Promethazine Hydrochloride and Codeine Phosphate
- Product NDC
- 12634-909
- 11-digit product format
- 126340909
- Labeler code
- 12634
- Product ID
- 12634-909_49d71d3b-fb89-5738-e054-00144ff8d46c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Promethazine Hydrochloride and Codeine Phosphate
- Dosage form
- SYRUP
- Route
- ORAL
- Labeler
- Apotheca Inc
- Application
- ANDA040151
- Marketing category
- ANDA
- Marketing start
- 1997-08-26
- Marketing end
- 0000-00-00
- Substance
- CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE
- Active strength
- 10 mg/5mL; mg/5mL
- Pharmacologic classes
- Full Opioid Agonists [MoA],Opioid Agonist [EPC],Phenothiazine [EPC],Phenothiazines [CS]
- DEA schedule
- CV
- NDC exclude flag
- No
- Listing certified through
- 2019-12-31
- 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 |
|---|
| 12634-909-02 | Promethazine Hydrochloride and Codeine Phosphate | 60 mL in 1 BOTTLE | SYRUP | 60 | | 5 |
| 12634-909-04 | Promethazine Hydrochloride and Codeine Phosphate | 120 mL in 1 BOTTLE | SYRUP | 120 | | 5 |
| 12634-909-06 | Promethazine Hydrochloride and Codeine Phosphate | 178 mL in 1 BOTTLE | SYRUP | 178 | | 5 |
| 12634-909-08 | Promethazine Hydrochloride and Codeine Phosphate | 237 mL in 1 BOTTLE | SYRUP | 237 | | 5 |
| 12634-909-16 | Promethazine Hydrochloride and Codeine Phosphate | 473 mL in 1 BOTTLE | SYRUP | 473 | | 5 |
| 12634-909-28 | Promethazine Hydrochloride and Codeine Phosphate | 3785 mL in 1 BOTTLE | SYRUP | 3785 | | 5 |
| 12634-909-32 | 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 WITH CODEINE LIQUID [APOTHECA, INC.] | 1 | |
| PROMETHAZINE HYDROCHLORIDE | ACTIVE INGREDIENT | R61ZEH7I1I | PROMETHAZINE WITH CODEINE LIQUID [APOTHECA, INC.] | 1 | |
| CODEINE | ACTIVE MOIETY | Q830PW7520 | PROMETHAZINE WITH CODEINE LIQUID [APOTHECA, INC.] | 1 | |
| PROMETHAZINE | ACTIVE MOIETY | FF28EJQ494 | PROMETHAZINE WITH CODEINE LIQUID [APOTHECA, INC.] | 1 | |
| ALCOHOL | INACTIVE INGREDIENT | 3K9958V90M | PROMETHAZINE WITH CODEINE LIQUID [APOTHECA, INC.] | 1 | |
| ASCORBIC ACID | INACTIVE INGREDIENT | PQ6CK8PD0R | PROMETHAZINE WITH CODEINE LIQUID [APOTHECA, INC.] | 1 | |
| CITRIC ACID | INACTIVE INGREDIENT | 2968PHW8QP | PROMETHAZINE WITH CODEINE LIQUID [APOTHECA, INC.] | 1 | |
| D&C RED NO. 33 | INACTIVE INGREDIENT | 9DBA0SBB0L | PROMETHAZINE WITH CODEINE LIQUID [APOTHECA, INC.] | 1 | |
| EDETATE DISODIUM | INACTIVE INGREDIENT | 7FLD91C86K | PROMETHAZINE WITH CODEINE LIQUID [APOTHECA, INC.] | 1 | |
| FD&C BLUE NO. 1 | INACTIVE INGREDIENT | H3R47K3TBD | PROMETHAZINE WITH CODEINE LIQUID [APOTHECA, INC.] | 1 | |
| FD&C YELLOW NO. 6 | INACTIVE INGREDIENT | H77VEI93A8 | PROMETHAZINE WITH CODEINE LIQUID [APOTHECA, INC.] | 1 | |
| GLYCERIN | INACTIVE INGREDIENT | PDC6A3C0OX | PROMETHAZINE WITH CODEINE LIQUID [APOTHECA, INC.] | 1 | |
| METHYLPARABEN | INACTIVE INGREDIENT | A2I8C7HI9T | PROMETHAZINE WITH CODEINE LIQUID [APOTHECA, INC.] | 1 | |
| SACCHARIN SODIUM | INACTIVE INGREDIENT | SB8ZUX40TY | PROMETHAZINE WITH CODEINE LIQUID [APOTHECA, INC.] | 1 | |
| SODIUM BENZOATE | INACTIVE INGREDIENT | OJ245FE5EU | PROMETHAZINE WITH CODEINE LIQUID [APOTHECA, INC.] | 1 | |
| SODIUM CITRATE | INACTIVE INGREDIENT | 1Q73Q2JULR | PROMETHAZINE WITH CODEINE LIQUID [APOTHECA, INC.] | 1 | |
| SODIUM PROPIONATE | INACTIVE INGREDIENT | DK6Y9P42IN | PROMETHAZINE WITH CODEINE LIQUID [APOTHECA, INC.] | 1 | |
| SUCROSE | INACTIVE INGREDIENT | C151H8M554 | PROMETHAZINE WITH CODEINE LIQUID [APOTHECA, INC.] | 1 | |
| TRISODIUM CITRATE DIHYDRATE | INACTIVE INGREDIENT | B22547B95K | PROMETHAZINE WITH CODEINE LIQUID [APOTHECA, INC.] | 1 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | PROMETHAZINE WITH CODEINE LIQUID [APOTHECA, INC.] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 12634-909 | PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE SYRUP [APOTHECA INC] | 5 | Legacy NDC, 7 package rows | 20170327_47d4eb4f-6dd4-44b9-aea1-19c4bfc1d425.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Status |
|---|
| 12634-909-02 | 12634090902 | 60 mL in 1 BOTTLE | 60 ml | Historical |
| 12634-909-04 | 12634090904 | 120 mL in 1 BOTTLE | 120 ml | Historical |
| 12634-909-06 | 12634090906 | 178 mL in 1 BOTTLE | 178 ml | Historical |
| 12634-909-08 | 12634090908 | 237 mL in 1 BOTTLE | 237 ml | Historical |
| 12634-909-16 | 12634090916 | 473 mL in 1 BOTTLE | 473 ml | Historical |
| 12634-909-28 | 12634090928 | 3785 mL in 1 BOTTLE | 3785 ml | Historical |
| 12634-909-32 | 12634090932 | 946 mL in 1 BOTTLE | 946 ml | Historical |