Promethazine is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Pharmpak, Inc.. The primary component is Promethazine Hydrochloride.
| Product ID | 54348-117_8f7527b3-28b7-1871-e053-2995a90abfa6 |
| NDC | 54348-117 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Promethazine |
| Generic Name | Promethazine |
| Dosage Form | Tablet |
| Route of Administration | ORAL |
| Marketing Start Date | 2019-07-11 |
| Marketing Category | ANDA / ANDA |
| Application Number | ANDA040712 |
| Labeler Name | PharmPak, Inc. |
| Substance Name | PROMETHAZINE HYDROCHLORIDE |
| Active Ingredient Strength | 25 mg/1 |
| Pharm Classes | Phenothiazine [EPC],Phenothiazines [CS] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2020-12-31 |
| Marketing Start Date | 2019-07-11 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | ANDA |
| Application Number | ANDA040712 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2019-07-11 |
| Marketing Category | ANDA |
| Application Number | ANDA040712 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2019-07-11 |
| Marketing Category | ANDA |
| Application Number | ANDA040712 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2019-07-11 |
| Marketing Category | ANDA |
| Application Number | ANDA040712 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2019-07-11 |
| Marketing Category | ANDA |
| Application Number | ANDA040712 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2019-07-11 |
| Marketing Category | ANDA |
| Application Number | ANDA040712 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2019-07-11 |
| Marketing Category | ANDA |
| Application Number | ANDA040712 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2019-07-11 |
| Marketing Category | ANDA |
| Application Number | ANDA040712 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2019-07-11 |
| Marketing Category | ANDA |
| Application Number | ANDA040712 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2019-07-11 |
| Marketing Category | ANDA |
| Application Number | ANDA040712 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2019-07-11 |
| Ingredient | Strength |
|---|---|
| PROMETHAZINE HYDROCHLORIDE | 25 mg/1 |
| SPL SET ID: | 4f681538-7ac4-484c-9e6d-b571d73b9e0b |
| Manufacturer | |
| UNII |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 0615-1539 | Promethazine | Promethazine Hydrochloride |
| 43063-708 | Promethazine | Promethazine Hydrochloride |
| 54348-117 | Promethazine | PROMETHAZINE |
| 65162-678 | Promethazine Hydrochloride | Promethazine |