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 4 of 6 · 104 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LevonorgestrelLEVONORGESTRELOhm Laboratories Inc.5c509934-8c11-4d7f-8506-5971c37cfc222024-09-06WarningsExact identifier
unii: 5W7SIA7YZW
Etonogestrel and Ethinyl Estradiol Vaginal RingETONOGESTREL AND ETHINYL ESTRADIOL VAGINAL RINGNorthstar Rx LLC1488f5ae-3b34-fcd7-6049-215929b1d3242024-06-24Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
EnilloRingETONOGESTREL AND ETHINYL ESTRADIOL VAGINALXiromed, LLC85a126f6-d3e0-9e12-73f9-6176ba36f58b2024-06-24Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
My WayLEVONORGESTRELNuCare Pharmaceuticals,Inc.6598a875-8be8-0928-e053-2a91aa0a064d2024-06-06WarningsExact identifier
unii: 5W7SIA7YZW
NUVARINGETONOGESTREL AND ETHINYL ESTRADIOLA-S Medication Solutionse14bc197-dd22-4e6e-8aa1-d6cf2242fe0f2024-03-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
JinteliNORETHINDRONE ACETATE AND ETHINYL ESTRADIOLTeva Pharmaceuticals USA, Inc.d667ca75-1a17-43fc-9077-f25ce0908f8d2024-02-27Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
XULANENORELGESTROMIN AND ETHINYL ESTRADIOLA-S Medication Solutionsadcf17ef-e60b-48a4-9478-3998dab2bbbd2024-02-27Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOLNORETHINDRONE ACETATE AND ETHINYL ESTRADIOLMylan Pharmaceuticals Inc.3108a9bc-3378-459d-8f6b-bd5eff2ad6572024-01-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOLNORETHINDRONE ACETATE AND ETHINYL ESTRADIOLMylan Pharmaceuticals Inc.89948751-bd6e-4e9c-b87c-8782706c10972024-01-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
ZAFEMYNORELGESTROMIN AND ETHINYL ESTRADIOLBryant Ranch Prepack77230a20-4269-4abf-ae2a-ac5ccafef5652024-01-05Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
Etonogestrel/Ethinyl EstradiolETONOGESTREL AND ETHINYL ESTRADIOLA-S Medication Solutionsfcf9da2a-bb91-4697-bfaa-c9d58855e2752023-11-22Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
Aurovela 1.5/30NORETHINDRONE ACETATE AND ETHINYL ESTRADIOLAurobindo Pharma Limitedb146e49c-a0fc-4f3d-9ad6-99e8257fa1392023-11-21Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
PostDay One-StepLEVONORGESTRELRapha Pharmaceuticals, Inc.6f7f5697-acb6-ea95-e053-2991aa0ae7c72023-11-21WarningsExact identifier
unii: 5W7SIA7YZW
Aurovela 1/20NORETHINDRONE ACETATE AND ETHINYL ESTRADIOLAurobindo Pharma Limited6765becf-7b51-4f33-ac13-70fcd01decf72023-11-21Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
Plan B One-StepLEVONORGESTRELA-S Medication Solutionsfcc7ba8e-ad54-4efe-87e4-5eb0fbf4f0642023-10-24WarningsExact identifier
unii: 5W7SIA7YZW
LevonorgestrelLEVONORGESTRELXiromed LLC626a2333-ff56-ef28-a287-b33bacc0302a2023-09-05WarningsExact identifier
unii: 5W7SIA7YZW
Anubis BarcelonaGLYCERIN, SORBITOL, ALOE BARBADENSIS LEAF JUICEANUBIS COSMETICS SLeb651769-4d98-2b3b-e053-2a95a90a36b02023-09-01WarningsExact identifier
unii: H3R47K3TBD
Anubis Barcelona Total HydratingBETAINE, GLYCERIN, POLYSORBATE 20ANUBIS COSMETICS SLeaefe3b9-9064-18b1-e053-2a95a90a57652023-09-01WarningsExact identifier
unii: H3R47K3TBD
Anubis Barcelona New EvenLACTIC ACID, CITRIC ACID, GLYCOLIC ACIDANUBIS COSMETICS SLeaeeb6e0-5322-20c4-e053-2995a90a9fd92023-09-01WarningsExact identifier
unii: H3R47K3TBD
LILETTALEVONORGESTRELAllergan, Inc.aaf0eb2a-f88a-4f26-a445-0fd30176c3262023-06-29Warnings, Adverse reactionsExact identifier
unii: 5W7SIA7YZW

Reported adverse events (FAERS/openFDA)#

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