDA Receptor Antagonists [MoA],Sigma-1 Receptor Agonists [MoA],Phenothiazine [EPC],Phenothiazines [CS]
- NDC exclude flag
- No
- Listing certified through
- 2021-12-31
- 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 |
|---|
| 50090-4934-0 | Promethazine Hydrochloride and Dextromethorphan Hydrobromide | 473 mL in 1 BOTTLE, PLASTIC | SYRUP | 473 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50090-4934 | PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE SYRUP [A-S MEDICATION SOLUTIONS] | 1 | Legacy NDC, 1 package rows | 20200319_4de7fb46-3610-44c4-a9bf-e7fe287da70b.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 |
|---|
| 50090-4934-0 | 50090493400 | 473 mL in 1 BOTTLE, PLASTIC (50090-4934-0) | 473 ml | 2020-02-27 | 0000-00-00 | No | No | Current |