Promethazine with Codeine
- Product NDC
- 21695-336
- 11-digit product format
- 216950336
- Labeler code
- 21695
- Product ID
- 21695-336_1b182a47-6803-4b84-882e-544306ab0329
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Promethazine Hydrochloride and Codeine Phosphate
- Dosage form
- SYRUP
- Route
- ORAL
- Labeler
- Rebel Distributors Corp
- Application
- ANDA040650
- Marketing category
- ANDA
- Marketing start
- 2006-01-31
- Marketing end
- 0000-00-00
- Substance
- CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE
- Active strength
- 10 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
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 |
|---|
| 21695-336-04 | Promethazine with Codeine | 118 mL in 1 BOTTLE | SYRUP | 118 | | 2 |
| 21695-336-16 | Promethazine with Codeine | 473 mL in 1 BOTTLE | SYRUP | 473 | | 2 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 21695-336 | PROMETHAZINE WITH CODEINE (PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE) SYRUP [REBEL DISTRIBUTORS CORP] | 2 | Legacy NDC, 2 package rows | 20111118_9408d9fa-ab74-4513-86bc-1f3d6d0dcf9a.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Status |
|---|
| 21695-336-04 | 21695033604 | 118 mL in 1 BOTTLE | 118 ml | Historical |
| 21695-336-16 | 21695033616 | 473 mL in 1 BOTTLE | 473 ml | Historical |