PROMETHAZINE DM
- Product NDC
- 53002-4260
- 11-digit product format
- 530024260
- Labeler code
- 53002
- Product ID
- 53002-4260_ea53033c-ea3b-4e52-93cc-4cad4f7bf8e9
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Dextromethorphan Hydrobromide and Promethazine Hydrochloride
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- RPK Pharmaceuticals, Inc.
- Application
- ANDA040649
- Marketing category
- ANDA
- Marketing start
- 2006-02-14
- 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#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| bf324df6-7127-7deb-def5-2681c136cd03 | Product name | 3 | 20250325 |
| 3036445d-7d13-4411-a100-f2ac5ab8a276 | Product name | 1 | 20240110 |
| 43a1ed49-eae2-4840-8075-cb4b33478540 | Product name | 1 | 20230425 |
| 2e7222fb-e3f1-febd-962f-ddbb495d6b5f | Product name | 2 | 20220126 |
| 09d8330d-4fec-be98-3a66-f985140646b2 | Product name | 2 | 20210513 |
| ba088a92-ab5e-b2d4-e908-f5ea691b7587 | Product name | 7 | 20210201 |
| c5cd4727-ac49-4409-82b1-5bd8006c3ec7 | Product name | 1 | 20171122 |
| 4f881de7-085a-407e-abc2-faa3c0127432 | Product name | 1 | 20170811 |
| e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814 | Product name | 3 | 20150910 |
| 76633df9-0d59-4b88-03ed-21dee1b966f8 | Product name | 1 | 20140508 |
| d51697af-7f97-0559-95d1-fe94f3f031d5 | Product name | 1 | 20140508 |
| e949165d-714d-e548-2b76-0cb5def16f30 | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 53002-4260-1 | 2023-01-30 | C162847 | 48780-1 | 9d75b9d0-e8b7-f424-e053-dadaa90a57ce | Promethazine DM Oral Solution (Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral Solution) |
| 53002-4260-1 | 2020-12-17 | C162847 | 48780-1 | 9d75b9d0-e8b7-f424-e053-dadaa90a57ce | Promethazine DM Oral Solution (Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral Solution) |
| 53002-4260-1 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-e8b7-f424-e053-dadaa90a57ce | Promethazine DM Oral Solution (Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral Solution) |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 53002-4260-1 | PROMETHAZINE DM | 118 mL in 1 BOTTLE | SOLUTION | 118 | 3 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 53002-4260 | PROMETHAZINE DM (DEXTROMETHORPHAN HYDROBROMIDE AND PROMETHAZINE HYDROCHLORIDE) SOLUTION [RPK PHARMACEUTICALS, INC.] | 3 | Legacy NDC, 1 package rows | 20201218_5d035ba4-7d6d-4842-b34f-691c26749b33.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 991528 | promethazine HCl 6.25 MG / dextromethorphan HBr 15 MG in 5 mL Oral Solution | PSN | 5d035ba4-7d6d-4842-b34f-691c26749b33 | 3 |
| 991528 | dextromethorphan hydrobromide 3 MG/ML / promethazine hydrochloride 1.25 MG/ML Oral Solution | SCD | 5d035ba4-7d6d-4842-b34f-691c26749b33 | 3 |
| 991528 | dextromethorphan HBr 15 MG / promethazine HCl 6.25 MG per 5 ML Oral Solution | SY | 5d035ba4-7d6d-4842-b34f-691c26749b33 | 3 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 53002-4260-1 | 53002426001 | 118 mL in 1 BOTTLE (53002-4260-1) | 118 ml | 2018-10-01 | 0000-00-00 | No | No | Current |