Promethazine VC with Codeine Oral Solution
- Product NDC
- 0121-0925
- 11-digit product format
- 001210925
- Labeler code
- 0121
- Product ID
- 0121-0925_bdd6aba3-0504-a99b-e053-2995a90a6467
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Promethazine and Phenylephrine Hydrochloride and Codeine Phosphate
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- Pharmaceutical Associates, Inc.
- Application
- ANDA040660
- Marketing category
- ANDA
- Marketing start
- 2021-03-18
- Marketing end
- 0000-00-00
- Substance
- CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE
- Active strength
- 10 mg/5mL; mg/5mL; mg/5mL
- Pharmacologic classes
- Full Opioid Agonists [MoA],Opioid Agonist [EPC],Phenothiazine [EPC],Phenothiazines [CS],alpha-1 Adrenergic Agonist [EPC],Adrenergic alpha1-Agonists [MoA]
- DEA schedule
- CV
- NDC exclude flag
- No
- Listing certified through
- 2022-12-31
- 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 |
|---|
| 0121-0925 | PROMETHAZINE VC WITH CODEINE ORAL SOLUTION (PROMETHAZINE AND PHENYLEPHRINE HYDROCHLORIDE AND CODEINE PHOSPHATE) SOLUTION [PAI HOLDINGS, LLC] | 4 | Legacy NDC | 20240131_75c68c3a-8d8d-4a13-87de-3eb73608c943.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0121-0925-16 | 00121092516 | 473 mL in 1 BOTTLE (0121-0925-16) | 473 ml | 2021-03-18 | 0000-00-00 | No | No | Current |