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 3 of 9 · 171 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CalamineCALAMINE, PRAMOXIND HCLPerrigo Direct, Inc54a20ec9-ab86-4410-af94-e04393e9d4b32026-02-19Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
CalamineCALAMINE, PRAMOXINE HCLMeijer, Inc.6b369ef2-fd54-4931-a9eb-0fb42834c2ef2026-02-19Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
CalamineFERRIC OXIDE REDTarget Corporationd4ee05c8-ae62-45df-8783-1ed57fa030ec2026-02-18Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
CalamineFERRIC OXIDE REDTopco Associates LLC2b32e720-ac71-4d60-bc06-e28a00f8a4502026-02-13Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
CalamineCALAMINE, PRAMOXINE HCLTopco Associates LLC15d1ae3f-509c-4e6b-8f0c-cf92656803582026-02-13Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
CalamineFERRIC OXIDE REDMajor Pharmaceuticalsc25be68d-834a-4959-8d47-01ec789406ba2026-02-04Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
LevonorgestrelLEVONORGESTRELYYBA Corp49008f10-8a70-3c08-e063-6294a90a44a32026-02-03WarningsExact identifier
unii: 5W7SIA7YZW
Aquavit 1AQUAVIT 1Uriel Pharmacy Inc.2354fcfc-05a2-444a-ace4-b3df614131572026-02-02WarningsExact identifier
unii: 1K09F3G675
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
Norethindrone Acetate and Ethinyl EstradiolNORETHINDRONE ACETATE AND ETHINYL ESTRADIOLGlenmark Pharmaceuticals Inc., USA5a44f7a2-45f1-4d28-b9fb-61d9f24564222026-01-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
Hailey 1.5/30NORETHINDRONE ACETATE AND ETHINYL ESTRADIOLGlenmark Pharmaceuticals Inc., USA021df70a-0c37-4237-a2f7-2597ff6d41f52026-01-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
CalamineCALAMINEAMERISOURCE BERGEN90d9d908-57ea-4062-ade0-8a4888939c912026-01-29Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
Norethindrone Acetate and Ethinyl EstradiolNORETHINDRONE ACETATE AND ETHINYL ESTRADIOLGlenmark Pharmaceuticals Inc., USAcf549b5a-2707-4020-9f94-dab1260e16642026-01-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
ZAFEMYNORELGESTROMIN AND ETHINYL ESTRADIOLAvKAREfbbd12dd-c538-2869-e053-6294a90a1a382026-01-19Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
First Chakra (Root) 7301FIRST CHAKRA (ROOT)Professional Complementary Health Formulas61eb1bbe-6675-4369-b852-18975e6b08c72026-01-08WarningsExact identifier
unii: 1K09F3G675
Third Chakra (Solar Plexus) 7303THIRD CHAKRA (SOLAR PLEXUS)Professional Complementary Health Formulaseea89c37-ab87-4cc7-8dfc-e7f42a580dd92026-01-08WarningsExact identifier
unii: 1K09F3G675
FyavolvNORETHINDRONE ACETATE AND ETHINYL ESTRADIOLLupin Pharmaceuticals, Inc.772c86d7-10a4-48c5-8c19-f8aac68f5ab42026-01-06Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
DermagesicPRAMOXINE HCL, ZINC OXIDE, CALAMINELlorens Pharmaceutical International Divisionbbff6b53-29da-45c1-8ccd-3e9df7f250e02025-12-31WarningsExact identifier
unii: 1K09F3G675
BABY ANTI MONKEY BUTT DIAPER RASHZINC OXIDE, CALAMINEClarion Brands, LLCe4424d74-f89c-5943-42e8-bf3a38e686192025-12-23WarningsExact identifier
unii: 1K09F3G675
Her StyleLEVONORGESTRELIngenus Pharmaceuticals, LLC6e631755-b7c5-4a3a-b46d-f66b4ceedb1c2025-12-05WarningsExact identifier
unii: 5W7SIA7YZW

Reported adverse events (FAERS/openFDA)#

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