Promethazine Hydrochloride and Codeine Phosphate
- Product NDC
- 17856-0139
- 11-digit product format
- 178560139
- Labeler code
- 17856
- Product ID
- 17856-0139_2e141e93-7423-42f3-87cb-203dcc2192f6
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Promethazine Hydrochloride and Codeine Phosphate
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- ATLANTIC BIOLOGICALS CORP.
- Application
- ANDA214238
- Marketing category
- ANDA
- Marketing start
- 2020-10-08
- Marketing end
- 0000-00-00
- Substance
- PROMETHAZINE HYDROCHLORIDE; CODEINE PHOSPHATE
- Active strength
- 6 mg/5mL; mg/5mL
- Pharmacologic classes
- Phenothiazine [EPC],Phenothiazines [CS],Full Opioid Agonists [MoA],Opioid Agonist [EPC]
- DEA schedule
- CV
- NDC exclude flag
- No
- Listing certified through
- 2022-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 17856-0139-1 | Promethazine Hydrochloride and Codeine Phosphate | 72 in 1 BOX, UNIT-DOSE | SOLUTION | 72 | | 1 |
| 17856-0139-1 | Promethazine Hydrochloride and Codeine Phosphate | 5 mL in 1 CUP, UNIT-DOSE | SOLUTION | 5 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 17856-0139 | PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE SOLUTION [ATLANTIC BIOLOGICALS CORP.] | 1 | Legacy NDC, 2 package rows | 20210624_da31f63b-08d3-421c-8bc9-fd18029bf0a9.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 17856-0139-1 | 17856013901 | 72 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (17856-0139-1) > 5 mL in 1 CUP, UNIT-DOSE | 2021-06-23 | 0000-00-00 | No | No | Current |