Promethazine Hydrochloride
- Product NDC
- 43063-376
- 11-digit product format
- 430630376
- Labeler code
- 43063
- Product ID
- 43063-376_d2a80c8a-21c5-1bc4-e053-2995a90aa1d6
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Promethazine Hydrochloride
- Dosage form
- SUPPOSITORY
- Route
- RECTAL
- Labeler
- PD-Rx Pharmaceuticals, Inc.
- Application
- ANDA040428
- Marketing category
- ANDA
- Marketing start
- 2015-03-16
- Marketing end
- 0000-00-00
- Substance
- PROMETHAZINE HYDROCHLORIDE
- Active strength
- 13 mg/1
- Pharmacologic classes
- Phenothiazine [EPC],Phenothiazines [CS]
- NDC exclude flag
- No
- Listing certified through
- 2022-12-31
- Current FDA listing
- Historical FDA.report record
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 43063-376-01 | 43063037601 | 1 SUPPOSITORY in 1 BOTTLE, PLASTIC (43063-376-01) | 1 suppository | 2018-03-15 | 0000-00-00 | No | No | Current |
| 43063-376-02 | 43063037602 | 2 SUPPOSITORY in 1 BOTTLE, PLASTIC (43063-376-02) | 2 suppository | 2018-02-06 | 0000-00-00 | No | No | Current |