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NDC 51672-2018-02 Hydrocortisone 1 g/100g Details
Hydrocortisone 1 g/100g
Hydrocortisone is a TOPICAL OINTMENT in the HUMAN OTC DRUG category. It is labeled and distributed by Taro Pharmaceuticals U.S.A., Inc.. The primary component is HYDROCORTISONE.
MedlinePlus Drug Summary
Hydrocortisone topical is used to treat redness, swelling, itching, and discomfort of various skin conditions. 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: 51672-2018-02Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Hydrocortisone Topical
Product Information
| NDC | 51672-2018 |
|---|---|
| Product ID | 51672-2018_d97e0037-cd87-4bb2-8f28-aa384b685cd6 |
| Associated GPIs | 90550075004210 |
| GCN Sequence Number | 007547 |
| GCN Sequence Number Description | hydrocortisone OINT. (G) 1 % TOPICAL |
| HIC3 | Q5P |
| HIC3 Description | TOPICAL ANTI-INFLAMMATORY STEROIDAL |
| GCN | 30951 |
| HICL Sequence Number | 002867 |
| HICL Sequence Number Description | HYDROCORTISONE |
| Brand/Generic | Generic |
| Proprietary Name | Hydrocortisone |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Hydrocortisone |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | OINTMENT |
| Route | TOPICAL |
| Active Ingredient Strength | 1 |
| Active Ingredient Units | g/100g |
| Substance Name | HYDROCORTISONE |
| Labeler Name | Taro Pharmaceuticals U.S.A., Inc. |
| Pharmaceutical Class | Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC] |
| DEA Schedule | n/a |
| Marketing Category | OTC MONOGRAPH NOT FINAL |
| Application Number | part348 |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 51672-2018-02 (51672201802)
| NDC Package Code | 51672-2018-2 |
|---|---|
| Billing NDC | 51672201802 |
| Package | 1 TUBE in 1 CARTON (51672-2018-2) / 28.4 g in 1 TUBE |
| Marketing Start Date | 1989-10-03 |
| NDC Exclude Flag | N |
| Pricing Information | |
| Price Per Unit | 0.07441 |
| Pricing Unit | GM |
| Effective Date | 2024-02-21 |
| NDC Description | HYDROCORTISONE 1% OINTMENT |
| Pharmacy Type Indicator | C/I |
| OTC | Y |
| Explanation Code | 1, 5 |
| Classification for Rate Setting | G |
| As of Date | 2024-02-21 |
This pricing file, entitled the NADAC (National Average Drug Acquisition
Cost) files, provide
state Medicaid agencies with covered outpatient drug prices by averaging
survey invoice
prices from retail community pharmacies across the United States. These
pharmacies include
independent retail community pharmacies and chain pharmacies. The prices
are updated on a
weekly and monthly basis
Standard Product Labeling (SPL)/Prescribing Information SPL f7aecfb4-c194-4554-8d05-4e46005e654b Details
Uses
- temporary relief of itching associated with minor skin irritations and rashes due to
- eczema
- insect bites
- poison ivy, poison oak, or poison sumac
- soaps
- detergents
- cosmetics
- jewelry
- seborrheic dermatitis
- psoriasis
- external genital and anal itching
- other uses of this product should be only under the advice and supervision of a doctor
Warnings
For external use only
Do not use
- in the eyes
- by putting this product into the rectum by using fingers or any mechanical device or applicator
Directions
Adults and children 2 years of age and older:
- apply to affected area not more than 3 to 4 times daily
Children under 2 years of age: do not use. consult a doctor
For external anal itching:
- Adults: when practical, cleanse the affected area with mild soap and warm water and rinse thoroughly
- gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product
Children under 12 years of age: consult a doctor
Other information
PRINCIPAL DISPLAY PANEL - 28.4 g Tube Carton
INGREDIENTS AND APPEARANCE
| HYDROCORTISONE
hydrocortisone ointment |
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| Labeler - Taro Pharmaceuticals U.S.A., Inc. (145186370) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Taro Pharmaceuticals Inc. | 206263295 | MANUFACTURE(51672-2018) | |
Revised: 1/2020
Document Id: d97e0037-cd87-4bb2-8f28-aa384b685cd6
Set id: f7aecfb4-c194-4554-8d05-4e46005e654b
Version: 2
Effective Time: 20200127