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NDC 69396-0003-20 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 TRIFECTA PHARMACEUTICALS USA LLC. 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: 69396-0003-20Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Hydrocortisone Topical
Product Information
| NDC | 69396-0003 |
|---|---|
| Product ID | 69396-003_f2769d17-818c-866d-e053-2995a90afa2c |
| 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 | TRIFECTA PHARMACEUTICALS USA LLC |
| 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
NDC 69396-0003-20 (69396000320)
| NDC Package Code | 69396-003-20 |
|---|---|
| Billing NDC | 69396000320 |
| Package | 1 TUBE in 1 BOX (69396-003-20) / 28.4 g in 1 TUBE |
| Marketing Start Date | 2017-06-15 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |