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NDC 49348-0833-61 Miconazole 7 100 mg/1 Details
Miconazole 7 100 mg/1
Miconazole 7 is a VAGINAL SUPPOSITORY in the HUMAN OTC DRUG category. It is labeled and distributed by Strategic Sourcing Services LLC. The primary component is MICONAZOLE NITRATE.
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: 49348-0833-61Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Miconazole Vaginal
Product Information
NDC | 49348-0833 |
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Product ID | 49348-833_6e7caa6d-bb98-4586-8a0b-998afb5744da |
Associated GPIs | 55104050105205 |
GCN Sequence Number | 007004 |
GCN Sequence Number Description | miconazole nitrate SUPP.VAG 100 MG VAGINAL |
HIC3 | Q4F |
HIC3 Description | VAGINAL ANTIFUNGALS |
GCN | 28390 |
HICL Sequence Number | 003031 |
HICL Sequence Number Description | MICONAZOLE NITRATE |
Brand/Generic | Generic |
Proprietary Name | Miconazole 7 |
Proprietary Name Suffix | n/a |
Non-Proprietary Name | Miconazole Nitrate |
Product Type | HUMAN OTC DRUG |
Dosage Form | SUPPOSITORY |
Route | VAGINAL |
Active Ingredient Strength | 100 |
Active Ingredient Units | mg/1 |
Substance Name | MICONAZOLE NITRATE |
Labeler Name | Strategic Sourcing Services LLC |
Pharmaceutical Class | Azole Antifungal [EPC], Azoles [CS] |
DEA Schedule | n/a |
Marketing Category | ANDA |
Application Number | ANDA073507 |
Listing Certified Through | 2024-12-31 |
Package
Package Images

NDC 49348-0833-61 (49348083361)
NDC Package Code | 49348-833-61 |
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Billing NDC | 49348083361 |
Package | 7 SUPPOSITORY in 1 APPLICATOR (49348-833-61) |
Marketing Start Date | 2011-12-09 |
NDC Exclude Flag | N |
Pricing Information | |
Price Per Unit | 1.1331 |
Pricing Unit | EA |
Effective Date | 2023-04-19 |
NDC Description | SM MICONAZOLE 7 100 MG VAG SUP |
Pharmacy Type Indicator | C/I |
OTC | Y |
Explanation Code | 4 |
Classification for Rate Setting | G |
As of Date | 2024-02-21 |
Standard Product Labeling (SPL)/Prescribing Information SPL 89132802-beb1-42f4-8da4-39918fc5c4dd Details
Warnings
For vaginal use only
Ask a doctor before use if you have
- vaginal itching and discomfort for the first time
- vaginal yeast infections often (such as once a month or 3 in 6 months). You may have a more serious condition. You could be pregnant or have a medical condition, such as diabetes or a weakened immune system.
- lower abdominal, back, or shoulder pain, fever, chills, nausea, vomiting, or foul-smelling vaginal discharge
- been exposed to the human immunodeficiency virus (HIV) that causes AIDS
Ask a doctor or pharmacist before use if you are
taking a prescription blood thinning medicine, such as warfarin, because bleeding or bruising may occur
When using this product
- do not use tampons, douches, spermicides or other vaginal products
- do not use condoms or diaphragms. They may be damaged by this product and not prevent pregnancy or sexually transmitted diseases (STDs).
- do not have vaginal intercourse (sex)
- mild increase in vaginal burning, itching or irritation may occur
Directions
Other information
Principal display panel
COMPARETO MONISTAT® 7 ACTIVE INGREDIENT*
miconazole 7
Vaginal Suppositories
Miconazole Nitrate Vaginal
Suppositories, USP 100 mg
Vaginal antifungal
Cures most vaginal yeast infections
7 VAGINAL SUPPOSITORIES WITH 1 REUSABLE PLASTIC APPLICATOR
*This product is not affiliated with, manufactured by, or produced by the makers or owners of Monistat®
Distributed by McKesson Corp.,
via Strategic Sourcing Services LLC,
Memphis, TN 38141
INGREDIENTS AND APPEARANCE
MICONAZOLE 7
miconazole nitrate suppository |
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Labeler - Strategic Sourcing Services LLC (116956644) |