miconazole 3

Generic: miconazole nitrate

Labeler: cvs woonsocket prescription center, incorporated
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name miconazole 3
Generic Name miconazole nitrate
Labeler cvs woonsocket prescription center, incorporated
Dosage Form KIT
Manufacturer
CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED

Identifiers & Regulatory

Product NDC 51316-689
Product ID 51316-689_e55b2ee9-0e90-4788-88b1-ff25dc81b1ce
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA075329
Listing Expiration 2026-12-31
Marketing Start 2024-04-17

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 51316689
Hyphenated Format 51316-689

Supplemental Identifiers

RxCUI
992765 992766 998540

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name miconazole 3 (source: ndc)
Generic Name miconazole nitrate (source: ndc)
Application Number ANDA075329 (source: ndc)

Resolved Composition

Strengths
  • 200 mg
  • 2 %
source: label
Packaging
  • 1 KIT in 1 CARTON (51316-689-00) * 3 BLISTER PACK in 1 KIT (0113-6650-00) / 1 SUPPOSITORY in 1 BLISTER PACK * 1 TUBE in 1 KIT (0113-8123-00) / 9 g in 1 TUBE
source: ndc

Packages (1)

51316-689-00 1 KIT in 1 CARTON (51316-689-00) * 3 BLISTER PACK in 1 KIT (0113-6650-00) / 1 SUPPOSITORY in 1 BLISTER PACK * 1 TUBE in 1 KIT (0113-8123-00) / 9 g in 1 TUBE

Ingredients (0)

No ingredient records.

Linked Drug Pages (1)

Miconazole 3 ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"spl_id": "e55b2ee9-0e90-4788-88b1-ff25dc81b1ce", "openfda": {"rxcui": ["992765", "992766", "998540"], "spl_set_id": ["689ad530-48f9-4044-baa3-4f8b0657aeef"], "manufacturer_name": ["CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 KIT in 1 CARTON (51316-689-00)  *  3 BLISTER PACK in 1 KIT (0113-6650-00)  / 1 SUPPOSITORY in 1 BLISTER PACK *  1 TUBE in 1 KIT (0113-8123-00)  / 9 g in 1 TUBE", "package_ndc": "51316-689-00", "marketing_start_date": "20240417"}], "brand_name": "Miconazole 3", "product_id": "51316-689_e55b2ee9-0e90-4788-88b1-ff25dc81b1ce", "dosage_form": "KIT", "product_ndc": "51316-689", "generic_name": "Miconazole nitrate", "labeler_name": "CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Miconazole 3", "application_number": "ANDA075329", "marketing_category": "ANDA", "marketing_start_date": "20240417", "listing_expiration_date": "20261231"}