FDA.reportPublic FDA data

NDC 0555-9049-79 - Cryselle

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
0555-9049
Requested NDC
0555-9049-79
Package NDCs from labels
0555-9049-79, 0555-9049-58
Manufacturer
A-S Medication Solutions
Effective date
2024-05-07
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Cryselle - A-S Medication SolutionsA-S Medication Solutions2024-05-07HUMAN PRESCRIPTION DRUG LABEL
Cryselle ® (norgestrel and ethinyl estradiol tablets USP)Preferred Pharmaceuticals Inc.2024-04-08HUMAN PRESCRIPTION DRUG LABEL
Cryselle ® (norgestrel and ethinyl estradiol tablets USP)RPK Pharmaceuticals, Inc.2023-06-07HUMAN PRESCRIPTION DRUG LABEL
Cryselle - Proficient Rx LPProficient Rx LP2023-05-01HUMAN PRESCRIPTION DRUG LABEL
Cryselle ® (norgestrel and ethinyl estradiol tablets USP)Teva Pharmaceuticals USA, Inc.2022-07-28HUMAN PRESCRIPTION DRUG LABEL
Cryselle - REMEDYREPACK INC.REMEDYREPACK INC.2020-03-27HUMAN PRESCRIPTION DRUG LABEL
CRYSELLE™ - 28 TABLETS (NORGESTREL AND ETHINYL ESTRADIOL TABLETS, USP)Physicians Total Care, Inc.2011-01-20HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0555-9049-58Cryselle6 in 1 CARTONKIT615
0555-9049-79Cryselle1 in 1 BLISTER PACKKIT115
0555-9049-79Cryselle1 in 1 POUCHKIT115

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0555-9049CRYSELLE (NORGESTREL AND ETHINYL ESTRADIOL) KIT [TEVA PHARMACEUTICALS USA, INC.]14Current NDC, Legacy NDC, 3 package rows20220827_ee6be128-d494-4361-9a0d-341c0eee3587.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0555-9049-58EA - Each0555-9049d363784a-eb4d-4cbd-88b6-3017430508e912013-02-13
0555-9049-79EA - Each0555-904987c812cf-97ed-458d-8785-498ab7bfb13d12017-03-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ETHINYL ESTRADIOLACTIVE INGREDIENT423D2T571UCRYSELLE (NORGESTREL AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES INC.]3
NORGESTRELACTIVE INGREDIENT3J8Q1747Z2CRYSELLE (NORGESTREL AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES INC.]3
ETHINYL ESTRADIOLACTIVE MOIETY423D2T571UCRYSELLE (NORGESTREL AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES INC.]3
NORGESTRELACTIVE MOIETY3J8Q1747Z2CRYSELLE (NORGESTREL AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES INC.]3
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933CRYSELLE (NORGESTREL AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES INC.]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCRYSELLE (NORGESTREL AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES INC.]3
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GCRYSELLE (NORGESTREL AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES INC.]3
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDCRYSELLE (NORGESTREL AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES INC.]3
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8CRYSELLE (NORGESTREL AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES INC.]3
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6CRYSELLE (NORGESTREL AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES INC.]3
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCRYSELLE (NORGESTREL AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES INC.]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CRYSELLE (NORGESTREL AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES INC.]3
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQCRYSELLE (NORGESTREL AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES INC.]3
POLYETHYLENE GLYCOL 8000INACTIVE INGREDIENTQ662QK8M3BCRYSELLE (NORGESTREL AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES INC.]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCRYSELLE (NORGESTREL AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES INC.]3
ETHINYL ESTRADIOLACTIVE INGREDIENT423D2T571UCRYSELLE (NORGESTREL AND ETHINYL ESTRADIOL) KIT [PHYSICIANS TOTAL CARE, INC.]1
NORGESTRELACTIVE INGREDIENT3J8Q1747Z2CRYSELLE (NORGESTREL AND ETHINYL ESTRADIOL) KIT [PHYSICIANS TOTAL CARE, INC.]1
ETHINYL ESTRADIOLACTIVE MOIETY423D2T571UCRYSELLE (NORGESTREL AND ETHINYL ESTRADIOL) KIT [PHYSICIANS TOTAL CARE, INC.]1
NORGESTRELACTIVE MOIETY3J8Q1747Z2CRYSELLE (NORGESTREL AND ETHINYL ESTRADIOL) KIT [PHYSICIANS TOTAL CARE, INC.]1
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933CRYSELLE (NORGESTREL AND ETHINYL ESTRADIOL) KIT [PHYSICIANS TOTAL CARE, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCRYSELLE (NORGESTREL AND ETHINYL ESTRADIOL) KIT [PHYSICIANS TOTAL CARE, INC.]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GCRYSELLE (NORGESTREL AND ETHINYL ESTRADIOL) KIT [PHYSICIANS TOTAL CARE, INC.]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDCRYSELLE (NORGESTREL AND ETHINYL ESTRADIOL) KIT [PHYSICIANS TOTAL CARE, INC.]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8CRYSELLE (NORGESTREL AND ETHINYL ESTRADIOL) KIT [PHYSICIANS TOTAL CARE, INC.]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOCRYSELLE (NORGESTREL AND ETHINYL ESTRADIOL) KIT [PHYSICIANS TOTAL CARE, INC.]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCRYSELLE (NORGESTREL AND ETHINYL ESTRADIOL) KIT [PHYSICIANS TOTAL CARE, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CRYSELLE (NORGESTREL AND ETHINYL ESTRADIOL) KIT [PHYSICIANS TOTAL CARE, INC.]1
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1ACRYSELLE (NORGESTREL AND ETHINYL ESTRADIOL) KIT [PHYSICIANS TOTAL CARE, INC.]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCRYSELLE (NORGESTREL AND ETHINYL ESTRADIOL) KIT [PHYSICIANS TOTAL CARE, INC.]1

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 23 · 449 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
Dr.Harry EYES PROTECTIONPOLYETHYLENE GLYCOL 400 1% EYES PROTECTIONWenzhou Yuyuan Pharmaceutical Co., Ltd.5a9fe033-89d3-da62-e063-6294a90a45032026-09-03WarningsExact identifier
unii: B697894SGQ
SprintecNORGESTIMATE AND ETHINYL ESTRADIOLPreferred Pharmaceuticals, Inc.90240210-0bca-4a55-99dc-19f2b40d8e3f2026-08-31Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
BMNP ALUMINUM OXIDEALUMINUM OXIDETotal Operations Management LLC DBA:Bestmade Natural Products Micro5a5ad83a-0ecb-21fa-e063-6294a90a14222026-08-31WarningsExact identifier
unii: LMI26O6933
Levonorgestrel and Ethinyl EstradiolLEVONORGESTREL AND ETHINYL ESTRADIOLLupin Pharmaceuticals, Inc.58e85e02-93e7-42ba-b8f5-a36290c684232026-08-31Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
SLYNDDROSPIRENONEExeltis USA, Inc.db32bc55-f295-4d87-9dbb-0a2f45573dcf2026-08-27Warnings, Adverse reactionsExact identifier
rxcui: 748797
Rohto All-In-OneHYPROMELLOSE, TETRAHYDROZOLINE HYDROCHLORIDE, ZINC SULFATEThe Mentholatum Company43e690e4-b381-46e3-838c-33aef5bdadde2026-08-20WarningsExact identifier
unii: 3NXW29V3WO
Leader Dry Eye Relief Eye DropsGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400CARDINAL HEALTH 110, LLC. DBA LEADER2ded4bda-b3c3-4521-8701-5c8446fd148b2026-08-17WarningsExact identifier
unii: B697894SGQ
unii: 3NXW29V3WO
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
Lipo-ChordACETICUM AC, ACETYLSAL AC, ADRENOCORTICOTROPHIN, ALUMINA, ARSENICUM ALB, BORAGO, CEANOTHUS, CHELIDONIUM MAJ, CHIONANTHUS, CHLORAMPHENICOLUM, CHLORPROMAZINUM, CHOLESTERINUM, CORTISONE ACETICUM, DAMIANA, FOLLICULINUM, FUMARICUM AC, KALI IOD, LYCOPODIUM, NAT SULPHURICUM, NUX VOM, OLEUM MORRHUAE, PETROLEUM, PHENACETINUM, PHOSPHORICUM AC, PHOSPHORUS, PLUMB MET, SACCHARUM OFF, SILICEA, TARAXACUM, THYROIDINUM.Energetix Corporation5c83cbd5-46fb-48a0-a739-ff9c81e7129c2026-08-11WarningsExact identifier
unii: LMI26O6933
Vac-ChordALUMINA, ARSENICUM ALBUM, BAPTISIA TINCTORIA, BELLADONNA, BOLDO, CALCAREA CARBONICA, CARDUUS MARIANUS, CHAMOMILLA, CHELIDONIUM MAJUS, ECHINACEA, HYDRASTIS CANADENSIS, LECITHIN, LEDUM PALUSTRE, LYCOPODIUM CLAVATUM, MERCURIUS SOLUBILIS, MORBILLINUM, PERTUSSINUM, PHYTOLACCA DECANDRA, PYROGENIUM, RHUS TOX, SILICEA, SULPHUR, TARAXACUM OFFICINALE, THUJA OCCIDENTALIS, THYROIDINUM.Energetix Corporation880ea1e6-8d4d-486e-9a8f-9d3158a996672026-08-11WarningsExact identifier
unii: LMI26O6933
Tox-ChordALFALFA, ALUMINA, BENZOICUM AC, CARBONEUM, CETRARIA, FOLLICULINUM, FUCUS, FUMARICUM AC, HEPAR SUIS, KALI CARB, KREOSOTUM, NAT MUR, PARAFFINUM, PETROLEUM, PHOSPHORICUM AC, PHOS, PIX LIQUIDA, PLANTAGO, PLUMB MET, PULSATILLA, RADIUM BROM, RESORCINUM, SALOL, SILICEA, SYMPHYTUM, TABACUM, TEREBINTHINA, THYROIDINUM, TRITICUM, ZINC OXYD.Energetix Corporationb06b4794-e5bb-4ccd-87fd-37afca7b0f982026-08-11WarningsExact identifier
unii: LMI26O6933
MycoCan-ChordALUMINA, AVENA SATIVA, BORAX, CANDIDA ALBICANS, CARBOLICUM ACIDUM, CEANOTHUS AMERICANUS, ECHINACEA, GAULTHERIA PROCUMBENS, GLANDULA SUPRARENALIS SUIS, HYDRASTIS CANADENSIS, LINUM USITATISSIMUM, LITHIUM CARBONICUM, MEDULLA OSSIS SUIS, NATRUM MURIATICUM, PHOSPHORICUM ACIDUM, PHYTOLACCA DECANDRA, SARCOLACTICUM ACIDUM, SEPIA, SILICEA, SOLIDAGO VIRGAUREA, TELLURIUM METALLICUM, TEUCRIUM MARUM, ZINCUM METALLICUMEnergetix Corporation227199f8-a45e-44ff-892d-ade4fefea3542026-08-11WarningsExact identifier
unii: LMI26O6933
Metal-ChordALLIUM CEPA, ALLIUM SATIVUM, ALPHA-LIPOICUM ACIDUM, ALUMINA, ARSENICUM METALLICUM, BERBERIS VULGARIS, CADMIUM METALLICUM, CARDUUS MARIANUS, CETRARIA ISLANDICA, CUPRUM METALLICUM, CYSTEINUM, GLYCYRRHIZA GLABRA, HEPAR SUIS, LAPPA MAJOR, LYCOPODIUM CLAVATUM, MERCURIUS SOLUBILIS, NUX VOMICA, PLANTAGO MAJOR, PLUMBUM METALLICUM, PYRIDOXINUM HYDROCHLORICUM, SELENIUM METALLICUM, STILLINGIA SYLVATICA, THYROIDINUM, TRIFOLIUM PRATENSE, ZINGIBER OFFICINALEEnergetix Corporationea4d26a8-acf2-46ed-9a69-df7764cc4cfd2026-08-11WarningsExact identifier
unii: LMI26O6933
SYSTANE HYDRATION PF PRESERVATIVE FREEPOLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOLAlcon Laboratories, Inc.8936f66f-10fe-44ab-a26e-dd8b05dfa9972026-08-10WarningsExact identifier
unii: B697894SGQ
Dr. Shitong Photon Energy Eye Care LiquidTETRAHYDROZOLINE HCL 0.05% HYPROMELLOSE 0.3% DR. SHITONG PHOTON ENERGY EYE CARE LIQUIDWenzhou Yuyuan Pharmaceutical Co., Ltd.58ace434-55ef-17ef-e063-6294a90aa8782026-08-10WarningsExact identifier
unii: 3NXW29V3WO
Daily Oral ContraceptiveNORGESTRELCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED20477912-c1d6-4190-8f6e-00fb122134a12026-08-06WarningsExact identifier
unii: 3J8Q1747Z2
Leader Lubricant Eye Drops 30ctPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLCARDINAL HEALTH 110, LLC. DBA LEADER8df69f2c-40c4-245c-e053-2a95a90a54062026-08-05WarningsExact identifier
unii: B697894SGQ
DROSPIRENONE AND ETHINYL ESTRADIOLDROSPIRENONE AND ETHINYL ESTRADIOLRedpharm Drug57d1d945-9fc9-4e79-e063-6294a90a738a2026-07-30Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797

Reported adverse events (FAERS/openFDA)#

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