FDA.reportPublic FDA data

NDC 68180-877-11 - Jencycla

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
68180-877
Requested NDC
68180-877-11
Package NDCs from labels
68180-877-73, 68180-877-11, 68180-877-13
Manufacturer
Lupin Pharmaceuticals, Inc. | LUPIN LIMITED
Effective date
2025-12-08
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Jencycla - Lupin Pharmaceuticals, Inc. | LUPIN LIMITEDLupin Pharmaceuticals, Inc. | LUPIN LIMITED2025-12-08HUMAN PRESCRIPTION DRUG LABEL
Jencycla - Lupin Pharmaceuticals, Inc. | LUPIN LIMITEDLupin Pharmaceuticals, Inc. | LUPIN LIMITED2020-06-30HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68180-877-73Jencycla1 in 1 CARTONTABLET16
68180-877-73Jencycla28 in 1 BLISTER PACKTABLET286

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68180-877JENCYCLA (NORETHINDRONE) TABLET [LUPIN PHARMACEUTICALS, INC.]5Current NDC, Legacy NDC, 2 package rows20250524_e91e7bdd-2984-4332-9b0b-04322792d7f6.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68180-877-11EA - Each68180-8779fedc298-dc23-41c5-961e-550948b1c2be12013-06-04
68180-877-13EA - Each68180-8775025bc0a-f3fa-4cfd-b856-15740bc42d1212013-06-04
68180-877-71EA - Each68180-87788edc585-1515-4208-879d-2c97bc1513dc12020-08-06
68180-877-73EA - Each68180-877d231dd5e-3f0f-497b-9206-c0be1eddd6d612020-08-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NORETHINDRONEACTIVE INGREDIENTT18F433X4SJENCYCLA (NORETHINDRONE) TABLET [LUPIN PHARMACEUTICALS, INC.]7
NORETHINDRONEACTIVE MOIETYT18F433X4SJENCYCLA (NORETHINDRONE) TABLET [LUPIN PHARMACEUTICALS, INC.]7
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKJENCYCLA (NORETHINDRONE) TABLET [LUPIN PHARMACEUTICALS, INC.]7
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GJENCYCLA (NORETHINDRONE) TABLET [LUPIN PHARMACEUTICALS, INC.]7
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDJENCYCLA (NORETHINDRONE) TABLET [LUPIN PHARMACEUTICALS, INC.]7
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30JENCYCLA (NORETHINDRONE) TABLET [LUPIN PHARMACEUTICALS, INC.]7
POVIDONEINACTIVE INGREDIENTFZ989GH94EJENCYCLA (NORETHINDRONE) TABLET [LUPIN PHARMACEUTICALS, INC.]7
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2JENCYCLA (NORETHINDRONE) TABLET [LUPIN PHARMACEUTICALS, INC.]7

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 5 · 84 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Leader Artificial Tears 15 mLPOLYVINYL ALCOHOL, POVIDONECardinal Health8cccc589-3a8e-baad-e053-2a95a90ab8c72026-09-09WarningsExact identifier
unii: FZ989GH94E
FRESHKOTE PRESERVATIVE FREE LUBRICANT EYE DROPSPOVIDONE, POLYVINYL ALCOHOL SOLUTIONHarrow Eye, LLC049e9cc9-0663-53bc-e063-6294a90a2c4f2026-09-04WarningsExact identifier
unii: FZ989GH94E
Rohto Optic GlowNAPHAZOLINE HYDROCHLORIDE, POVIDONE, PROPYLENE GLYCOLThe Mentholatum Companydf9c5f7c-96e6-4b2b-b8cb-21a6a3342dff2026-08-20WarningsExact identifier
unii: FZ989GH94E
Rohto Preservative Free Dry AidPOVIDONE, PROPYLENE GLYCOLThe Mentholatum Companyf4b1974c-2412-45f6-b79d-88b8a0bcb6082026-08-18WarningsExact identifier
unii: FZ989GH94E
Rohto Dry-AidPOVIDONE, PROPYLENE GLYCOLThe Mentholatum Company8ea5c6c9-48f4-406a-a2cb-9280c546d87d2026-08-18WarningsExact identifier
unii: FZ989GH94E
GOOD NEIGHBOR PHARMACY ARTIFICAL TEARS LUBRICANT EYE DROPSPOLYVINYL ALCOHOL, POVIDONEAmerisourceBergence6852a8-c5e6-403d-a7b4-a2e85d1ebb1f2026-07-22WarningsExact identifier
unii: FZ989GH94E
Rohto Sun and SportHYPROMELLOSE, POVIDONEThe Mentholatum Company8bcc8882-b886-4b55-9bc4-d4b92a41358f2026-06-19WarningsExact identifier
unii: FZ989GH94E
Rohto Dual Light ReliefHYPROMELLOSE, POVIDONEThe Mentholatum Company1b597f83-d7f1-cf93-e063-6394a90a99f72026-06-19WarningsExact identifier
unii: FZ989GH94E
RippleGLYCERIN, POVIDONECorneaCare Inc3b5ba197-d501-681e-e063-6294a90aefb52026-05-24WarningsExact identifier
unii: FZ989GH94E
iVIZIA Lubricant Eye GelPOVIDONEThea Pharma Inc.1f06ca1a-5270-9a82-e063-6294a90aed642026-04-29WarningsExact identifier
unii: FZ989GH94E
GoodSense Eye Drops Advanced Relief MoisturizerDEXTRAN, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCLPreferred PHarmaceuticals Inc.011473a8-26d5-4661-b3c0-745f9b6aa1d82026-04-29WarningsExact identifier
unii: FZ989GH94E
FreshKote Preservative Free Lubricant Eye DropsPOVIDONE, POLYVINYL ALCOHOLEyevance Pharmaceuticalsf51c50c3-43ae-4169-9d2b-22b239461dd12026-04-08WarningsExact identifier
unii: FZ989GH94E
Leader Advanced Relief Eye DropsDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCLCardinal Health5c5d6c13-9b51-48f0-8627-b60b0f707fd32026-03-12WarningsExact identifier
unii: FZ989GH94E
GoodSense Eye Drops Advanced Relief MoisturizerDEXTRAN, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCLSportpharm LLC8d58dcbb-72a0-41f0-9eeb-613072a6d7ae2026-02-06WarningsExact identifier
unii: FZ989GH94E
MINIDROPSLUBRICANT EYE DROPSOptics Laboratory, Incc13c5f91-50df-471c-a7c9-1747a2ac12502026-02-03WarningsExact identifier
unii: FZ989GH94E
NorethindroneNORETHINDRONEGlenmark Pharmaceuticals Inc., USA0d2f8fea-3675-40d2-afd9-9fcb148dbd4b2026-01-31Warnings, Adverse reactionsExact identifier
rxcui: 748961
rxcui: 198042
unii: T18F433X4S
HEATHERNORETHINDRONEGlenmark Pharmaceuticals Inc., USA35b5ddb5-1729-4588-b2a2-ead56d78b6f92026-01-23Warnings, Adverse reactionsExact identifier
rxcui: 748961
rxcui: 198042
unii: T18F433X4S
NORETHINDRONENORETHINDRONEProficient Rx LPbbd54f1e-2d48-4efa-a57e-7fa7b478c4572026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748961
rxcui: 198042
unii: T18F433X4S
CVS Advanced Eye DropsDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HYDROCHLORIDECVS Pharmacy, Inc.f74a2fca-902c-f68a-e053-6394a90abb882025-12-30WarningsExact identifier
unii: FZ989GH94E
Good Sense Artificial TearsPOLYVINYL ALCOHOL, POVIDONEGeiss, Destin & Dunn, Inc.9b243301-2e4b-5706-e053-2995a90a9b902025-12-30WarningsExact identifier
unii: FZ989GH94E

Reported adverse events (FAERS/openFDA)#

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