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 6 of 9 · 171 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Athentia NextLEVONORGESTRELAurohealth LLC34e5aa53-3943-4e2f-93aa-b5a4d779a7032025-04-04WarningsExact identifier
unii: 5W7SIA7YZW
After BangerLEVONORGESTRELAurohealth LLC791a2461-971c-4191-8905-5a449c600a492025-04-04WarningsExact identifier
unii: 5W7SIA7YZW
DolishaleLEVONORGESTREL AND ETHINYL ESTRADIOLIngenus Pharmaceuticals, LLC036a15be-8c2e-4f65-b5dc-f333e2994d4a2025-04-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
unii: 5W7SIA7YZW
NuvaRingETONOGESTREL AND ETHINYL ESTRADIOLAdvanz Pharma (US) Corp.19ef66d1-913f-49a8-a0a5-59b4e20322f52025-03-21Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
RID Poison Ivy Rash ReliefCALAMINE AND ZINC OXIDEOystershell Consumer Health Inc.36c3af9a-2646-4427-e063-6394a90a2c5e2025-03-13WarningsExact identifier
unii: 1K09F3G675
YVTYVT MICRODERMABRASION FACIAL SCRUBYVTYVT MICRODERMABRASION FACIAL SCRUBBeijing JUNGE Technology Co., Ltd.2f30fc45-42e2-c766-e063-6394a90a8d682025-02-28WarningsExact identifier
unii: OP1R32D61U
Junel 21 DayNORETHINDRONE ACETATE AND ETHINYL ESTRADIOLTeva Pharmaceuticals USA, Inc.8b82ad14-580c-4145-b825-dce849f953632025-02-27Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
Etonogestrel/Ethinyl EstradiolETONOGESTREL AND ETHINYL ESTRADIOLPrasco Laboratoriesf0d80e01-f4f5-4b1a-bc9e-50a2bd4390b12025-02-26Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
Loestrin Fe 28 DayNORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATETeva Women's Health LLCf29ebcb5-7e65-4092-bfaa-f5ec026fc2552025-02-20Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
Morning After PillLEVONORGESTRELCadence Health Incfc5d29bb-4a4b-e61e-e053-6394a90a8a622025-02-14WarningsExact identifier
unii: 5W7SIA7YZW
CalamineFERRIC OXIDE REDPreferred Pharmaceuticals Inc.326f3d80-c1bf-4cf0-a662-58e02ed7ee672025-02-12Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
LUIZZA 1.5/30NORETHINDRONE ACETATE AND ETHINYL ESTRADIOLXiromed LLCb1c3e33d-ec95-cd89-7ad9-36994c802a1f2025-02-12Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
Prunus IronPRUNUS IRONUriel Pharmacy Inc.091be588-b62e-4919-8e9e-3edb9792d3192025-01-22WarningsExact identifier
unii: 1K09F3G675
EluRyngETONOGESTREL AND ETHINYL ESTRADIOLAmneal Pharmaceuticals LLCc6c8512d-b258-4be5-8c2f-0f1893f198b92025-01-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
Ferrum Silicicum UrticaFERRUM SILICICUM URTICAUriel Pharmacy Inc.09829ac4-c074-7315-e063-6394a90adf592025-01-07WarningsExact identifier
unii: 1K09F3G675
My WayLEVONORGESTRELProficient Rx LPf2354b0c-dda4-4eb4-93f3-b2d57856a9482025-01-01WarningsExact identifier
unii: 5W7SIA7YZW
LevonorgestrelLEVONORGESTRELThirty Madison Inc.6933ae19-4c8f-49a2-96c5-9cdf37ee58242024-12-30WarningsExact identifier
unii: 5W7SIA7YZW
Household AntigensACETONE, SODIUM TRIPOLYPHOSPHATE, PROPYLENE GLYCOL, BENZINUM, AMMONIUM MURIATICUM, SODIUM LAURYL SULFATE, TEREBINTHINA, BUTYL ACETATE, ETHYL ACETATE, TOLUENE, XYLENE, BISPHENOL A, PETROLEUM, FORMALINUM, GLYPHOSATE, METHYLPARABEN, NAPHTHALINUM, PROPYLPARABEN, ANACARDIUM ORIENTALE, GRAPHITES, NITRICUM ACIDUM, PULSATILLA (PRATENSIS), SULPHUR, PARAFFINUMEnergique, Inc.f3db63df-62a4-48d6-92e7-94e4a57015522024-12-20WarningsExact identifier
unii: 368GB5141J
Junel 21 DayNORETHINDRONE ACETATE AND ETHINYL ESTRADIOLProficient Rx LP56e91ad4-f31b-494d-9e75-6dd4f396779c2024-12-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
CaladrylFERRIC OXIDE RED, ZINC OXIDE, AND PRAMOXINE HYDROCHLORIDEBausch Health US, LLC67d4fd42-9fed-4238-9f5a-c9403abbcf202024-10-17WarningsExact identifier
unii: 1K09F3G675

Reported adverse events (FAERS/openFDA)#

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