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NDC 75834-0197-01 HYDROCORTISONE ACETATE PRAMOXINE HYDROCHLORIDE 25; 10 mg/g; mg/g Details
HYDROCORTISONE ACETATE PRAMOXINE HYDROCHLORIDE 25; 10 mg/g; mg/g
HYDROCORTISONE ACETATE PRAMOXINE HYDROCHLORIDE is a TOPICAL CREAM in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Nivagen Pharmaceuticals Inc.. The primary component is HYDROCORTISONE ACETATE; PRAMOXINE HYDROCHLORIDE.
MedlinePlus Drug Summary
Rectal hydrocortisone is used along with other medications to treat proctitis (swelling in the rectum) and ulcerative colitis (a condition which causes swelling and sores in the lining of the large intestine and rectum). It is also used to relieve itching and swelling from hemorrhoids and other rectal problems. Hydrocortisone is in a class of medications called corticosteroids. It works by activating natural substances in the skin to reduce swelling, redness, and itching.
Related Packages: 75834-0197-01Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Hydrocortisone Rectal
Pramoxine is used to temporarily relieve pain and itching from insect bites; poison ivy, poison oak, or poison sumac; minor cuts, scrapes, or burns; minor skin irritation or rashes; or dry, itchy skin. Pramoxine also may be used to treat soreness, burning, itching, and pain from hemorrhoids (''piles'') and other minor rectal irritations or itching. Pramoxine is in a class of medications called topical anesthetics. It works by stopping nerves from sending pain signals.
Related Packages: 75834-0197-01Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Pramoxine
Product Information
| NDC | 75834-0197 |
|---|---|
| Product ID | 75834-197_53ac723b-1f67-47e5-b560-6589342a27d8 |
| Associated GPIs | 89991002313720 |
| GCN Sequence Number | 034347 |
| GCN Sequence Number Description | hydrocortisone/pramoxine CREAM/APPL 2.5 %-1 % RECTAL |
| HIC3 | Q3I |
| HIC3 Description | HEMORRHOID PREP,ANTI-INFLAM STEROID-LOCAL ANESTHET |
| GCN | 84133 |
| HICL Sequence Number | 015163 |
| HICL Sequence Number Description | HYDROCORTISONE ACETATE/PRAMOXINE HCL |
| Brand/Generic | Generic |
| Proprietary Name | HYDROCORTISONE ACETATE PRAMOXINE HYDROCHLORIDE |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | PRAMOXINE HYDROCHLORIDE and HYDROCORTISONE ACETATE |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | CREAM |
| Route | TOPICAL |
| Active Ingredient Strength | 25; 10 |
| Active Ingredient Units | mg/g; mg/g |
| Substance Name | HYDROCORTISONE ACETATE; PRAMOXINE HYDROCHLORIDE |
| Labeler Name | Nivagen Pharmaceuticals Inc. |
| Pharmaceutical Class | Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC] |
| DEA Schedule | n/a |
| Marketing Category | UNAPPROVED DRUG OTHER |
| Application Number | n/a |
| Listing Certified Through | 2024-12-31 |
Package
NDC 75834-0197-01 (75834019701)
| NDC Package Code | 75834-197-01 |
|---|---|
| Billing NDC | 75834019701 |
| Package | 1 TUBE, WITH APPLICATOR in 1 CARTON (75834-197-01) / 28.5 g in 1 TUBE, WITH APPLICATOR |
| Marketing Start Date | 2019-04-29 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |