Promethazine and Phenylephrine HCl, and Codeine Phosphate
- Product NDC
- 65162-694
- 11-digit product format
- 651620694
- Labeler code
- 65162
- Product ID
- 65162-694_fa597180-cb04-48de-ba6c-1cc3781d7f31
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Promethazine, Phenylephrine, Codeine
- Dosage form
- SYRUP
- Route
- ORAL
- Labeler
- Amneal Pharmaceuticals LLC
- Application
- ANDA200963
- Marketing category
- ANDA
- Marketing start
- 2013-11-01
- Substance
- CODEINE PHOSPHATE; PHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE
- Active strength
- 10; 5; 6.25 mg/5mL; mg/5mL; mg/5mL
- Pharmacologic classes
- Adrenergic alpha1-Agonists [MoA], Full Opioid Agonists [MoA], Opioid Agonist [EPC], Phenothiazine [EPC], Phenothiazines [CS], alpha-1 Adrenergic Agonist [EPC]
- DEA schedule
- CV
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Promethazine and Phenylephrine HCl, and Codeine Phosphate
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| CODEINE PHOSPHATE | 10 mg/5mL |
| PHENYLEPHRINE HYDROCHLORIDE | 5 mg/5mL |
| PROMETHAZINE HYDROCHLORIDE | 6.25 mg/5mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | GSL05Y1MN6, 04JA59TNSJ, R61ZEH7I1I |
| Rxcui | 996757 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 65162-694-86 | Promethazine and Phenylephrine HCl, and Codeine Phosphate | 118 mL in 1 BOTTLE | SYRUP | 118 | | 36 |
| 65162-694-90 | Promethazine and Phenylephrine HCl, and Codeine Phosphate | 473 mL in 1 BOTTLE | SYRUP | 473 | | 36 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| CODEINE PHOSPHATE | ACTIVE INGREDIENT | GSL05Y1MN6 | PROMETHAZINE HCL, PHENYLEPHRINE HCL, CODEINE PHOSPHATE (PROMETHAZINE, PHENYLEPHRINE, CODEINE) SYRUP [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 10 | |
| PHENYLEPHRINE HYDROCHLORIDE | ACTIVE INGREDIENT | 04JA59TNSJ | PROMETHAZINE HCL, PHENYLEPHRINE HCL, CODEINE PHOSPHATE (PROMETHAZINE, PHENYLEPHRINE, CODEINE) SYRUP [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 10 | |
| PROMETHAZINE HYDROCHLORIDE | ACTIVE INGREDIENT | R61ZEH7I1I | PROMETHAZINE HCL, PHENYLEPHRINE HCL, CODEINE PHOSPHATE (PROMETHAZINE, PHENYLEPHRINE, CODEINE) SYRUP [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 10 | |
| CODEINE ANHYDROUS | ACTIVE MOIETY | UX6OWY2V7J | PROMETHAZINE HCL, PHENYLEPHRINE HCL, CODEINE PHOSPHATE (PROMETHAZINE, PHENYLEPHRINE, CODEINE) SYRUP [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 10 | |
| PHENYLEPHRINE | ACTIVE MOIETY | 1WS297W6MV | PROMETHAZINE HCL, PHENYLEPHRINE HCL, CODEINE PHOSPHATE (PROMETHAZINE, PHENYLEPHRINE, CODEINE) SYRUP [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 10 | |
| PROMETHAZINE | ACTIVE MOIETY | FF28EJQ494 | PROMETHAZINE HCL, PHENYLEPHRINE HCL, CODEINE PHOSPHATE (PROMETHAZINE, PHENYLEPHRINE, CODEINE) SYRUP [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 10 | |
| ANHYDROUS CITRIC ACID | INACTIVE INGREDIENT | XF417D3PSL | PROMETHAZINE HCL, PHENYLEPHRINE HCL, CODEINE PHOSPHATE (PROMETHAZINE, PHENYLEPHRINE, CODEINE) SYRUP [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 10 | |
| ASCORBIC ACID | INACTIVE INGREDIENT | PQ6CK8PD0R | PROMETHAZINE HCL, PHENYLEPHRINE HCL, CODEINE PHOSPHATE (PROMETHAZINE, PHENYLEPHRINE, CODEINE) SYRUP [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 10 | |
| EDETATE DISODIUM | INACTIVE INGREDIENT | 7FLD91C86K | PROMETHAZINE HCL, PHENYLEPHRINE HCL, CODEINE PHOSPHATE (PROMETHAZINE, PHENYLEPHRINE, CODEINE) SYRUP [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 10 | |
| GLYCERIN | INACTIVE INGREDIENT | PDC6A3C0OX | PROMETHAZINE HCL, PHENYLEPHRINE HCL, CODEINE PHOSPHATE (PROMETHAZINE, PHENYLEPHRINE, CODEINE) SYRUP [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 10 | |
| METHYLPARABEN | INACTIVE INGREDIENT | A2I8C7HI9T | PROMETHAZINE HCL, PHENYLEPHRINE HCL, CODEINE PHOSPHATE (PROMETHAZINE, PHENYLEPHRINE, CODEINE) SYRUP [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 10 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | PROMETHAZINE HCL, PHENYLEPHRINE HCL, CODEINE PHOSPHATE (PROMETHAZINE, PHENYLEPHRINE, CODEINE) SYRUP [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 10 | |
| SACCHARIN SODIUM | INACTIVE INGREDIENT | SB8ZUX40TY | PROMETHAZINE HCL, PHENYLEPHRINE HCL, CODEINE PHOSPHATE (PROMETHAZINE, PHENYLEPHRINE, CODEINE) SYRUP [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 10 | |
| SODIUM BENZOATE | INACTIVE INGREDIENT | OJ245FE5EU | PROMETHAZINE HCL, PHENYLEPHRINE HCL, CODEINE PHOSPHATE (PROMETHAZINE, PHENYLEPHRINE, CODEINE) SYRUP [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 10 | |
| SODIUM CITRATE, UNSPECIFIED FORM | INACTIVE INGREDIENT | 1Q73Q2JULR | PROMETHAZINE HCL, PHENYLEPHRINE HCL, CODEINE PHOSPHATE (PROMETHAZINE, PHENYLEPHRINE, CODEINE) SYRUP [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 10 | |
| SODIUM METABISULFITE | INACTIVE INGREDIENT | 4VON5FNS3C | PROMETHAZINE HCL, PHENYLEPHRINE HCL, CODEINE PHOSPHATE (PROMETHAZINE, PHENYLEPHRINE, CODEINE) SYRUP [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 10 | |
| SUCROSE | INACTIVE INGREDIENT | C151H8M554 | PROMETHAZINE HCL, PHENYLEPHRINE HCL, CODEINE PHOSPHATE (PROMETHAZINE, PHENYLEPHRINE, CODEINE) SYRUP [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 10 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | PROMETHAZINE HCL, PHENYLEPHRINE HCL, CODEINE PHOSPHATE (PROMETHAZINE, PHENYLEPHRINE, CODEINE) SYRUP [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 10 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 65162-694 | PROMETHAZINE HCL, PHENYLEPHRINE HCL, CODEINE PHOSPHATE (PROMETHAZINE, PHENYLEPHRINE, CODEINE) SYRUP [AMNEAL PHARMACEUTICALS LLC] | 30 | Current NDC, Legacy NDC, 2 package rows | 20240215_5f23b254-872b-4e88-91be-710c3ea7687b.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 |
|---|
| 65162-694-86 | 65162069486 | 118 mL in 1 BOTTLE (65162-694-86) | 118 ml | 2013-11-01 | 0000-00-00 | No | No | Current |
| 65162-694-90 | 65162069490 | 473 mL in 1 BOTTLE (65162-694-90) | 473 ml | 2013-11-01 | 0000-00-00 | No | No | Current |