FDA.reportPublic FDA data

NDC 0430-0145-23 - femhrt

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
0430-0145
Requested NDC
0430-0145-23
Package NDCs from labels
0430-0145-14, 0430-0145-23
Manufacturer
Allergan, Inc.
Effective date
2017-11-01
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
femhrt - Allergan, Inc.Allergan, Inc.2017-11-01HUMAN PRESCRIPTION DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unitNational Council for Prescription Drug Programs2012-07-24Indexing - Billing Unit

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0430-0145-14EA - Each0430-014590eeeb02-42e2-4858-9747-933f6347bce212012-07-24
0430-0145-23EA - Each0430-0145a6085bdc-42ef-434e-b5ef-439ffa7a683912012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ETHINYL ESTRADIOLACTIVE INGREDIENT423D2T571UFEMHRT (NORETHINDRONE ACETATE/ETHINYL ESTRADIOL) TABLET [WARNER CHILCOTT (US), LLC]8
NORETHINDRONE ACETATEACTIVE INGREDIENT9S44LIC7OJFEMHRT (NORETHINDRONE ACETATE/ETHINYL ESTRADIOL) TABLET [WARNER CHILCOTT (US), LLC]8
ETHINYL ESTRADIOLACTIVE MOIETY423D2T571UFEMHRT (NORETHINDRONE ACETATE/ETHINYL ESTRADIOL) TABLET [WARNER CHILCOTT (US), LLC]8
NORETHINDRONEACTIVE MOIETYT18F433X4SFEMHRT (NORETHINDRONE ACETATE/ETHINYL ESTRADIOL) TABLET [WARNER CHILCOTT (US), LLC]8
CALCIUM STEARATEINACTIVE INGREDIENT776XM7047LFEMHRT (NORETHINDRONE ACETATE/ETHINYL ESTRADIOL) TABLET [WARNER CHILCOTT (US), LLC]8
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UFEMHRT (NORETHINDRONE ACETATE/ETHINYL ESTRADIOL) TABLET [WARNER CHILCOTT (US), LLC]8
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XFEMHRT (NORETHINDRONE ACETATE/ETHINYL ESTRADIOL) TABLET [WARNER CHILCOTT (US), LLC]8
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJFEMHRT (NORETHINDRONE ACETATE/ETHINYL ESTRADIOL) TABLET [WARNER CHILCOTT (US), LLC]8

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 4 · 68 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Norethindrone AcetateNORETHINDRONE ACETATETeva Pharmaceuticals USA, Inc.f73f9807-4af6-4faa-ba9a-656a47a4c5e02022-11-30Warnings, Adverse reactionsExact identifier
unii: 9S44LIC7OJ
Etonogestrel and Ethinyl EstradiolETONOGESTREL AND ETHINYL ESTRADIOLTeva Pharmaceuticals USA, Inc.a8cc104a-d522-49ad-af54-2f312b829b612022-09-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
ZAFEMYNORELGESTROMIN AND ETHINYL ESTRADIOLAmneal Pharmaceuticals LLC5ee34c07-65af-42b8-a98f-e299ff90a8a12022-04-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
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
Nortrel 28 DayNORETHINDRONE AND ETHINYL ESTRADIOLTeva Pharmaceuticals USA, Inc.140c50d6-c931-423a-9aa0-526eae7ab93c2021-12-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
LopreezaESTRADIOL/NORETHINDRONE ACETATEAmneal Pharmaceuticals NY LLCbf0e39cb-95e7-4831-92d2-0b3f071aeaae2017-11-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9S44LIC7OJ

Reported adverse events (FAERS/openFDA)#

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