cryselle

Generic: norgestrel and ethinyl estradiol

Labeler: teva pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name cryselle
Generic Name norgestrel and ethinyl estradiol
Labeler teva pharmaceuticals, inc.
Dosage Form KIT
Routes
ORAL
Manufacturer
Teva Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 0480-3493
Product ID 0480-3493_6cb4094e-229d-480f-884f-40b4a4bb407b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA075840
Listing Expiration 2026-12-31
Marketing Start 2025-12-12

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 04803493
Hyphenated Format 0480-3493

Supplemental Identifiers

RxCUI
311359 748797 749786 750265

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 cryselle (source: ndc)
Generic Name norgestrel and ethinyl estradiol (source: ndc)
Application Number ANDA075840 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 0.3 mg/0.03 mg
source: label
Packaging
  • 6 POUCH in 1 CARTON (0480-3493-16) / 1 BLISTER PACK in 1 POUCH (0480-3493-24) / 1 KIT in 1 BLISTER PACK * 21 TABLET in 1 BLISTER PACK (0480-5793-11) * 7 TABLET in 1 BLISTER PACK (0480-5794-22)
source: ndc

Packages (1)

0480-3493-16 6 POUCH in 1 CARTON (0480-3493-16) / 1 BLISTER PACK in 1 POUCH (0480-3493-24) / 1 KIT in 1 BLISTER PACK * 21 TABLET in 1 BLISTER PACK (0480-5793-11) * 7 TABLET in 1 BLISTER PACK (0480-5794-22)

Ingredients (0)

No ingredient records.

Linked Drug Pages (1)

Cryselle ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "6cb4094e-229d-480f-884f-40b4a4bb407b", "openfda": {"rxcui": ["311359", "748797", "749786", "750265"], "spl_set_id": ["b5d48561-1aa1-4c9b-935f-6cf035225769"], "manufacturer_name": ["Teva Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "6 POUCH in 1 CARTON (0480-3493-16)  / 1 BLISTER PACK in 1 POUCH (0480-3493-24)  / 1 KIT in 1 BLISTER PACK *  21 TABLET in 1 BLISTER PACK (0480-5793-11)  *  7 TABLET in 1 BLISTER PACK (0480-5794-22)", "package_ndc": "0480-3493-16", "marketing_start_date": "20251212"}], "brand_name": "Cryselle", "product_id": "0480-3493_6cb4094e-229d-480f-884f-40b4a4bb407b", "dosage_form": "KIT", "product_ndc": "0480-3493", "generic_name": "Norgestrel and Ethinyl Estradiol", "labeler_name": "Teva Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Cryselle", "application_number": "ANDA075840", "marketing_category": "ANDA", "marketing_start_date": "20251212", "listing_expiration_date": "20261231"}