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NDC 45802-0009-10 Fluocinolone Acetonide 0.11 mg/mL Details
Fluocinolone Acetonide 0.11 mg/mL
Fluocinolone Acetonide is a AURICULAR (OTIC) SOLUTION/ DROPS in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Padagis Israel Pharmaceuticals Ltd. The primary component is FLUOCINOLONE ACETONIDE.
Product Information
NDC | 45802-0009 |
---|---|
Product ID | 45802-009_411adaf8-ab23-416a-b452-84ae6ee836e1 |
Associated GPIs | 87300018101720 |
GCN Sequence Number | 060055 |
GCN Sequence Number Description | fluocinolone acetonide oil DROPS 0.01 % OTIC (EAR) |
HIC3 | Q8P |
HIC3 Description | EAR PREPARATIONS ANTI-INFLAMMATORY |
GCN | 26056 |
HICL Sequence Number | 033338 |
HICL Sequence Number Description | FLUOCINOLONE ACETONIDE OIL |
Brand/Generic | Generic |
Proprietary Name | Fluocinolone Acetonide |
Proprietary Name Suffix | n/a |
Non-Proprietary Name | Fluocinolone Acetonide |
Product Type | HUMAN PRESCRIPTION DRUG |
Dosage Form | SOLUTION/ DROPS |
Route | AURICULAR (OTIC) |
Active Ingredient Strength | 0.11 |
Active Ingredient Units | mg/mL |
Substance Name | FLUOCINOLONE ACETONIDE |
Labeler Name | Padagis Israel Pharmaceuticals Ltd |
Pharmaceutical Class | Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC] |
DEA Schedule | n/a |
Marketing Category | ANDA |
Application Number | ANDA202849 |
Listing Certified Through | 2024-12-31 |
Package
NDC 45802-0009-10 (45802000910)
NDC Package Code | 45802-009-10 |
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Billing NDC | 45802000910 |
Package | 1 BOTTLE in 1 CARTON (45802-009-10) / 20 mL in 1 BOTTLE |
Marketing Start Date | 2017-10-04 |
NDC Exclude Flag | N |
Pricing Information | |
Price Per Unit | 1.31946 |
Pricing Unit | ML |
Effective Date | 2024-02-21 |
NDC Description | FLUOCINOLONE OIL 0.01% EAR DRP |
Pharmacy Type Indicator | C/I |
OTC | N |
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