Label: STIX RESTART- levonorgestrel tablet
- NDC Code(s): 80584-102-13
- Packager: Winx Health Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated June 19, 2024
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INGREDIENTS AND APPEARANCE
STIX RESTART
levonorgestrel tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:80584-102 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LEVONORGESTREL (UNII: 5W7SIA7YZW) (LEVONORGESTREL - UNII:5W7SIA7YZW) LEVONORGESTREL 1.5 mg Inactive Ingredients Ingredient Name Strength FD&C YELLOW NO. 6 (UNII: H77VEI93A8) MAGNESIUM STEARATE (UNII: 70097M6I30) TALC (UNII: 7SEV7J4R1U) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) STARCH, CORN (UNII: O8232NY3SJ) Product Characteristics Color orange (Light peach) Score no score Shape ROUND Size 8mm Flavor Imprint Code 17 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:80584-102-13 1 in 1 CARTON 01/01/2024 1 1 in 1 BLISTER PACK; Type 0: Not a Combination Product 
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA207660 09/13/2022 Labeler - Winx Health Inc. (117116737) Establishment Name Address ID/FEI Business Operations Naari Pharma Private Limited 915787058 manufacture(80584-102) , analysis(80584-102) , label(80584-102) , pack(80584-102)
