topcare miconazole 3 combination pack

Generic: miconazole nitrate

Labeler: topco associates llc
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name topcare miconazole 3 combination pack
Generic Name miconazole nitrate
Labeler topco associates llc
Dosage Form KIT
Manufacturer
Topco Associates LLC

Identifiers & Regulatory

Product NDC 36800-081
Product ID 36800-081_28b14543-3ba9-4c9c-a9bd-a94d1ca3bc90
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA075329
Listing Expiration 2026-12-31
Marketing Start 2000-05-10

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 36800081
Hyphenated Format 36800-081

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 topcare miconazole 3 combination pack (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 (36800-081-00) * 3 BLISTER PACK in 1 KIT / 1 SUPPOSITORY in 1 BLISTER PACK * 1 TUBE in 1 KIT / 9 g in 1 TUBE
source: ndc

Packages (1)

36800-081-00 1 KIT in 1 CARTON (36800-081-00) * 3 BLISTER PACK in 1 KIT / 1 SUPPOSITORY in 1 BLISTER PACK * 1 TUBE in 1 KIT / 9 g in 1 TUBE

Ingredients (0)

No ingredient records.

Linked Drug Pages (1)

topcare miconazole 3 combination pack ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"spl_id": "28b14543-3ba9-4c9c-a9bd-a94d1ca3bc90", "openfda": {"rxcui": ["992765", "992766", "998540"], "spl_set_id": ["0af4c06a-aa79-48ab-9857-e0f56317d8f3"], "manufacturer_name": ["Topco Associates LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 KIT in 1 CARTON (36800-081-00)  *  3 BLISTER PACK in 1 KIT / 1 SUPPOSITORY in 1 BLISTER PACK *  1 TUBE in 1 KIT / 9 g in 1 TUBE", "package_ndc": "36800-081-00", "marketing_start_date": "20000510"}], "brand_name": "topcare miconazole 3 combination pack", "product_id": "36800-081_28b14543-3ba9-4c9c-a9bd-a94d1ca3bc90", "dosage_form": "KIT", "product_ndc": "36800-081", "generic_name": "Miconazole nitrate", "labeler_name": "Topco Associates LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "topcare miconazole 3", "brand_name_suffix": "combination pack", "application_number": "ANDA075329", "marketing_category": "ANDA", "marketing_start_date": "20000510", "listing_expiration_date": "20261231"}