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 3 of 15 · 281 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BRIELLYNNORETHINDRONE AND ETHINYL ESTRADIOLGlenmark Pharmaceuticals Inc., USAc0e2c5b4-70ac-4b41-aa71-00e506dbb72f2026-01-31Warnings, Adverse reactionsExact identifier
rxcui: 748797
VIORELEDESOGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOLGlenmark Pharmaceuticals Inc., USA39988aa6-8f68-40e8-9bdd-c40a3bdaad612026-01-31Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
ALYACEN 1/35NORETHINDRONE AND ETHINYL ESTRADIOLGlenmark Pharmaceuticals Inc., USA5c02b4d3-1e2f-439a-ae45-02304ee190d12026-01-31Warnings, Adverse reactionsExact identifier
rxcui: 748797
Levonorgestrel and Ethinyl EstradiolLEVONORGESTREL AND ETHINYL ESTRADIOLGlenmark Pharmaceuticals Inc., USA44fbc5ae-5682-471f-a12a-955e8b4d233a2026-01-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
unii: 5W7SIA7YZW
levonorgestrel and ethinyl estradiolLEVONORGESTREL AND ETHINYL ESTRADIOLGlenmark Pharmaceuticals Inc., USA3d87d9a4-860a-4ea7-a993-0f4adf1789da2026-01-30Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
Norethindrone Acetate and Ethinyl EstradiolNORETHINDRONE ACETATE AND ETHINYL ESTRADIOLGlenmark Pharmaceuticals Inc., USA5a44f7a2-45f1-4d28-b9fb-61d9f24564222026-01-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
Hailey 1.5/30NORETHINDRONE ACETATE AND ETHINYL ESTRADIOLGlenmark Pharmaceuticals Inc., USA021df70a-0c37-4237-a2f7-2597ff6d41f52026-01-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
drospirenone and ethinyl estradiolDROSPIRENONE AND ETHINYL ESTRADIOLGlenmark Pharmaceuticals Inc., USA0f8f8a21-cee8-462f-98b3-6c06f2f33e0d2026-01-29Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
Norethindrone Acetate and Ethinyl EstradiolNORETHINDRONE ACETATE AND ETHINYL ESTRADIOLGlenmark Pharmaceuticals Inc., USAcf549b5a-2707-4020-9f94-dab1260e16642026-01-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
MARLISSALEVONORGESTREL AND ETHINYL ESTRADIOLGlenmark Pharmaceuticals Inc., USA9379d99e-c416-4dab-a817-1c110e0d4b932026-01-29Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
Tri-EstaryllaNORGESTIMATE AND ETHINYL ESTRADIOLA-S Medication Solutionsf7f7c073-48e0-4065-970b-8103d76b6eb02026-01-27Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
ZAFEMYNORELGESTROMIN AND ETHINYL ESTRADIOLAvKAREfbbd12dd-c538-2869-e053-6294a90a1a382026-01-19Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
FyavolvNORETHINDRONE ACETATE AND ETHINYL ESTRADIOLLupin Pharmaceuticals, Inc.772c86d7-10a4-48c5-8c19-f8aac68f5ab42026-01-06Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
ALYACEN 1/35NORETHINDRONE AND ETHINYL ESTRADIOLProficient Rx LPfa32e05b-c86d-4743-aee5-be3fc515152b2026-01-01Warnings, Adverse reactionsExact identifier
rxcui: 748797
drospirenone and ethinyl estradiolDROSPIRENONE AND ETHINYL ESTRADIOLGlenmark Pharmaceuticals Inc., USA6d85f252-307c-4aa8-9572-1e74c98192832025-12-12Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
ENSKYCEDESOGESTREL AND ETHINYL ESTRADIOLLupin Pharmaceuticals, Inc.799fa1d8-4e7b-4b5e-844d-d638896a4b022025-12-12Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
Levonorgestrel and Ethinyl Estradiol and Ethinyl EstradiolLEVONORGESTREL AND ETHINYL ESTRADIOLLupin Pharmaceuticals, Inc.7d82aa5d-aee9-4c72-9b9b-af7adad21f4c2025-12-11Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 242297
Norgestimate and ethinyl estradiolNORGESTIMATE AND ETHINYL ESTRADIOLLupin Pharmaceuticals, Inc.6e8bec6f-17ba-4b37-ae6c-07657815f2482025-12-09Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
TRI-LO-MARZIANORGESTIMATE AND ETHINYL ESTRADIOLLupin Pharmaceuticals, Inc.bc402baa-5de4-4149-9857-081a9b4eb2802025-12-09Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
Norgestimate and Ethinyl EstradiolNORGESTIMATE AND ETHINYL ESTRADIOLLupin Pharmaceuticals, Inc.c25cd86c-2940-475a-9628-ee75b0294e8d2025-12-09Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797

Reported adverse events (FAERS/openFDA)#

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