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NDC 10135-0495-10 Promethazine Hydrochloride 25 mg/1 Details
Promethazine Hydrochloride 25 mg/1
Promethazine Hydrochloride is a ORAL TABLET in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Marlex Pharmaceuticals Inc. The primary component is PROMETHAZINE HYDROCHLORIDE.
MedlinePlus Drug Summary
Promethazine is used to relieve the symptoms of allergic reactions such as allergic rhinitis (runny nose and watery eyes caused by allergy to pollen, mold or dust), allergic conjunctivitis (red, watery eyes caused by allergies), allergic skin reactions, and allergic reactions to blood or plasma products. Promethazine is used with other medications to treat anaphylaxis (sudden, severe allergic reactions) and the symptoms of the common cold such as sneezing, cough, and runny nose. Promethazine is also used to relax and sedate patients before and after surgery, during labor, and at other times. Promethazine is also used to prevent and control nausea and vomiting that may occur after surgery, and with other medications to help relieve pain after surgery. Promethazine is also used to prevent and treat motion sickness. Promethazine helps control symptoms, but will not treat the cause of the symptoms or speed recovery. Promethazine is in a class of medications called phenothiazines. It works by blocking the action of a certain natural substance in the body.
Related Packages: 10135-0495-10Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Promethazine
Product Information
| NDC | 10135-0495 |
|---|---|
| Product ID | 10135-495_0ac13914-954c-5a36-e063-6294a90a36c9 |
| Associated GPIs | 41400020100310 |
| GCN Sequence Number | 003878 |
| GCN Sequence Number Description | promethazine HCl TABLET 25 MG ORAL |
| HIC3 | Z2P |
| HIC3 Description | ANTIHISTAMINES - 1ST GENERATION |
| GCN | 15043 |
| HICL Sequence Number | 012014 |
| HICL Sequence Number Description | PROMETHAZINE HCL |
| Brand/Generic | Generic |
| Proprietary Name | Promethazine Hydrochloride |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | promethazine hydrochloride |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | TABLET |
| Route | ORAL |
| Active Ingredient Strength | 25 |
| Active Ingredient Units | mg/1 |
| Substance Name | PROMETHAZINE HYDROCHLORIDE |
| Labeler Name | Marlex Pharmaceuticals Inc |
| Pharmaceutical Class | Phenothiazine [EPC], Phenothiazines [CS] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA091179 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 10135-0495-10 (10135049510)
| NDC Package Code | 10135-495-10 |
|---|---|
| Billing NDC | 10135049510 |
| Package | 1000 TABLET in 1 BOTTLE (10135-495-10) |
| Marketing Start Date | 2016-10-01 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |