FDA.reportPublic FDA data

NDC 65862-849-28 - Afirmelle

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
65862-849
Requested NDC
65862-849-28
Package NDCs from labels
65862-849-28, 65862-849-88, 65862-849-92
Manufacturer
Aurobindo Pharma Limited
Effective date
2025-08-01
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Afirmelle - Aurobindo Pharma LimitedAurobindo Pharma Limited2025-08-01Human Prescription Drug Label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65862-849-28Afirmelle1 in 1 POUCHKIT110
65862-849-28Afirmelle1 in 1 BLISTER PACKKIT110
65862-849-88Afirmelle3 in 1 CARTONKIT310
65862-849-92Afirmelle6 in 1 CARTONKIT610
65862-849-92Afirmelle1 in 1 POUCHKIT110

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65862-849AFIRMELLE (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [AUROBINDO PHARMA LIMITED]9Current NDC, Legacy NDC, 5 package rows20240927_dd6122cd-b7ba-4fe3-bde5-910882475b67.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65862-849-28EA - Each65862-84910c7e1b8-a3f8-44e3-952d-cd9c9f0e2c1d12019-07-02
65862-849-88EA - Each65862-84927c3310e-9ffa-4062-bb70-d16486d9288312019-07-02

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 8 of 15 · 281 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Junel 21 DayNORETHINDRONE ACETATE AND ETHINYL ESTRADIOLProficient Rx LP56e91ad4-f31b-494d-9e75-6dd4f396779c2024-12-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
VienvaLEVONORGESTREL AND ETHINYL ESTRADIOLXiromed, LLC.58ea31df-f9cf-7d00-c2db-0529fb9a3e532024-11-11Warnings, Adverse reactionsExact identifier
rxcui: 748797
rxcui: 242297
rxcui: 748868
KalligaDESOGESTREL AND ETHINYL ESTRADIOLAurobindo Pharma Limiteddbe9f9ab-2e38-49e3-bb1f-c8a12d03076a2024-11-02Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
NYLIA 7/7/7NORETHINDRONE AND ETHINYL ESTRADIOLA-S Medication Solutions4ade84c1-e172-443f-aac7-0e8407aaa7de2024-10-25Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
JoyeauxLEVONORGESTREL AND ETHINYL ESTRADIOL AND FERROUS FUMARATEXiromed, LLC655b2c93-cfae-d44f-c128-c816bbd88e452024-10-18Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
rxcui: 242297
rxcui: 748868
INTROVALELEVONORGESTREL AND ETHINYL ESTRADIOL TABLETSXiromed LLC24abb5e1-5be4-87e7-404c-d8c2db25ffd02024-10-15Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
SIMLIYADESOGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOLAurobindo Pharma Limited4161f614-6e55-4114-87f7-19bb77f6b09b2024-10-09Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
EstaryllaNORGESTIMATE AND ETHINYL ESTRADIOLProficient Rx LP7acde5ef-f457-4c47-897b-d048194c7d7e2024-10-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
AvianeLEVONORGESTREL AND ETHINYL ESTRADIOLProficient Rx LP411e6e51-b435-4f86-b39f-3377f009b0e92024-10-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
rxcui: 242297
rxcui: 748868
LOJAIMIESSLEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL TABLETSXiromed LLC2a20c571-59c7-cadf-dcf7-1b4707c661a32024-09-16Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 242297
LevonorgestrelLEVONORGESTRELOhm Laboratories Inc.5c509934-8c11-4d7f-8506-5971c37cfc222024-09-06WarningsExact identifier
unii: 5W7SIA7YZW
AvianeLEVONORGESTREL AND ETHINYL ESTRADIOLTeva Pharmaceuticals USA, Inc.8f88b17a-5d0e-448a-8a60-f49c28ba6dfb2024-07-29Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
rxcui: 242297
rxcui: 748868
IcleviaLEVONORGESTREL AND ETHINYL ESTRADIOLAurobindo Pharma Limited00657f4e-9df8-4f58-91a0-eff5a467f9882024-07-02Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
NataziaESTRADIOL VALERATE AND ESTRADIOL VALERATE/DIENOGESTBayer HealthCare Pharmaceuticals Inc.02c91fba-9c47-43ef-ac78-e823697988342024-06-26Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
AzuretteDESOGESTREL/ETHINYL ESTRADIOL AND ETHINYL ESTRADIOLDr. Reddys Laboratories Inc.f0288c8d-6ca0-41fa-93f2-b6c2d073891f2024-06-25Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
Etonogestrel and Ethinyl Estradiol Vaginal RingETONOGESTREL AND ETHINYL ESTRADIOL VAGINAL RINGNorthstar Rx LLC1488f5ae-3b34-fcd7-6049-215929b1d3242024-06-24Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
EnilloRingETONOGESTREL AND ETHINYL ESTRADIOL VAGINALXiromed, LLC85a126f6-d3e0-9e12-73f9-6176ba36f58b2024-06-24Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
Apri 28 DayDESOGESTREL AND ETHINYL ESTRADIOLA-S Medication Solutions3448d121-d00a-4752-8782-416b7a376f3f2024-06-12Warnings, Adverse reactionsExact identifier
rxcui: 748797
My WayLEVONORGESTRELNuCare Pharmaceuticals,Inc.6598a875-8be8-0928-e053-2a91aa0a064d2024-06-06WarningsExact identifier
unii: 5W7SIA7YZW
Zovia 1/35ETHYNODIOL DIACETATE AND ETHINYL ESTRADIOL TABLETSDr. Reddys Laboratories Inc.fb636d42-cc1d-47f7-974d-c97c79207f3e2024-06-01Warnings, Adverse reactionsExact identifier
rxcui: 748797

Reported adverse events (FAERS/openFDA)#

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