promethazine hydrochloride and codeine phosphate
- Product NDC
- 12634-907
- 11-digit product format
- 126340907
- Labeler code
- 12634
- Product ID
- 12634-907_477cedee-6bcf-2a34-e054-00144ff8d46c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- promethazine hydrochloride and codeine phosphate
- Dosage form
- SYRUP
- Route
- ORAL
- Labeler
- Apotheca Inc.
- Application
- ANDA090180
- Marketing category
- ANDA
- Marketing start
- 2010-03-17
- 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
- 2020-12-31
- 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 |
|---|
| 12634-907-02 | promethazine hydrochloride and codeine phosphate | 60 mL in 1 BOTTLE | SYRUP | 60 | | 5 |
| 12634-907-04 | promethazine hydrochloride and codeine phosphate | 120 mL in 1 BOTTLE | SYRUP | 120 | | 5 |
| 12634-907-06 | promethazine hydrochloride and codeine phosphate | 178 mL in 1 BOTTLE | SYRUP | 178 | | 5 |
| 12634-907-08 | promethazine hydrochloride and codeine phosphate | 237 mL in 1 BOTTLE | SYRUP | 237 | | 5 |
| 12634-907-16 | promethazine hydrochloride and codeine phosphate | 473 mL in 1 BOTTLE | SYRUP | 473 | | 5 |
| 12634-907-28 | promethazine hydrochloride and codeine phosphate | 3785 mL in 1 BLISTER PACK | SYRUP | 3785 | | 5 |
| 12634-907-32 | promethazine hydrochloride and codeine phosphate | 946 mL in 1 BOTTLE | SYRUP | 946 | | 5 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| CODEINE PHOSPHATE | ACTIVE INGREDIENT | GSL05Y1MN6 | PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE SYRUP [APOTHECA, INC] | 2 | |
| PROMETHAZINE HYDROCHLORIDE | ACTIVE INGREDIENT | R61ZEH7I1I | PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE SYRUP [APOTHECA, INC] | 2 | |
| CODEINE ANHYDROUS | ACTIVE MOIETY | UX6OWY2V7J | PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE SYRUP [APOTHECA, INC] | 2 | |
| PROMETHAZINE | ACTIVE MOIETY | FF28EJQ494 | PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE SYRUP [APOTHECA, INC] | 2 | |
| ALCOHOL | INACTIVE INGREDIENT | 3K9958V90M | PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE SYRUP [APOTHECA, INC] | 2 | |
| ASCORBIC ACID | INACTIVE INGREDIENT | PQ6CK8PD0R | PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE SYRUP [APOTHECA, INC] | 2 | |
| CITRIC ACID MONOHYDRATE | INACTIVE INGREDIENT | 2968PHW8QP | PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE SYRUP [APOTHECA, INC] | 2 | |
| D&C YELLOW NO. 10 | INACTIVE INGREDIENT | 35SW5USQ3G | PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE SYRUP [APOTHECA, INC] | 2 | |
| EDETATE DISODIUM | INACTIVE INGREDIENT | 7FLD91C86K | PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE SYRUP [APOTHECA, INC] | 2 | |
| FD&C BLUE NO. 1 | INACTIVE INGREDIENT | H3R47K3TBD | PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE SYRUP [APOTHECA, INC] | 2 | |
| FD&C RED NO. 40 | INACTIVE INGREDIENT | WZB9127XOA | PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE SYRUP [APOTHECA, INC] | 2 | |
| GLYCERIN | INACTIVE INGREDIENT | PDC6A3C0OX | PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE SYRUP [APOTHECA, INC] | 2 | |
| METHYLPARABEN | INACTIVE INGREDIENT | A2I8C7HI9T | PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE SYRUP [APOTHECA, INC] | 2 | |
| SODIUM CITRATE | INACTIVE INGREDIENT | 1Q73Q2JULR | PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE SYRUP [APOTHECA, INC] | 2 | |
| SUCRALOSE | INACTIVE INGREDIENT | 96K6UQ3ZD4 | PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE SYRUP [APOTHECA, INC] | 2 | |
| SUCROSE | INACTIVE INGREDIENT | C151H8M554 | PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE SYRUP [APOTHECA, INC] | 2 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE SYRUP [APOTHECA, INC] | 2 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 12634-907 | PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE SYRUP [APOTHECA INC.] | 5 | Legacy NDC, 7 package rows | 20170201_68639fd1-3fd5-4459-8018-51f136e3ed37.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 12634-907-02 | 12634090702 | 60 mL in 1 BOTTLE (12634-907-02) | 60 ml | 2010-03-17 | 0000-00-00 | No | No | Current |
| 12634-907-04 | 12634090704 | 120 mL in 1 BOTTLE (12634-907-04) | 120 ml | 2010-03-17 | 0000-00-00 | No | No | Current |
| 12634-907-06 | 12634090706 | 178 mL in 1 BOTTLE (12634-907-06) | 178 ml | 2010-03-17 | 0000-00-00 | No | No | Current |
| 12634-907-08 | 12634090708 | 237 mL in 1 BOTTLE (12634-907-08) | 237 ml | 2010-03-17 | 0000-00-00 | No | No | Current |
| 12634-907-16 | 12634090716 | 473 mL in 1 BOTTLE (12634-907-16) | 473 ml | 2010-03-17 | 0000-00-00 | No | No | Current |
| 12634-907-28 | 12634090728 | 3785 mL in 1 BLISTER PACK (12634-907-28) | 3785 ml | 2010-03-17 | 0000-00-00 | No | No | Current |
| 12634-907-32 | 12634090732 | 946 mL in 1 BOTTLE (12634-907-32) | 946 ml | 2010-03-17 | 0000-00-00 | No | No | Current |