FDA.reportPublic FDA data

NDC 42291-962-11 - Yuvafem

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
42291-962
Requested NDC
42291-962-11
Package NDCs from labels
42291-962-11, 42291-962-08, 42291-962-18
Manufacturer
AvKARE
Effective date
2026-01-19
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Yuvafem - AvKAREAvKARE2026-01-19HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42291-962-08Yuvafem8 in 1 CARTONTABLET89
42291-962-11Yuvafem1 in 1 APPLICATORTABLET19
42291-962-18Yuvafem18 in 1 CARTONTABLET189

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42291-962YUVAFEM (ESTRADIOL) TABLET [AVKARE]8Current NDC, Legacy NDC, 3 package rows20240111_d20abc9a-8f47-e274-c9b1-b71c9489761f.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42291-962-08EA - Each42291-9621e865e1b-5df2-422c-bcdf-4889a01d7a0012016-12-07
42291-962-11EA - Each42291-962b6e839c4-ff41-493e-b670-a91f756e23f612025-05-14
42291-962-18EA - Each42291-962cd5dff2b-a8de-4bdb-8f73-395b7066d49512016-12-07

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 11 · 206 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LensMate Preservative-Free Artificial TearsLUBRICANT EYE DROPSYD BIO USA, INC.4ebacb2b-9b2d-6bc1-e063-6294a90a34262026-04-05WarningsExact identifier
unii: 3NXW29V3WO
Exovisse Preservative-Free Artificial TearsLUBRICANT EYE GEL DROPSYD BIO USA, INC.4ebc154b-128b-9dde-e063-6294a90ae00e2026-04-05WarningsExact identifier
unii: 3NXW29V3WO
Estradiol VaginalESTRADIOLBryant Ranch Prepack67f581cb-6d77-49fc-b2f3-976e3b57dcbf2026-03-31Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
Crocodile Tears Lubricant Eye DropsGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400Crocodile Tears LLC4df29336-ea0c-0484-e063-6294a90a685a2026-03-26WarningsExact identifier
unii: 3NXW29V3WO
Climara ProESTRADIOL AND LEVONORGESTRELBayer HealthCare Pharmaceuticals Inc.184d3092-7fc6-4375-816b-1ab06bb99cfd2026-03-26Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
ClimaraESTRADIOLBayer HealthCare Pharmaceuticals Inc.1e9702c4-f2d7-4ea8-b6e8-7dca316718642026-03-26Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
Artificial Tears Lubricant Eye DropsGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400KC Pharmaceuticals, Inc4de5c844-85ca-ff9f-e063-6394a90ac12c2026-03-25WarningsExact identifier
unii: 3NXW29V3WO
MenostarESTRADIOLBayer HealthCare Pharmaceuticals Inc.a78708cd-04d4-4221-a4e4-53680bbe29122026-03-12Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
Artificial TearsGLYCERINPreferred Pharmaceuticals Inc.dd646c72-8f47-43c6-a734-db0dcc8cd4d12026-03-06WarningsExact identifier
unii: 3NXW29V3WO
Estradiol Transdermal SystemESTRADIOLSandoz Incc714974b-766f-42f2-a846-b0c1f5a605602026-03-04Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
AngeliqDROSPIRENONE AND ESTRADIOLBayer HealthCare Pharmaceuticals Inc.761834c2-6b61-4583-84c2-f1ca4a97c4f22026-03-02Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
ESTRADIOLESTRADIOLPadagis Israel Pharmaceuticals Ltd3ac905b3-904c-4285-97ed-e787d006c7dd2026-02-28Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
DIVIGELESTRADIOLVertical Pharmaceuticals, LLC59e610dc-883e-4f07-9ec6-a5841b0bf9fb2026-02-27Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
Female StimulantACONITICUM ACIDUM, CIS-, APIS VENENUM PURUM, AQUILEGIA VULGARIS, BOVISTA, CYPRIPEDIUM PUBESCENS, ESTRADIOL, FAECALIS (ALKALIGENES), FOLLICULINUM, FUNICULUS UMBILICALIS SUIS, GLANDULA SUPRARENALIS SUIS, HEART (SUIS), HYDRASTIS CANADENSIS, HYPOPHYSIS SUIS, KREOSOTUM, LACHESIS MUTUS, LILIUM TIGRINUM, MAGNESIA PHOSPHORICA, MERCURIUS SOLUBILIS, MUTABILE BACILLUS (BACH), OOPHORINUM (SUIS), PETROSELINUM SATIVUM, PINEAL GLAND (SUIS), PLACENTA TOTALIS SUIS, PROGESTERONE, SEPIA, TESTOSTERONE, UTERUS (SUIS)Deseret Biologicals, Inc.0d4b8cbf-8f57-43ca-a904-c69d9056c8652026-02-19WarningsExact identifier
unii: 4TI98Z838E
EstradiolESTRADIOL TRANSDERMALAmneal Pharmaceuticals NY LLC9669a0e3-27e2-4f6c-961c-7a67e9f84cc82026-02-19Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
EstradiolESTRADIOLMylan Pharmaceuticals Inc.98770987-b313-4f2a-9aac-db0ab2068cc62026-02-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
EstradiolESTRADIOLSolaris Pharma Corporation67e8665c-5331-423c-99fd-546ab6cccb072026-01-26Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
YuvafemESTRADIOLAvKAREd20abc9a-8f47-e274-c9b1-b71c9489761f2026-01-19Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA205256
ndc (package): 42291-962-08
ndc (package): 42291-962-18
ndc (package): 42291-962-11
ndc (product): 42291-962
ndc11 (package): 42291096211
rxcui: 1797113
rxcui: 884707
spl id: 48c2d001-2094-12ab-e063-6294a90a4f10
spl set id: d20abc9a-8f47-e274-c9b1-b71c9489761f
unii: 4TI98Z838E
Lotrimin Daily Sweat and Odor ControlTOPICAL STARCHBayer HealthCare LLC.9ec5c80d-b550-496f-e053-2a95a90a54892026-01-16WarningsExact identifier
unii: O8232NY3SJ
Estradiol VaginalESTRADIOLAvKAREbb7b442d-b8c3-b7f0-e053-2a95a90a2c942026-01-14Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E

Reported adverse events (FAERS/openFDA)#

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