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NDC 70000-0025-01 Miconazole 3 Combination Pack Details
Miconazole 3 Combination Pack
Miconazole 3 Combination Pack is a VAGINAL KIT in the HUMAN OTC DRUG category. It is labeled and distributed by Cardinal Health (Leader) 70000. The primary component is .
MedlinePlus Drug Summary
Vaginal miconazole is used to treat vaginal yeast infections in adults and children 12 years of age and older. Miconazole is in a class of antifungal medications called imidazoles. It works by stopping the growth of fungi that cause infection.
Related Packages: 70000-0025-01Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Miconazole Vaginal
Product Information
| NDC | 70000-0025 |
|---|---|
| Product ID | 70000-0025_a6bb2a5b-bfd0-4738-b23f-346c21b494b5 |
| Associated GPIs | 55104050106410 |
| GCN Sequence Number | 007006 |
| GCN Sequence Number Description | miconazole nitrate KIT 200 MG-2 % VAGINAL |
| HIC3 | Q4F |
| HIC3 Description | VAGINAL ANTIFUNGALS |
| GCN | 69380 |
| HICL Sequence Number | 003031 |
| HICL Sequence Number Description | MICONAZOLE NITRATE |
| Brand/Generic | Generic |
| Proprietary Name | Miconazole 3 Combination Pack |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | miconazole nitrate |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | KIT |
| Route | VAGINAL |
| Active Ingredient Strength | n/a |
| Active Ingredient Units | n/a |
| Substance Name | n/a |
| Labeler Name | Cardinal Health (Leader) 70000 |
| Pharmaceutical Class | n/a |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA074926 |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 70000-0025-01 (70000002501)
| NDC Package Code | 70000-0025-1 |
|---|---|
| Billing NDC | 70000002501 |
| Package | 1 KIT in 1 PACKAGE, COMBINATION (70000-0025-1) * 3 SUPPOSITORY in 1 BLISTER PACK * 9 g in 1 TUBE |
| Marketing Start Date | 2019-07-01 |
| NDC Exclude Flag | N |
| Pricing Information | |
| Price Per Unit | 8.12647 |
| Pricing Unit | EA |
| Effective Date | 2024-01-17 |
| NDC Description | MICONAZOLE 3 COMBO PACK |
| Pharmacy Type Indicator | C/I |
| OTC | Y |
| Explanation Code | 4 |
| 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
Standard Product Labeling (SPL)/Prescribing Information SPL 70b69ca5-b5a4-425f-9e9d-6b560a9cc895 Details
Active ingredients
Uses
Warnings
For vaginal use only
Ask a doctor before use if you have
- vaginal itching and discomfort for the first time
- lower abdominal, back or shoulder pain, fever, chills, nausea, vomiting, or foul-smelling vaginal discharge. You may have a more serious condition.
- vaginal yeast infections often (such as once a month or 3 in 6 months). You could be pregnant or have a serious underlying medical cause for your symptoms, including diabetes or a weakened immune system.
- been exposed to the human immunodeficiency virus (HIV) that causes AIDS
Ask a doctor or pharmacist before use if you are
taking the prescription blood thinning medicine, warfarin, because bleeding and bruising may occur.
When using this product
- do not use tampons, douches, spermicides or other vaginal products. Condoms and diaphragms may be damaged and fail to prevent pregnancy or sexually transmitted diseases (STDs).
- do not have vaginal intercourse
- mild increase in vaginal burning, itching or irritation may occur.
Directions
- before using this product read the enclosed consumer information leaflet for complete directions and information
-
adults and children 12 years of age and over:
- suppositories: insert 1 suppository into the vagina at bedtime for 3 nights in a row. Wash applicator after each use.
- external cream: Use cap to puncture seal. Squeeze a small amount of cream onto your fingertip. Apply the cream onto the itchy, irritated skin outside the vagina. Use 2 times daily for up to 7 days, as needed.
- children under 12 years of age: ask a doctor
Other information
- do not use if suppository wrapper is missing or damaged (each suppository is individually wrapped)
- do not use if seal over tube opening has been punctured or is not visible
- do not purchase if carton is open
- store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature] excursions permitted to 15°-30°C (59°-86°F).
Inactive ingredients
Principal display panel
COMPARE TO MONISTAT® 3 active ingredient*
Miconazole 3
Combination ack
Miconazole Nitrate Vaginal Suppositories, SP 200 mg
and Miconazole Nitrate Vaginal Cream, USP 2%
Vaginal Antifungal
Cure Most Vaginal Yeast Infections
Relieves Associated External Itching and Irritation
3 Miconazole Nitrate Vaginal Suppositories, USP 200 mg with 3 Disposable Applicators Plus
1 Tube of Miconazole Nitrate Vaginal cream, USP 2%
*This product is not affiliated with, manufactured by or produced by the makers or owners of Monistat® 3
DISTRIBUTED BY
CARDINAL HEALTH
DUBLIN, OHIO 43017
INGREDIENTS AND APPEARANCE
| MICONAZOLE 3 COMBINATION PACK
miconazole nitrate kit |
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| Labeler - Cardinal Health (Leader) 70000 (063997360) |
Revised: 11/2022
Document Id: a6bb2a5b-bfd0-4738-b23f-346c21b494b5
Set id: 70b69ca5-b5a4-425f-9e9d-6b560a9cc895
Version: 6
Effective Time: 20221107