FDA.reportPublic FDA data

NDC 50102-130-01 - CHATEAL

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
50102-130
Requested NDC
50102-130-01
Package NDCs from labels
50102-130-00, 50102-130-01, 50102-130-48, 50102-130-10, 50102-130-03
Manufacturer
Afaxys Pharma, LLC | Mylan Laboratories Limited
Effective date
2021-01-27
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
CHATEAL - Afaxys Pharma, LLC | Mylan Laboratories LimitedAfaxys Pharma, LLC | Mylan Laboratories Limited2021-01-27HUMAN PRESCRIPTION DRUG LABEL
Chateal® (Levonorgestrel and Ethinyl Estradiol Tablets, USP 0.15 mg/0.03 mg)RPK Pharmaceuticals, Inc.2020-12-15HUMAN PRESCRIPTION DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unitNational Council for Prescription Drug Programs2013-02-13Indexing - Billing Unit

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
50102-130-032023-02-24Chateal® (Levonorgestrel and Ethinyl Estradiol Tablets, USP 0.15 mg/0.03 mg)
50102-130-482023-02-24Chateal® (Levonorgestrel and Ethinyl Estradiol Tablets, USP 0.15 mg/0.03 mg)
50102-130-032023-01-30Chateal® (Levonorgestrel and Ethinyl Estradiol Tablets, USP 0.15 mg/0.03 mg)
50102-130-482023-01-30Chateal® (Levonorgestrel and Ethinyl Estradiol Tablets, USP 0.15 mg/0.03 mg)

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50102-130-00EA - Each50102-130dcb62401-8949-464e-ab16-85f9c6f4c40d12022-06-06
50102-130-01EA - Each50102-130b8bb767c-e280-45f7-828d-4a8aaae9c21c12013-02-13
50102-130-03EA - Each50102-13061c25f8e-2546-4292-98d9-3172853ce2f112017-09-11
50102-130-10EA - Each50102-1304a3fd139-d25f-40ed-939c-42f8b7d58d0e12017-09-11
50102-130-48EA - Each50102-1301a4669e5-b979-4386-ba8b-04d4f4b7e28e12013-02-13
50102-130-90EA - Each50102-1303536e405-15d6-482b-949b-31b922af726b12013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ETHINYL ESTRADIOLACTIVE INGREDIENT423D2T571UCHATEAL ( LEVONORGESTREL AND ETHINYL ESTRADIOL ) KIT [AFAXYS INC.]6
LEVONORGESTRELACTIVE INGREDIENT5W7SIA7YZWCHATEAL ( LEVONORGESTREL AND ETHINYL ESTRADIOL ) KIT [AFAXYS INC.]6
ETHINYL ESTRADIOLACTIVE MOIETY423D2T571UCHATEAL ( LEVONORGESTREL AND ETHINYL ESTRADIOL ) KIT [AFAXYS INC.]6
LEVONORGESTRELACTIVE MOIETY5W7SIA7YZWCHATEAL ( LEVONORGESTREL AND ETHINYL ESTRADIOL ) KIT [AFAXYS INC.]6
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDCHATEAL ( LEVONORGESTREL AND ETHINYL ESTRADIOL ) KIT [AFAXYS INC.]6
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTCHATEAL ( LEVONORGESTREL AND ETHINYL ESTRADIOL ) KIT [AFAXYS INC.]6
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCHATEAL ( LEVONORGESTREL AND ETHINYL ESTRADIOL ) KIT [AFAXYS INC.]6
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CHATEAL ( LEVONORGESTREL AND ETHINYL ESTRADIOL ) KIT [AFAXYS INC.]6
POLACRILIN POTASSIUMINACTIVE INGREDIENT0BZ5A00FQUCHATEAL ( LEVONORGESTREL AND ETHINYL ESTRADIOL ) KIT [AFAXYS INC.]6

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 6 of 6 · 104 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AfterPlanLEVONORGESTRELSUN PHARMACEUTICAL INDUSTRIES, INC.c30c7bc2-04fa-4590-96f5-5bcf4bba3f1a2018-10-26WarningsExact identifier
unii: 5W7SIA7YZW
Morning AfterLEVONORGESTRELRapha Pharmaceuticals, Inc.677aa953-3c30-4ce5-e053-2991aa0ab2b22018-03-15WarningsExact identifier
unii: 5W7SIA7YZW
LevonorgestrelLEVONORGESTRELNovel Laboratories, Inc.ac13a073-a33a-45f7-8483-eecc9190195f2017-09-15Exact identifier
unii: 5W7SIA7YZW
My WayLEVONORGESTRELLupin Pharmaceuticals,Inc.ec01077e-ac3c-424a-9edc-0854fe0a2e0d2016-06-17WarningsExact identifier
unii: 5W7SIA7YZW

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.