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NDC 00168-0416-99 Tacrolimus 1 mg/g Details
Tacrolimus 1 mg/g
Tacrolimus is a TOPICAL OINTMENT in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.. The primary component is TACROLIMUS.
MedlinePlus Drug Summary
Tacrolimus ointment is used to treat the symptoms of eczema (atopic dermatitis; a skin disease that causes the skin to be dry and itchy and to sometimes develop red, scaly rashes) in patients who cannot use other medications for their condition or whose eczema has not responded to another medication. Tacrolimus is in a class of medications called topical calcineurin inhibitors. It works by stopping the immune system from producing substances that may cause eczema.
Related Packages: 00168-0416-99Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Tacrolimus Topical
Product Information
| NDC | 00168-0416 |
|---|---|
| Product ID | 0168-0416_7ea94e22-7c5a-4949-87dc-872bbecde0c4 |
| Associated GPIs | 90784075004230 |
| GCN Sequence Number | 047347 |
| GCN Sequence Number Description | tacrolimus OINT. (G) 0.1 % TOPICAL |
| HIC3 | Q5K |
| HIC3 Description | TOPICAL IMMUNOSUPPRESSIVE AGENTS |
| GCN | 12302 |
| HICL Sequence Number | 020974 |
| HICL Sequence Number Description | TACROLIMUS |
| Brand/Generic | Generic |
| Proprietary Name | Tacrolimus |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | tacrolimus |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | OINTMENT |
| Route | TOPICAL |
| Active Ingredient Strength | 1 |
| Active Ingredient Units | mg/g |
| Substance Name | TACROLIMUS |
| Labeler Name | E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. |
| Pharmaceutical Class | Calcineurin Inhibitor Immunosuppressant [EPC], Calcineurin Inhibitors [MoA] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA200744 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 00168-0416-99 (00168041699)
| NDC Package Code | 0168-0416-99 |
|---|---|
| Billing NDC | 00168041699 |
| Package | 1 TUBE in 1 CARTON (0168-0416-99) / 100 g in 1 TUBE |
| Marketing Start Date | 2014-09-09 |
| NDC Exclude Flag | N |
| Pricing Information | |
| Price Per Unit | 1.44697 |
| Pricing Unit | GM |
| Effective Date | 2024-02-21 |
| NDC Description | TACROLIMUS 0.1% OINTMENT |
| 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
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