sprintec

Generic: norgestimate and ethinyl estradiol

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

Drug Facts

Product Profile

Brand Name sprintec
Generic Name norgestimate and ethinyl estradiol
Labeler teva pharmaceuticals usa, inc.
Dosage Form KIT
Manufacturer
Teva Pharmaceuticals USA, Inc.

Identifiers & Regulatory

Product NDC 0555-9016
Product ID 0555-9016_a12a68e8-a8fe-4ce5-aa31-b3366c470150
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA075804
Listing Expiration 2026-12-31
Marketing Start 2002-09-26

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 05559016
Hyphenated Format 0555-9016

Supplemental Identifiers

RxCUI
240128 748797 749860 753481

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 sprintec (source: ndc)
Generic Name norgestimate and ethinyl estradiol (source: ndc)
Application Number ANDA075804 (source: ndc)

Resolved Composition

Strengths
  • 0.250 mg
  • 0.035 mg
source: label
Packaging
  • 6 POUCH in 1 CARTON (0555-9016-58) / 1 BLISTER PACK in 1 POUCH / 1 KIT in 1 BLISTER PACK
source: ndc

Packages (1)

0555-9016-58 6 POUCH in 1 CARTON (0555-9016-58) / 1 BLISTER PACK in 1 POUCH / 1 KIT in 1 BLISTER PACK

Ingredients (0)

No ingredient records.

Linked Drug Pages (1)

Sprintec ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"spl_id": "a12a68e8-a8fe-4ce5-aa31-b3366c470150", "openfda": {"rxcui": ["240128", "748797", "749860", "753481"], "spl_set_id": ["d9252820-131a-4870-8b11-945d1bfd5659"], "manufacturer_name": ["Teva Pharmaceuticals USA, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "6 POUCH in 1 CARTON (0555-9016-58)  / 1 BLISTER PACK in 1 POUCH / 1 KIT in 1 BLISTER PACK", "package_ndc": "0555-9016-58", "marketing_start_date": "20020926"}], "brand_name": "Sprintec", "product_id": "0555-9016_a12a68e8-a8fe-4ce5-aa31-b3366c470150", "dosage_form": "KIT", "product_ndc": "0555-9016", "generic_name": "Norgestimate and Ethinyl Estradiol", "labeler_name": "Teva Pharmaceuticals USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Sprintec", "application_number": "ANDA075804", "marketing_category": "ANDA", "marketing_start_date": "20020926", "listing_expiration_date": "20261231"}