FDA.reportPublic FDA data

NDC 50102-120-01 - AUBRA

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
50102-120
Requested NDC
50102-120-01
Package NDCs from labels
50102-120-00, 50102-120-01, 50102-120-48, 50102-120-10, 50102-120-03
Manufacturer
Afaxys Pharma, LLC | Mylan Laboratories Limited
Effective date
2021-01-25
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
AUBRA - Afaxys Pharma, LLC | Mylan Laboratories LimitedAfaxys Pharma, LLC | Mylan Laboratories Limited2021-01-25HUMAN PRESCRIPTION DRUG LABEL
Aubra® (Levonorgestrel and Ethinyl Estradiol Tablets, USP 0.1 mg/0.02 mg)RPK Pharmaceuticals, Inc.2020-12-15HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
50102-120-032023-02-17Aubra® (Levonorgestrel and Ethinyl Estradiol Tablets, USP 0.1 mg/0.02 mg)
50102-120-482023-02-17Aubra® (Levonorgestrel and Ethinyl Estradiol Tablets, USP 0.1 mg/0.02 mg)
50102-120-032023-01-30Aubra® (Levonorgestrel and Ethinyl Estradiol Tablets, USP 0.1 mg/0.02 mg)
50102-120-482023-01-30Aubra® (Levonorgestrel and Ethinyl Estradiol Tablets, USP 0.1 mg/0.02 mg)

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50102-120-00EA - Each50102-120d9bee6d9-aa9d-4898-93de-438dae2bb86912022-06-06
50102-120-01EA - Each50102-1208b796782-496f-4ed0-b025-66127b0fc3f912013-11-04
50102-120-03EA - Each50102-120c2265cdf-ed8f-437d-9e4b-312af0119f7112017-09-11
50102-120-10EA - Each50102-1205c1fb698-e254-4b92-8ed9-eb87d360463212017-09-11
50102-120-48EA - Each50102-1208a66d499-33ea-4443-a859-d114a324025512013-11-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ETHINYL ESTRADIOLACTIVE INGREDIENT423D2T571UAUBRA (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [AFAXYS INC.]4
LEVONORGESTRELACTIVE INGREDIENT5W7SIA7YZWAUBRA (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [AFAXYS INC.]4
ETHINYL ESTRADIOLACTIVE MOIETY423D2T571UAUBRA (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [AFAXYS INC.]4
LEVONORGESTRELACTIVE MOIETY5W7SIA7YZWAUBRA (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [AFAXYS INC.]4
BROWN IRON OXIDEINACTIVE INGREDIENT1N032N7MFOAUBRA (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [AFAXYS INC.]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UAUBRA (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [AFAXYS INC.]4
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48AUBRA (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [AFAXYS INC.]4
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675AUBRA (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [AFAXYS INC.]4
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTAUBRA (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [AFAXYS INC.]4
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XAUBRA (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [AFAXYS INC.]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30AUBRA (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [AFAXYS INC.]4
POVIDONE K25INACTIVE INGREDIENTK0KQV10C35AUBRA (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [AFAXYS INC.]4
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JAUBRA (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [AFAXYS INC.]4

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 9 of 9 · 171 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
0e39696d-cd9b-4df1-a1c4-a5f24df306f07cff92f9-eaec-4982-8f25-2e1596fb2fb22020-12-22Boxed warning, Warnings, Adverse reactionsExact identifier
spl set id: 7cff92f9-eaec-4982-8f25-2e1596fb2fb2
Option 2LEVONORGESTRELL. Perrigo Company9b9e9352-3e4d-4ec3-96aa-8fd58d82fe962020-07-30WarningsExact identifier
unii: 5W7SIA7YZW
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.