introvale

Generic: levonorgestrel and ethinyl estradiol tablets

Labeler: xiromed llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name introvale
Generic Name levonorgestrel and ethinyl estradiol tablets
Labeler xiromed llc
Dosage Form KIT
Manufacturer
Xiromed LLC

Identifiers & Regulatory

Product NDC 70700-208
Product ID 70700-208_afa14bda-c9ec-485c-527a-622d0afb457a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA200490
Listing Expiration 2026-12-31
Marketing Start 2025-01-29

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 70700208
Hyphenated Format 70700-208

Supplemental Identifiers

RxCUI
238019 748797 751901 1020155

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 introvale (source: ndc)
Generic Name levonorgestrel and ethinyl estradiol tablets (source: ndc)
Application Number ANDA200490 (source: ndc)

Resolved Composition

Strengths
  • 0.15 mg
  • 0.03 mg
  • 0.15 mg/0.03 mg
source: label
Packaging
  • 3 POUCH in 1 CARTON (70700-208-88) / 1 BLISTER PACK in 1 POUCH (70700-208-87) / 1 KIT in 1 BLISTER PACK
source: ndc

Packages (1)

70700-208-88 3 POUCH in 1 CARTON (70700-208-88) / 1 BLISTER PACK in 1 POUCH (70700-208-87) / 1 KIT in 1 BLISTER PACK

Ingredients (0)

No ingredient records.

Linked Drug Pages (1)

INTROVALE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"spl_id": "afa14bda-c9ec-485c-527a-622d0afb457a", "openfda": {"rxcui": ["238019", "748797", "751901", "1020155"], "spl_set_id": ["24abb5e1-5be4-87e7-404c-d8c2db25ffd0"], "manufacturer_name": ["Xiromed LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "3 POUCH in 1 CARTON (70700-208-88)  / 1 BLISTER PACK in 1 POUCH (70700-208-87)  / 1 KIT in 1 BLISTER PACK", "package_ndc": "70700-208-88", "marketing_start_date": "20250129"}], "brand_name": "INTROVALE", "product_id": "70700-208_afa14bda-c9ec-485c-527a-622d0afb457a", "dosage_form": "KIT", "product_ndc": "70700-208", "generic_name": "Levonorgestrel and Ethinyl Estradiol tablets", "labeler_name": "Xiromed LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "INTROVALE", "application_number": "ANDA200490", "marketing_category": "ANDA", "marketing_start_date": "20250129", "listing_expiration_date": "20261231"}