FDA.reportPublic FDA data

NDC 70700-303-84 - ABIGALE

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
70700-303
Requested NDC
70700-303-84
Package NDCs from labels
70700-303-84, 70700-303-85
Manufacturer
Xiromed LLC
Effective date
2024-09-17
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
ABIGALE - Xiromed LLCXiromed LLC2024-09-17HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70700-303-84ABIGALE LO28 in 1 BLISTER PACKTABLET281
70700-303-84ABIGALE LO1 in 1 POUCHTABLET11
70700-303-85ABIGALE LO3 in 1 CARTONTABLET31

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70700-303ABIGALE (ESTRADIOL AND NORETHINDRONE ACETATE) TABLET ABIGALE LO (ESTRADIOL AND NORETHINDRONE ACETATE) TABLET [XIROMED LLC]1Current NDC, 3 package rows20250306_df013d36-de10-0607-7e12-95ed43bf7ee9.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70700-303-84EA - Each70700-30372f95779-8263-4f0a-ad50-5aacddcedb9212025-07-08
70700-303-85EA - Each70700-3031779329e-c90a-4deb-9c20-35d128b79f2312025-07-08

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 1 of 10 · 199 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Estriora CreamESTRIOL AND ESTRADIOL CREAMGuangzhou Shunfei Network Technology Co., Ltd.5a53c026-aa7c-6c09-e063-6394a90a36e12026-08-31WarningsExact identifier
unii: 4TI98Z838E
EstradiolESTRADIOLA-S Medication Solutionsc8a2d29c-299c-4559-b859-87b303a4af812026-08-28Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
GynobalanceDEHYDROEPIANDROSTERONE, ESTRADIOL, PREGNENOLONE, PROGESTERONE, TESTOSTERONEBioActive Nutritional, Inc.61fa6e6e-42f5-4992-87b5-0770218abc8c2026-08-24WarningsExact identifier
unii: 4TI98Z838E
EstradiolESTRADIOLTrigen Laboratories, LLCe84ad638-6768-41aa-b2b8-e2514ef638812026-08-21Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
MinivelleESTRADIOLNoven Therapeutics, LLC6c5c47ab-28ee-11e1-bfc2-0800200c9a662026-07-31Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
EstradiolESTRADIOLRedpharm Drug5718f042-e8c0-b721-e063-6294a90a5bef2026-07-21Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
ESTRADIOLESTRADIOLA-S Medication Solutions5c9a2e0f-704b-4d16-8ea3-d94f7f36ce6b2026-07-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
Estradiol / Norethindrone AcetateESTRADIOL AND NORETHINDRONE ACETATEA-S Medication Solutionse166bdf6-eb60-49b8-9747-2a33c3e3461b2026-06-26Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1359127
rxcui: 1359126
unii: 4TI98Z838E
unii: 9S44LIC7OJ
Estradiol and Norethindrone AcetateESTRADIOL AND NORETHINDRONE ACETATEA-S Medication Solutions1521007a-546d-421e-99e1-e10d90c0b0902026-06-26Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1359124
rxcui: 1359123
unii: 4TI98Z838E
unii: 9S44LIC7OJ
EstradiolESTRADIOLANI Pharmaceuticals, Inc.ff28c624-906d-459c-8b8c-27cb1a664e122026-06-23Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
Estradiol VaginalESTRADIOLRedpharm Drug546c168d-2a85-69b6-e063-6294a90a22ac2026-06-17Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
ESTRADIOLESTRADIOLBryant Ranch Prepacke6bf2abc-71ae-4e79-a37b-164c98ba746a2026-06-16Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
EstradiolESTRADIOLA-S Medication Solutions34bcec8e-c7a6-4a1c-9884-4d4efe024bb92026-06-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
EstradiolESTRADIOLREMEDYREPACK INC.41f7a56c-4ce3-4cc6-803e-1ff662efef902026-06-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
EstradiolESTRADIOLREMEDYREPACK INC.59a4b68d-a507-4809-a0c8-fd9799986d122026-06-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
EstradiolESTRADIOLA-S Medication Solutionsba935918-39b3-4b56-bd83-78a29958e6d82026-06-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
EstradiolESTRADIOLA-S Medication Solutions1c38f0d0-a360-4b66-bc0e-7d54e92465a12026-06-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
ESTRADIOLESTRADIOLREMEDYREPACK INC.477cb52e-8ce2-491f-94a0-869ff60bf7ab2026-06-08Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
EstradiolESTRADIOLA-S Medication Solutionseacafc4a-2fa8-403d-8df7-2bc92d73a54f2026-06-03Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
EstradiolESTRADIOLA-S Medication Solutionsee5460ab-27e7-487a-a89c-bf8735399be62026-06-03Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E

Reported adverse events (FAERS/openFDA)#

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