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 |