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 5 of 6 · 104 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LevonorgestrelLEVONORGESTRELNaari Pte Limitedbe8b7ace-9af8-4417-85fa-863e190728872023-03-16WarningsExact identifier
unii: 5W7SIA7YZW
50084570-5af8-48b3-9b85-2224302925988020e9b2-59c0-4417-b0e9-f1a152e919fd2023-02-23Boxed warning, Warnings, Adverse reactionsExact identifier
spl set id: 8020e9b2-59c0-4417-b0e9-f1a152e919fd
Next Choice One DoseLEVONORGESTRELFoundation Consumer Healthcare LLC504735bd-6af9-4588-bf85-d09dbf2a7e412023-02-02WarningsExact identifier
unii: 5W7SIA7YZW
Take ActionLEVONORGESTRELFoundation Consumer Healthcare LLC78eee7c9-5ca5-45af-898f-92a2f3b2598e2023-01-31WarningsExact identifier
unii: 5W7SIA7YZW
AfteraLEVONORGESTRELFoundation Consumer Healthcare LLC53ad8dff-9134-475c-90b3-8087753e17c42023-01-31WarningsExact identifier
unii: 5W7SIA7YZW
Plan B One-StepLEVONORGESTRELFoundation Consumer Healthcare LLC6ce6b40e-14ac-47bd-a648-ddf9e452e5592023-01-31WarningsExact identifier
unii: 5W7SIA7YZW
Opcicon One-StepLEVONORGESTRELSun Pharmaceutical Industries, Inc.b67ca313-561e-471f-baf3-257b7e253c752023-01-13WarningsExact identifier
unii: 5W7SIA7YZW
Morning AfterLEVONORGESTRELRapha Pharmaceuticals, Inc.f0fab784-3d28-35fb-e053-2995a90ab6112022-12-29WarningsExact identifier
unii: 5W7SIA7YZW
Etonogestrel and Ethinyl EstradiolETONOGESTREL AND ETHINYL ESTRADIOLTeva Pharmaceuticals USA, Inc.a8cc104a-d522-49ad-af54-2f312b829b612022-09-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
OptionelleLEVONORGESTREL TABLET, 1.5 MGStrides Pharma Inc1c7e849c-6392-48a6-9214-907325a012e22022-09-16WarningsExact identifier
unii: 5W7SIA7YZW
Levonorgestrel Tablet, 1.5 mgLEVONORGESTREL TABLET, 1.5 MGStrides Pharma Inc98f6367e-14d2-4c7a-9418-d996f0040d222022-09-13WarningsExact identifier
unii: 5W7SIA7YZW
My Choice TMLEVONORGESTRELProficient Rx LP165f7270-d050-4e97-b30f-107b96940d842022-09-01WarningsExact identifier
unii: 5W7SIA7YZW
ZAFEMYNORELGESTROMIN AND ETHINYL ESTRADIOLAmneal Pharmaceuticals LLC5ee34c07-65af-42b8-a98f-e299ff90a8a12022-04-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
My Choice TMLEVONORGESTRELSUN PHARMACEUTICAL INDUSTRIES, INC.66753300-fb61-4f09-af74-ee498b0bd5952022-04-21WarningsExact identifier
unii: 5W7SIA7YZW
Norelgestromin and Ethinly EstradiolNORELGESTROMIN AND ETHINLY ESTRADIOLAmneal Pharmaceuticals NY LLC36445b6a-e0f2-42f7-a8f3-5b80c90b87dd2022-03-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
XULANENORELGESTROMIN AND ETHINYL ESTRADIOLMylan Pharmaceuticals Inc.f7848550-086a-43d8-8ae5-047f4b9e43822022-03-04Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
AmethystLEVONORGESTREL AND ETHINYL ESTRADIOLTeva Pharmaceuticals, Inc.99073fe0-eac8-44dd-abe6-623fa67d9e792022-01-31Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
unii: 5W7SIA7YZW
Nortrel 28 DayNORETHINDRONE AND ETHINYL ESTRADIOLTeva Pharmaceuticals USA, Inc.140c50d6-c931-423a-9aa0-526eae7ab93c2021-12-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
e8d184ac-93be-421c-b52a-91fa41814aedb984de51-b5b6-4f45-a061-7264379985762020-12-22Boxed warning, Warnings, Adverse reactionsExact identifier
spl set id: b984de51-b5b6-4f45-a061-726437998576
Option 2LEVONORGESTRELL. Perrigo Company9b9e9352-3e4d-4ec3-96aa-8fd58d82fe962020-07-30WarningsExact identifier
unii: 5W7SIA7YZW

Reported adverse events (FAERS/openFDA)#

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