FDA.reportPublic FDA data

NDC 68462-565-84 - Norgestimate and Ethinyl Estradiol

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
68462-565
Requested NDC
68462-565-84
Package NDCs from labels
68462-565-84, 68462-565-29
Manufacturer
Glenmark Pharmaceuticals Inc., USA | Glenmark Pharmaceuticals Limited
Effective date
2026-02-06
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Norgestimate and Ethinyl Estradiol - Glenmark Pharmaceuticals Inc., USA | Glenmark Pharmaceuticals LimitedGlenmark Pharmaceuticals Inc., USA | Glenmark Pharmaceuticals Limited2026-02-06HUMAN PRESCRIPTION DRUG LABEL
Norgestimate and Ethinyl Estradiol - Preferred Pharmaceuticals IncPreferred Pharmaceuticals Inc2023-10-04HUMAN PRESCRIPTION DRUG LABEL
Norgestimate and Ethinyl Estradiol - RPK Pharmaceuticals, Inc.RPK Pharmaceuticals, Inc.2023-06-07HUMAN PRESCRIPTION DRUG LABEL
Norgestimate and Ethinyl Estradiol - A-S Medication SolutionsA-S Medication Solutions2023-03-28HUMAN PRESCRIPTION DRUG LABEL
Norgestimate and Ethinyl Estradiol - Proficient Rx LPProficient Rx LP2022-04-01HUMAN PRESCRIPTION DRUG LABEL
Norgestimate and Ethinyl Estradiol - Preferred Pharmaceuticals Inc.Preferred Pharmaceuticals Inc.2019-03-11HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68462-565-29Norgestimate and Ethinyl Estradiol3 in 1 CARTONKIT317
68462-565-84Norgestimate and Ethinyl Estradiol1 in 1 BLISTER PACKKIT117

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68462-565NORGESTIMATE AND ETHINYL ESTRADIOL KIT [GLENMARK PHARMACEUTICALS INC., USA]14Current NDC, Legacy NDC, 2 package rows20230807_8b247e46-203e-4f5b-b5a7-cbd57341c735.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68462-565-29EA - Each68462-565ee40e381-3d5e-4572-b13c-8ebf29af1c6a12012-07-24
68462-565-84EA - Each68462-5658c297e84-c2b0-420d-918c-dbbb9b079d4512019-07-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ETHINYL ESTRADIOLACTIVE INGREDIENT423D2T571UNORGESTIMATE AND ETHINYL ESTRADIOL KIT [GLENMARK PHARMACEUTICALS INC., USA]8
NORGESTIMATEACTIVE INGREDIENTC291HFX4DYNORGESTIMATE AND ETHINYL ESTRADIOL KIT [GLENMARK PHARMACEUTICALS INC., USA]8
ETHINYL ESTRADIOLACTIVE MOIETY423D2T571UNORGESTIMATE AND ETHINYL ESTRADIOL KIT [GLENMARK PHARMACEUTICALS INC., USA]8
NORGESTIMATEACTIVE MOIETYC291HFX4DYNORGESTIMATE AND ETHINYL ESTRADIOL KIT [GLENMARK PHARMACEUTICALS INC., USA]8
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UNORGESTIMATE AND ETHINYL ESTRADIOL KIT [GLENMARK PHARMACEUTICALS INC., USA]8
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GNORGESTIMATE AND ETHINYL ESTRADIOL KIT [GLENMARK PHARMACEUTICALS INC., USA]8
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKNORGESTIMATE AND ETHINYL ESTRADIOL KIT [GLENMARK PHARMACEUTICALS INC., USA]8
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XNORGESTIMATE AND ETHINYL ESTRADIOL KIT [GLENMARK PHARMACEUTICALS INC., USA]8
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30NORGESTIMATE AND ETHINYL ESTRADIOL KIT [GLENMARK PHARMACEUTICALS INC., USA]8
POVIDONE K30INACTIVE INGREDIENTU725QWY32XNORGESTIMATE AND ETHINYL ESTRADIOL KIT [GLENMARK PHARMACEUTICALS INC., USA]8
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4NORGESTIMATE AND ETHINYL ESTRADIOL KIT [GLENMARK PHARMACEUTICALS INC., USA]8
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJNORGESTIMATE AND ETHINYL ESTRADIOL KIT [GLENMARK PHARMACEUTICALS INC., USA]8
TALCINACTIVE INGREDIENT7SEV7J4R1UNORGESTIMATE AND ETHINYL ESTRADIOL KIT [GLENMARK PHARMACEUTICALS INC., USA]8

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 42 · 827 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Muscle IcePHYTOLACCA DECANDRA, BELLIS PERENNIS, LEDUM PALUSTRE, RUTA GRAVEOLENS, SYMPHYTUM OFFICINALE, MAGNESIA PHOSPHORICA, SILICEA, MENTHOL (CRYSTALS)Peaceful Mountain, Inc.03b6e2a9-f335-4ae2-9011-80bd019afb722026-07-30WarningsExact identifier
unii: ETJ7Z6XBU4
HeadacheMELILOTUS OFFICINALIS, SPIGELIA ANTHELMIA, ALLIUM CEPA, BELLADONNA, BRYONIA (ALBA), CIMICIFUGA RACEMOSA, GELSEMIUM SEMPERVIRENS, GLONOINUM, MAGNESIA PHOSPHORICA, NUX VOMICA, SANGUINARIA CANADENSIS, SILICEA, TARENTULA CUBENSISBioActive Nutritionals, Inc.918bc478-78a2-41e1-b123-f5350cf8f43a2026-07-30WarningsExact identifier
unii: ETJ7Z6XBU4
norgestimate and ethinyl estradiolNORGESTIMATE AND ETHINYL ESTRADIOLPD-Rx Pharmaceuticals, Inc.2385591b-70ee-0577-e063-6394a90a93572026-07-29Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
PridICHTHAMMOL, CALCIUM SULFIDE, CALENDULA OFFICINALIS FLOWERING TOP, ARNICA MONTANA, ECHINACEA ANGUSTIFOLIA, SILICON DIOXIDE, SULFURHyland's Inc.49689eeb-7790-07f1-e063-6294a90a2df22026-07-16WarningsExact identifier
unii: ETJ7Z6XBU4
Leg Cramps PMOYSTER SHELL CALCIUM CARBONATE, CRUDE, CAUSTICUM, MATRICARIA RECUTITA, CINCHONA OFFICINALIS BARK, COPPER, LYCOPODIUM CLAVATUM SPORE, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, TOXICODENDRON PUBESCENS LEAF, SILICON DIOXIDE, AND SULFURHyland's Inc.b0574a7e-88fa-417e-b6d5-60ced59eba472026-07-15WarningsExact identifier
unii: ETJ7Z6XBU4
Etonogestrel and Ethinyl Estradiol VaginalETONOGESTREL AND ETHINYL ESTRADIOL VAGINALAvKARE05e172aa-e18a-427b-e063-6294a90ae22f2026-07-13Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
Jacksons Cell Salts SILICA 12X 12SILICEAZettl Health Inc.5647dafc-1fff-6a25-e063-6294a90a8b4f2026-07-10Exact identifier
unii: ETJ7Z6XBU4
Gwyn LoNORELGESTROMIN AND ETHINYL ESTRADIOLViatris Specialty LLCe92741f4-87fe-429f-b5b5-c558ed5f4fa92026-07-06Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
The Cell Salt Co. Daily Blend 12 in 1CALC FLUOR, CALC PHOS, CALC SULPH, FERRUM PHOS, KALI MUR, KALI PHOS, KALI SULPH, MAG PHOS, NAT MUR, NAT PHOS, NAT SULPH, SILICEAThe Cell Salt Company LLC55826f59-acf4-7370-e063-6394a90afed72026-07-01WarningsExact identifier
unii: ETJ7Z6XBU4
desogestrel and ethinyl estradiol and ethinyl estradiolDESOGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOLApotex Corp.5a179f7b-a718-494f-8c97-ece34f356ca72026-06-30Warnings, Adverse reactionsExact identifier
rxcui: 748797
TwirlaLEVONORGESTREL/ETHINYL ESTRADIOLAgile Therapeutics, Inc.bcaf8db0-1750-425d-b008-255b5e7a9cc62026-06-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
Bambusa StannumBAMBUSA STANNUMUriel Pharmacy Inc.a0d4d0ac-e2d2-4381-8f93-e417195218592026-06-30WarningsExact identifier
unii: ETJ7Z6XBU4
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: 749860
rxcui: 240128
H-Scars FormulaCALENDULA OFFICINALLIS, SILICEAHealing Natural Oils LLC8433ff00-d815-45e0-b0ec-1448668dd8f82026-06-16WarningsExact identifier
unii: ETJ7Z6XBU4
E-Z-GAS IIANTACID/ANTIFLATULENTE-Z-EM, INC.4e12e1cb-b033-076d-e054-00144ff8d46c2026-06-15WarningsExact identifier
unii: ETJ7Z6XBU4
BM BIO28 ALCOHOLCALC SULPH, CALC FLUOR, CALC PHOS, FERR PHOS, KALI MUR, KALI PHOS, KALI SULPH, MAG PHOS, NAT PHOS, NAT SULPH, NAT MUR, SILICEATotal Operations Management LLC DBA:Bestmade Natural Products Micro544b66c4-49df-556f-e063-6394a90af3ed2026-06-15WarningsExact identifier
unii: ETJ7Z6XBU4
BM Tooth RemineralizationCALC PHOS, CALC FLUOR, SILICEATotal Operations Management LLC DBA:Bestmade Natural Products Micro543bc298-ec32-38e9-e063-6394a90aac152026-06-14WarningsExact identifier
unii: ETJ7Z6XBU4
Nail Fungus Control Extra StrengthCALENDULA OFFICINALIS FLOWERING TOP, SILICON DIOXIDE, AND HYPERICUM PERFORATUMForces of Natured02b88a6-1999-4dcd-91b5-fad88a664fcb2026-06-14WarningsExact identifier
unii: ETJ7Z6XBU4