Promethazine Hydrochloride
- Product NDC
- 0603-1584
- 11-digit product format
- 006031584
- Labeler code
- 0603
- Product ID
- 0603-1584_896908f5-e0f2-4ed0-8546-b24a0daef5aa
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Promethazine Hydrochloride
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- Par Pharmaceutical
- Application
- ANDA040643
- Marketing category
- ANDA
- Marketing start
- 2006-04-26
- Marketing end
- 2021-05-31
- Substance
- PROMETHAZINE HYDROCHLORIDE
- Active strength
- 6 mg/5mL
- Pharmacologic classes
- Phenothiazine [EPC],Phenothiazines [CS]
- NDC exclude flag
- No
- Listing certified through
- 0000-00-00
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 3036445d-7d13-4411-a100-f2ac5ab8a276 | Product name | 1 | 20240110 |
| 2e7222fb-e3f1-febd-962f-ddbb495d6b5f | Product name | 2 | 20220126 |
| 09d8330d-4fec-be98-3a66-f985140646b2 | Product name | 2 | 20210513 |
| 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 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 992432 | promethazine HCl 6.25 MG in 5 mL Oral Solution | PSN | 92aaf002-fe5d-418d-8f57-000bdad8d450 | 4 |
| 992432 | promethazine hydrochloride 1.25 MG/ML Oral Solution | SCD | 92aaf002-fe5d-418d-8f57-000bdad8d450 | 4 |
| 992432 | promethazine HCl 6.25 MG per 5 ML Oral Syrup | SY | 92aaf002-fe5d-418d-8f57-000bdad8d450 | 4 |
| 992432 | promethazine HCl 6.25 MG in 5 mL Oral Solution | PSN | e5be207b-122b-490f-a0d6-841132e45180 | 1 |
| 992432 | promethazine hydrochloride 1.25 MG/ML Oral Solution | SCD | e5be207b-122b-490f-a0d6-841132e45180 | 1 |
| 992432 | promethazine HCl 6.25 MG per 5 ML Oral Syrup | SY | e5be207b-122b-490f-a0d6-841132e45180 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0603-1584-54 | 00603158454 | 118 mL in 1 BOTTLE (0603-1584-54) | 118 ml | 2006-04-26 | 2021-04-30 | No | No | Current |
| 0603-1584-58 | 00603158458 | 473 mL in 1 BOTTLE (0603-1584-58) | 473 ml | 2006-04-26 | 2021-05-31 | No | No | Current |