Promethazine Hydrochloride
- Product NDC
- 68788-8162
- 11-digit product format
- 687888162
- Labeler code
- 68788
- Product ID
- 68788-8162_feee6de7-a830-4b36-832f-1983b282a970
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Promethazine Hydrochloride
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- Preferred Pharmaceuticals Inc.
- Application
- ANDA040643
- Marketing category
- ANDA
- Marketing start
- 2022-04-04
- Marketing end
- 0000-00-00
- Substance
- PROMETHAZINE HYDROCHLORIDE
- Active strength
- 6 mg/5mL
- Pharmacologic classes
- Phenothiazine [EPC], Phenothiazines [CS]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68788-8162 | PROMETHAZINE HYDROCHLORIDE SOLUTION [PREFERRED PHARMACEUTICALS INC.] | 3 | Legacy NDC | 20240805_feee6de7-a830-4b36-832f-1983b282a970.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 68788-8162-4 | 68788816204 | 473 mL in 1 BOTTLE (68788-8162-4) | 473 ml | 2022-04-04 | 0000-00-00 | No | No | Current |