Prometh with Codeine
- Product NDC
- 42254-140
- 11-digit product format
- 422540140
- Labeler code
- 42254
- Product ID
- 42254-140_a4fd8978-2036-43cb-ab16-b0dd98d6cd5b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Promethazine Hydrochloride and Codeine Phosphate
- Dosage form
- SYRUP
- Route
- ORAL
- Labeler
- Rebel Distributors Corp
- Application
- ANDA088763
- Marketing category
- ANDA
- Marketing start
- 1984-10-31
- Marketing end
- 0000-00-00
- Substance
- PROMETHAZINE HYDROCHLORIDE; CODEINE PHOSPHATE
- Active strength
- 6 mg/5mL; mg/5mL
- Pharmacologic classes
- Phenothiazine [EPC],Phenothiazines [CS]
- DEA schedule
- CV
- NDC exclude flag
- E
- Listing certified through
- 2017-12-31
- Current FDA listing
- Historical FDA.report record
NDC auxiliary status#
Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status.
Dataset, Scope, Product NDC table| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|
| excluded product | product | 42254-140 | | I | Inactivated by FDA | | 2026-07-31 |
| excluded package | package | 42254-140 | 42254-140-04 | I | Inactivated by FDA | | 2026-07-31 |
Orange Book products#
Application-product, Trade name, Ingredient table| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|
| A088763-001 | PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE | CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE | 10MG/5ML;6.25MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SYRUP / ORAL | | RLD | 1984-10-31 |
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 |
|---|
| 42254-140-04 | Prometh with Codeine | 118 mL in 1 BOTTLE | SYRUP | 118 | | 1 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 42254-140 | PROMETH WITH CODEINE (PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE) SYRUP [REBEL DISTRIBUTORS CORP] | 1 | Legacy NDC, 1 package rows | 20120411_a4fd8978-2036-43cb-ab16-b0dd98d6cd5b.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Status |
|---|
| 42254-140-04 | 42254014004 | 118 mL in 1 BOTTLE | 118 ml | Historical |