Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral
- Product NDC
- 53002-4262
- 11-digit product format
- 530024262
- Labeler code
- 53002
- Product ID
- 53002-4262_4b99239e-0abb-4e42-b144-abd0a36192b0
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- RPK Pharmaceuticals, Inc.
- Application
- ANDA040649
- Marketing category
- ANDA
- Marketing start
- 2020-10-05
- Marketing end
- 0000-00-00
- Substance
- DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE
- Active strength
- 15 mg/5mL; mg/5mL
- Pharmacologic classes
- Phenothiazine [EPC], Phenothiazines [CS], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- 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 |
|---|
| 53002-4262-1 | Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral | 118 mL in 1 BOTTLE | SOLUTION | 118 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 53002-4262 | PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE ORAL SOLUTION [RPK PHARMACEUTICALS, INC.] | 1 | Legacy NDC, 1 package rows | 20220331_cb36756d-4a5e-4857-9767-99a7473a3842.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 |
|---|
| 53002-4262-1 | 53002426201 | 118 mL in 1 BOTTLE (53002-4262-1) | 118 ml | 2022-10-01 | 0000-00-00 | No | No | Current |