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 1 of 6 · 105 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Etonogestrel and Ethinyl Estradiol VaginalETONOGESTREL AND ETHINYL ESTRADIOL VAGINALAvKARE05e172aa-e18a-427b-e063-6294a90ae22f2026-09-09Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
LEVONORGESTRELLEVONORGESTRELYYBA CORP5a71b870-9a0a-7997-e063-6294a90a882c2026-09-01WarningsExact identifier
unii: 5W7SIA7YZW
SheWiseLEVONORGESTRELGLENMARK THERAPEUTICS INC., USA7be13a7e-b4ff-4fe1-82a6-f9914596d72a2026-07-15WarningsExact identifier
unii: 5W7SIA7YZW
LevonorgestrelLEVONORGESTRELGLENMARK THERAPEUTICS INC., USA07567b80-d8a1-41c0-95e4-33afa584bbc42026-07-15WarningsExact identifier
unii: 5W7SIA7YZW
Gwyn LoNORELGESTROMIN AND ETHINYL ESTRADIOLViatris Specialty LLCe92741f4-87fe-429f-b5b5-c558ed5f4fa92026-07-06Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
TwirlaLEVONORGESTREL/ETHINYL ESTRADIOLAgile Therapeutics, Inc.bcaf8db0-1750-425d-b008-255b5e7a9cc62026-06-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
unii: 5W7SIA7YZW
OPTION 2LEVONORGESTRELL. Perrigo Company7d7b9e61-9f3d-477d-b74d-b0cc725f9bba2026-06-25WarningsExact identifier
unii: 5W7SIA7YZW
LevonorgestrelLEVONORGESTRELRugby Laboratories076126e4-9d76-45cd-a86b-5b35c56b620a2026-05-13WarningsExact identifier
unii: 5W7SIA7YZW
LEADER Emergency Contraceptive LevonorgestrelLEVONORGESTRELCardinal Health 110, LLC. DBA Leaderd1e33615-0a98-4223-833d-843c758d9db72026-05-06WarningsExact identifier
unii: 5W7SIA7YZW
My ChoiceLEVONORGESTRELOHM LABORATORIES INC500d9418-69a8-f4f3-e063-6394a90a9b662026-04-22WarningsExact identifier
unii: 5W7SIA7YZW
norelgestromin and ethinyl estradiolNORELGESTROMIN AND ETHINYL ESTRADIOLZydus Pharmaceuticals USA Inc.10fa1458-c8ed-4197-922a-1ba7271d2b022026-04-16Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
norelgestromin and ethinyl estradiolNORELGESTROMIN AND ETHINYL ESTRADIOLZydus Lifesciences Limited7c2cc8ab-db6d-4a1c-ae74-e0ef27e2f3a92026-04-16Exact identifier
unii: 423D2T571U
Norethindrone Acetate and Ethinyl EstradiolNORETHINDRONE ACETATE AND ETHINYL ESTRADIOLA-S Medication Solutions38924c83-53aa-4279-8f0e-1a5d8f5fd8ad2026-03-26Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
Climara ProESTRADIOL AND LEVONORGESTRELBayer HealthCare Pharmaceuticals Inc.184d3092-7fc6-4375-816b-1ab06bb99cfd2026-03-26Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 5W7SIA7YZW
LEVONORGESTRELLEVONORGESTRELCamber Consumer Care Inc2e22d0c4-b308-4a02-b2b0-2c06fb91d1e52026-03-23WarningsExact identifier
unii: 5W7SIA7YZW
Junel FEJUNEL FEDirect_Rxea62a66e-d45d-11be-e053-2a95a90a78012026-03-17Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
SkylaLEVONORGESTRELBayer HealthCare Pharmaceuticals Inc.9f44ff35-e052-49cd-a1c2-0bfd87d493092026-03-04Warnings, Adverse reactionsExact identifier
unii: 5W7SIA7YZW
RestartLEVONORGESTRELWinx Health Inc.0cdf198e-c114-b9fa-e063-6294a90a566a2026-02-24WarningsExact identifier
unii: 5W7SIA7YZW
LevonorgestrelLEVONORGESTRELYYBA Corp49008f10-8a70-3c08-e063-6294a90a44a32026-02-03WarningsExact identifier
unii: 5W7SIA7YZW
Levonorgestrel and Ethinyl EstradiolLEVONORGESTREL AND ETHINYL ESTRADIOLGlenmark Pharmaceuticals Inc., USA44fbc5ae-5682-471f-a12a-955e8b4d233a2026-01-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
unii: 5W7SIA7YZW

Reported adverse events (FAERS/openFDA)#

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