FDA.reportPublic FDA data

NDC 68180-876-11 - NORETHINDRONE

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
68180-876
Requested NDC
68180-876-11
Package NDCs from labels
68180-876-73, 68180-876-13, 68180-876-11
Manufacturer
Proficient Rx LP
Effective date
2026-01-01
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
NORETHINDRONE - Proficient Rx LPProficient Rx LP2026-01-01HUMAN PRESCRIPTION DRUG LABEL
NORETHINDRONE - Lupin Pharmaceuticals, Inc. | LUPIN LIMITEDLupin Pharmaceuticals, Inc. | LUPIN LIMITED2025-02-25HUMAN PRESCRIPTION DRUG LABEL
NORETHINDRONE - A-S Medication SolutionsA-S Medication Solutions2025-02-18HUMAN PRESCRIPTION DRUG LABEL
NORETHINDRONE - Lupin Pharmaceuticals, Inc. | LUPIN LIMITEDLupin Pharmaceuticals, Inc. | LUPIN LIMITED2023-12-13HUMAN PRESCRIPTION DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unitNational Council for Prescription Drug Programs2012-07-24Indexing - Billing Unit

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68180-876-73NORETHINDRONE28 in 1 BLISTER PACKTABLET285
68180-876-73NORETHINDRONE3 in 1 CARTONTABLET35

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68180-876NORETHINDRONE TABLET [LUPIN PHARMACEUTICALS, INC.]5Current NDC, Legacy NDC, 2 package rows20250227_121fbf86-1d76-4579-be2f-be9a957b23ab.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68180-876-11EA - Each68180-87648bbc9ef-a39b-4026-8d14-2d679bd498fe12012-07-24
68180-876-13EA - Each68180-876858234e4-0c1f-4e3c-9ca9-8c77ea87104912012-07-24
68180-876-71EA - Each68180-876618f4a6c-e98e-4d4c-b890-21b068a35c7912021-05-05
68180-876-73EA - Each68180-876ae51c471-36c3-4ba3-a048-08495240fc9d12021-05-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NORETHINDRONEACTIVE INGREDIENTT18F433X4SNORETHINDRONE TABLET [LUPIN PHARMACEUTICALS, INC.]6
NORETHINDRONEACTIVE MOIETYT18F433X4SNORETHINDRONE TABLET [LUPIN PHARMACEUTICALS, INC.]6
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKNORETHINDRONE TABLET [LUPIN PHARMACEUTICALS, INC.]6
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GNORETHINDRONE TABLET [LUPIN PHARMACEUTICALS, INC.]6
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8NORETHINDRONE TABLET [LUPIN PHARMACEUTICALS, INC.]6
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XNORETHINDRONE TABLET [LUPIN PHARMACEUTICALS, INC.]6
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30NORETHINDRONE TABLET [LUPIN PHARMACEUTICALS, INC.]6
POVIDONE K30INACTIVE INGREDIENTU725QWY32XNORETHINDRONE TABLET [LUPIN PHARMACEUTICALS, INC.]6
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJNORETHINDRONE TABLET [LUPIN PHARMACEUTICALS, INC.]6

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 2 · 27 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Caldesene BabySTARCH, CORN AND ZINC OXIDEInsight Pharmaceuticals LLC9f12dee2-7afa-45e9-a729-0fd42bb777152026-04-22WarningsExact identifier
unii: O8232NY3SJ
Caldesene Medicated ProtectingCORNSTARCH AND ZINC OXIDEInsight Pharmaceuticals LLCffc92a0f-a7cf-4a46-b2f1-089df2bbb96b2026-04-22WarningsExact identifier
unii: O8232NY3SJ
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
Lotrimin Daily Sweat and Odor ControlTOPICAL STARCHBayer HealthCare LLC.9ec5c80d-b550-496f-e053-2a95a90a54892026-01-16WarningsExact identifier
unii: O8232NY3SJ
NORETHINDRONENORETHINDRONEProficient Rx LPbbd54f1e-2d48-4efa-a57e-7fa7b478c4572026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA091325
ndc (package): 82804-175-28
ndc (product): 82804-175
rxcui: 748961
rxcui: 198042
spl id: bbd54f1e-2d48-4efa-a57e-7fa7b478c457
spl set id: bbd54f1e-2d48-4efa-a57e-7fa7b478c457
unii: T18F433X4S
Medicated Cornstarch Baby PowderACTIVE CORN STARCHDavion, Inc.e39032d1-c8cd-4a41-af10-126970b8ad382025-12-29WarningsExact identifier
unii: O8232NY3SJ
JencyclaNORETHINDRONELupin Pharmaceuticals, Inc.e91e7bdd-2984-4332-9b0b-04322792d7f62025-12-08Warnings, Adverse reactionsExact identifier
rxcui: 748961
rxcui: 198042
unii: T18F433X4S
DEBLITANENORETHINDRONENorthstar Rx LLCe75367ff-78af-4bd2-a99d-d291cb1d21eb2025-12-05Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748961
rxcui: 198042
SHAROBELNORETHINDRONENorthstar Rx LLCa96f5194-ad2a-4783-a9a9-22a288caff252025-12-05Warnings, Adverse reactionsExact identifier
rxcui: 748961
rxcui: 198042
MELEYANORETHINDRONEXiromed LLC534c5717-382c-4109-3208-e21b32e4c4c92025-03-06Warnings, Adverse reactionsExact identifier
rxcui: 748961
rxcui: 198042
unii: T18F433X4S
NORETHINDRONENORETHINDRONELupin Pharmaceuticals, Inc.121fbf86-1d76-4579-be2f-be9a957b23ab2025-02-25Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA091325
ndc (package): 68180-876-73
ndc (product): 68180-876
rxcui: 748961
rxcui: 198042
spl id: 21d08d75-2957-4610-94c1-76c844ba2f1b
spl set id: 121fbf86-1d76-4579-be2f-be9a957b23ab
unii: T18F433X4S
NORETHINDRONENORETHINDRONEA-S Medication Solutions70231aa1-9dd2-420f-9cb3-432d3c2477d12025-02-18Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA091325
ndc (package): 50090-6161-0
ndc (product): 50090-6161
rxcui: 748961
rxcui: 198042
spl id: 9dc94f9a-0113-49fe-9500-2a96808b9888
spl set id: 70231aa1-9dd2-420f-9cb3-432d3c2477d1
unii: T18F433X4S
OrquideaNORETHINDRONEXiromed, LLC6e9f61a1-93ff-291a-bea8-9307a3b0378e2025-01-29Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748961
rxcui: 198042
unii: T18F433X4S
AffodelNORETHINDRONENaari Pte. Limited8ec64ec8-fbc9-440d-9838-654a605d57da2024-04-22Warnings, Adverse reactionsExact identifier
rxcui: 748961
rxcui: 198042
unii: T18F433X4S
Nora BENORETHINDRONETeva Pharmaceuticals, Inc.426ac898-7745-4645-bf9b-bae319e260e82024-04-02Warnings, Adverse reactionsExact identifier
rxcui: 748961
rxcui: 198042
unii: T18F433X4S
CAMILANORETHINDRONEDr. Reddy's Labratories Inc.59985565-af09-21ba-0336-3f6db7711bd12024-04-01Warnings, Adverse reactionsExact identifier
rxcui: 748961
rxcui: 198042
unii: T18F433X4S
Pure Cornstarch BabyCORN STARCHWalgreen Companyd0e9bd13-b568-4f7e-b036-8d23e71ad8bf2024-03-25WarningsExact identifier
unii: O8232NY3SJ
ERRINNORETHINDRONEDr. Reddy's Labratories Inc.df29577b-c2f0-bea8-b048-7719972707aa2024-03-01Warnings, Adverse reactionsExact identifier
rxcui: 748961
rxcui: 198042
unii: T18F433X4S
ERRINNORETHINDRONEProficient Rx LP904899f2-9c54-44d2-901e-47e8945715002024-01-01Warnings, Adverse reactionsExact identifier
rxcui: 748961
rxcui: 198042
unii: T18F433X4S

Reported adverse events (FAERS/openFDA)#

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