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NDC 00316-0193-30 Hydrocortisone 25 mg/g Details
Hydrocortisone 25 mg/g
Hydrocortisone is a TOPICAL CREAM in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Crown Laboratories. 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: 00316-0193-30Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Hydrocortisone Topical
Product Information
| NDC | 00316-0193 |
|---|---|
| Product ID | 0316-0193_087b5751-4553-c71c-e063-6394a90ac98f |
| Associated GPIs | 90550075003725 |
| GCN Sequence Number | 007545 |
| GCN Sequence Number Description | hydrocortisone CREAM (G) 2.5 % TOPICAL |
| HIC3 | Q5P |
| HIC3 Description | TOPICAL ANTI-INFLAMMATORY STEROIDAL |
| GCN | 30943 |
| 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 PRESCRIPTION DRUG |
| Dosage Form | CREAM |
| Route | TOPICAL |
| Active Ingredient Strength | 25 |
| Active Ingredient Units | mg/g |
| Substance Name | HYDROCORTISONE |
| Labeler Name | Crown Laboratories |
| Pharmaceutical Class | Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA080706 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 00316-0193-30 (00316019330)
| NDC Package Code | 0316-0193-30 |
|---|---|
| Billing NDC | 00316019330 |
| Package | 1 TUBE in 1 CARTON (0316-0193-30) / 30 g in 1 TUBE |
| Marketing Start Date | 2016-01-06 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |