topcare miconazole 1

Generic: miconazole nitrate

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

Drug Facts

Product Profile

Brand Name topcare miconazole 1
Generic Name miconazole nitrate
Labeler topco associates llc
Dosage Form KIT
Manufacturer
Topco Associates LLC

Identifiers & Regulatory

Product NDC 36800-199
Product ID 36800-199_aae0dcb7-6128-4681-b2c0-12be5aff38a1
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA079114
Listing Expiration 2026-12-31
Marketing Start 2010-06-17

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 36800199
Hyphenated Format 36800-199

Supplemental Identifiers

RxCUI
992774 992775 998483 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 1 (source: ndc)
Generic Name miconazole nitrate (source: ndc)
Application Number ANDA079114 (source: ndc)

Resolved Composition

Strengths
  • 1200 mg
  • 2 %
source: label
Packaging
  • 1 KIT in 1 CARTON (36800-199-00) * 1 SUPPOSITORY in 1 BLISTER PACK * 9 g in 1 TUBE
source: ndc

Packages (1)

36800-199-00 1 KIT in 1 CARTON (36800-199-00) * 1 SUPPOSITORY in 1 BLISTER PACK * 9 g in 1 TUBE

Ingredients (0)

No ingredient records.

Linked Drug Pages (1)

topcare miconazole 1 ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"spl_id": "aae0dcb7-6128-4681-b2c0-12be5aff38a1", "openfda": {"rxcui": ["992774", "992775", "998483", "998540"], "spl_set_id": ["8138de63-c7e9-4b2c-a0e2-c62292a0b320"], "manufacturer_name": ["Topco Associates LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 KIT in 1 CARTON (36800-199-00)  *  1 SUPPOSITORY in 1 BLISTER PACK *  9 g in 1 TUBE", "package_ndc": "36800-199-00", "marketing_start_date": "20100617"}], "brand_name": "topcare miconazole 1", "product_id": "36800-199_aae0dcb7-6128-4681-b2c0-12be5aff38a1", "dosage_form": "KIT", "product_ndc": "36800-199", "generic_name": "Miconazole nitrate", "labeler_name": "Topco Associates LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "topcare miconazole 1", "application_number": "ANDA079114", "marketing_category": "ANDA", "marketing_start_date": "20100617", "listing_expiration_date": "20261231"}