FDA.reportPublic FDA data

NDC 63629-2350-01 - Tri-Estarylla

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
63629-2350
Requested NDC
63629-2350-01
Package NDCs from labels
63629-2350-1, 63629-2350-01
Manufacturer
Bryant Ranch Prepack
Effective date
2024-05-21
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Tri-Estarylla - Bryant Ranch PrepackBryant Ranch Prepack2024-05-21HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63629-2350-1Tri-Estarylla3 in 1 CARTONKIT3104
63629-2350-1Tri-Estarylla1 in 1 BLISTER PACKKIT1104

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-2350TRI-ESTARYLLA (NORGESTIMATE AND ETHINYL ESTRADIOL) KIT [BRYANT RANCH PREPACK]104Current NDC, Legacy NDC, 2 package rows20240523_6560d15f-6ce9-4f0e-9b59-043dec35ddd9.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-2350-1EA - Each63629-23508dc96fcc-3ee9-4672-aceb-0ecdfd47f4ec12021-07-15

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 11 · 217 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Etonogestrel and Ethinyl Estradiol VaginalETONOGESTREL AND ETHINYL ESTRADIOL VAGINALAvKARE05e172aa-e18a-427b-e063-6294a90ae22f2026-09-09Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
SprintecNORGESTIMATE AND ETHINYL ESTRADIOLPreferred Pharmaceuticals, Inc.90240210-0bca-4a55-99dc-19f2b40d8e3f2026-08-31Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
rxcui: 240128
SLYNDDROSPIRENONEExeltis USA, Inc.db32bc55-f295-4d87-9dbb-0a2f45573dcf2026-08-27Warnings, Adverse reactionsExact identifier
rxcui: 748797
IsibloomDESOGESTREL AND ETHINYL ESTRADIOLBryant Ranch Prepack4a8f278f-f505-4537-8deb-74e8927df8c62026-08-12Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
EstaryllaNORGESTIMATE AND ETHINYL ESTRADIOLBryant Ranch Prepacke0b07fb6-8dbd-4e5d-b589-5191a1dc02ae2026-08-12Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
rxcui: 240128
DROSPIRENONE AND ETHINYL ESTRADIOLDROSPIRENONE AND ETHINYL ESTRADIOLRedpharm Drug57d1d945-9fc9-4e79-e063-6294a90a738a2026-07-30Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
norgestimate and ethinyl estradiolNORGESTIMATE AND ETHINYL ESTRADIOLPD-Rx Pharmaceuticals, Inc.2385591b-70ee-0577-e063-6394a90a93572026-07-29Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
TwirlaLEVONORGESTREL/ETHINYL ESTRADIOLAgile Therapeutics, Inc.bcaf8db0-1750-425d-b008-255b5e7a9cc62026-06-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
Desogestrel and Ethinyl EstradiolDESOGESTREL AND ETHINYL ESTRADIOLCamber Pharmaceuticals, Inc.78454ebf-f1a3-4ca0-b32e-88c51bc577732026-06-24Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
VIORELEDESOGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOLA-S Medication Solutions6422dcc3-959a-4590-9ca8-9dcb58e682532026-06-23Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
MONO-LINYAHNORGESTIMATE AND ETHINYL ESTRADIOLA-S Medication Solutions2ec8f18f-297c-405f-b191-a40767366bad2026-06-23Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
rxcui: 240128
TurqozNORGESTREL AND ETHINYL ESTRADIOLA-S Medication Solutionse7a05138-91a5-4c66-a915-614576e0805a2026-05-21Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
KurveloLEVONORGESTREL AND ETHINYL ESTRADIOLLupin Pharmaceuticals, Inc.752f525e-1838-4058-9ab7-2c2d91f86dfd2026-05-20Boxed warning, WarningsExact identifier
rxcui: 748797
DROSPIRENONE AND ETHINYL ESTRADIOLDROSPIRENONE AND ETHINYL ESTRADIOLApotex Corp.9187a357-e95d-4733-9627-f19522b863732026-05-14Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
Caldesene BabySTARCH, CORN AND ZINC OXIDEInsight Pharmaceuticals LLC9f12dee2-7afa-45e9-a729-0fd42bb777152026-04-22WarningsExact identifier
unii: O8232NY3SJ
Caldesene Medicated ProtectingCORNSTARCH AND ZINC OXIDEInsight Pharmaceuticals LLCffc92a0f-a7cf-4a46-b2f1-089df2bbb96b2026-04-22WarningsExact identifier
unii: O8232NY3SJ
norelgestromin and ethinyl estradiolNORELGESTROMIN AND ETHINYL ESTRADIOLZydus Pharmaceuticals USA Inc.10fa1458-c8ed-4197-922a-1ba7271d2b022026-04-16Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
norelgestromin and ethinyl estradiolNORELGESTROMIN AND ETHINYL ESTRADIOLZydus Lifesciences Limited7c2cc8ab-db6d-4a1c-ae74-e0ef27e2f3a92026-04-16Exact identifier
unii: 423D2T571U
WeraNORETHINDRONE AND ETHINYL ESTRADIOLNorthstar Rx LLC638e4f36-1a27-4220-8ec9-3fa9d9b36c112026-04-15Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
Dasetta 7/7/7NORETHINDRONE AND ETHINYL ESTRADIOLNorthstar Rx LLCda52e74a-1baf-4a33-a068-b491767003202026-04-14Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797

Reported adverse events (FAERS/openFDA)#

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