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NDC 63629-8656-01 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 | 63629-8656 |
|---|---|
| Product ID | 63629-8656_00b82ca7-a39a-f359-e063-6394a90a82a8 |
| Associated GPIs | |
| GCN Sequence Number | 058950 |
| GCN Sequence Number Description | fluocinolone/shower cap OIL 0.01 % TOPICAL |
| HIC3 | Q5P |
| HIC3 Description | TOPICAL ANTI-INFLAMMATORY STEROIDAL |
| GCN | 24484 |
| HICL Sequence Number | 032834 |
| HICL Sequence Number Description | FLUOCINOLONE ACETONIDE/SHOWER CAP |
| 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 | ANDA202848 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 63629-8656-01 (63629865601)
| NDC Package Code | 63629-8656-1 |
|---|---|
| Billing NDC | 63629865601 |
| Package | 1 BOTTLE in 1 CARTON (63629-8656-1) / 118.28 mL in 1 BOTTLE |
| Marketing Start Date | 2017-06-14 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |