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NDC 63629-8655-01 fluocinolone acetonide 0.01 mg/100mL Details
fluocinolone acetonide 0.01 mg/100mL
fluocinolone acetonide is a TOPICAL OIL in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Bryant Ranch Prepack. The primary component is FLUOCINOLONE ACETONIDE.
Product Information
| NDC | 63629-8655 |
|---|---|
| Product ID | 63629-8655_00b82ca7-a375-f359-e063-6394a90a82a8 |
| Associated GPIs | |
| GCN Sequence Number | 007507 |
| GCN Sequence Number Description | fluocinolone acetonide OIL 0.01 % TOPICAL |
| HIC3 | Q5P |
| HIC3 Description | TOPICAL ANTI-INFLAMMATORY STEROIDAL |
| GCN | 85080 |
| HICL Sequence Number | 002896 |
| HICL Sequence Number Description | FLUOCINOLONE ACETONIDE |
| Brand/Generic | Generic |
| Proprietary Name | fluocinolone acetonide |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | fluocinolone acetonide |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | OIL |
| Route | TOPICAL |
| Active Ingredient Strength | 0.01 |
| Active Ingredient Units | mg/100mL |
| Substance Name | FLUOCINOLONE ACETONIDE |
| Labeler Name | Bryant Ranch Prepack |
| Pharmaceutical Class | Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA202847 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 63629-8655-01 (63629865501)
| NDC Package Code | 63629-8655-1 |
|---|---|
| Billing NDC | 63629865501 |
| Package | 1 BOTTLE in 1 CARTON (63629-8655-1) / 118.28 mL in 1 BOTTLE |
| Marketing Start Date | 2017-06-14 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |