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 2 of 23 · 446 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NORGESTRELNORGESTRELWalgreen Company4d882142-e253-42d3-87b2-a4f92ce821622026-07-09WarningsExact identifier
unii: 3J8Q1747Z2
Artificial TearsARTIFICIAL TEARSAvPAKf18bebf2-1936-658f-e053-2a95a90a50122026-07-07WarningsExact identifier
unii: 3NXW29V3WO
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
Rohto Sun and SportHYPROMELLOSE, POVIDONEThe Mentholatum Company8bcc8882-b886-4b55-9bc4-d4b92a41358f2026-06-19WarningsExact identifier
unii: 3NXW29V3WO
Rohto Dual Light ReliefHYPROMELLOSE, POVIDONEThe Mentholatum Company1b597f83-d7f1-cf93-e063-6394a90a99f72026-06-19WarningsExact identifier
unii: 3NXW29V3WO
Visine Red Eye Total Comfort Multi-SymptomTETRAHYDROZOLINE HYDROCHLORIDE, POLYETHYLENE GLYCOL 400, AND ZINC SULFATE, UNSPECIFIED FORMKenvue Brands LLC5747edef-7a87-41d7-9594-6c78508b9ba22026-06-11WarningsExact identifier
unii: B697894SGQ
GUNA-BOWELALOE - ALUMINUM OXIDE - BRYONIA ALBA ROOT - CHELIDONIUM MAJUS - CHOLECALCIFEROL - COLLINSONIA - FRANGULA ALNUS BARK - NIACIN - PANTOTHENIC ACID - POTASSIUM CARBONATE - RHUBARB - SILYBUM MARIANUM SEED - SKATOLE - SODIUM CARBONATE - STRYCHNOS NUX-VOMICA SEED - SUS SCROFA COLON - SUS SCROFA RECTUM - TARAXACUM OFFICINALE - THIAMINE -Guna spa75465821-a889-4697-b470-e9588a5232052026-06-10WarningsExact identifier
unii: LMI26O6933
Borago NicotianaBORAGO NICOTIANAUriel Pharmacy Inc.306f9eee-877b-46ee-9a36-894fa321b3d32026-06-05WarningsExact identifier
unii: LMI26O6933
VitaPhyte Redness Reliever Lubricant Eye DropsREDNESS RELIEVER LUBRICANT EYE DROPSGuangzhou Liyan Cosmetics Technology Co., Ltd.53d4e9b0-c9a0-797a-e063-6294a90ad0cf2026-06-04WarningsExact identifier
unii: B697894SGQ
Rohto Digi-EyeHYPROMELLOSE, TETRAHYDROZOLINE HYDROCHLORIDEThe Mentholatum Company5d6f37b9-b568-4cb6-92de-eb40779f3f8c2026-06-03WarningsExact identifier
unii: 3NXW29V3WO
Visine Red Eye Hydrating Comfort Eye DropsTETRAHYDROZOLINE HYDROCHLORIDE AND POLYETHYLENE GLYCOL 400Savings Distributors LLC558178eb-1eec-af0f-e063-6394a90afad92026-06-01WarningsExact identifier
unii: B697894SGQ
Blink Triple Care Preservative FreePOLYETHYLENE GLYCOL 400Bausch & Lomb Incorporated65e67990-78b7-4ce9-963b-6bed3a6bed072026-05-27WarningsExact identifier
unii: B697894SGQ
TurqozNORGESTREL AND ETHINYL ESTRADIOLA-S Medication Solutionse7a05138-91a5-4c66-a915-614576e0805a2026-05-21Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
rxcui: 749786
rxcui: 311359
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
blink tearsPOLYETHYLENE GLYCOL 400Bausch & Lomb Incorporatedf1d07347-086f-43b2-aa5f-910764fc666e2026-05-13WarningsExact identifier
unii: B697894SGQ
GoodSense Eye Drops Advanced Relief MoisturizerDEXTRAN, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCLPreferred PHarmaceuticals Inc.011473a8-26d5-4661-b3c0-745f9b6aa1d82026-04-29WarningsExact identifier
unii: B697894SGQ

Reported adverse events (FAERS/openFDA)#

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