FDA.reportPublic FDA data

Nerlynx

Product NDC
70437-240
11-digit product format
704370240
Labeler code
70437
Product ID
70437-240_44eb88a3-0ac0-2880-e063-6394a90af02f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
neratinib
Dosage form
TABLET
Route
ORAL
Labeler
Puma Biotechnology, Inc.
Application
NDA208051
Marketing category
NDA
Marketing start
2017-07-17
Substance
NERATINIB MALEATE ANHYDROUS
Active strength
40 mg/1
Pharmacologic classes
Kinase Inhibitor [EPC], Kinase Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Nerlynx
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NERATINIB MALEATE ANHYDROUS40 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9RM7XY23ZS
Rxcui1940648, 1940654

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a0843f64-5a61-4b70-8974-8342d1b913c8Product name120170816

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70437-240-182020-02-07C16284748780-19d75b9d0-370c-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use NERLYNX safely and effectively. See full prescribing information for NERLYNX. NERLYNX ® (neratinib) tablets, for oral use Initial U.S. Approval: 2017
70437-240-262020-02-07C16284748780-19d75b9d0-370c-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use NERLYNX safely and effectively. See full prescribing information for NERLYNX. NERLYNX ® (neratinib) tablets, for oral use Initial U.S. Approval: 2017
70437-240-182020-01-31C16284748780-19d75b9d0-370c-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use NERLYNX safely and effectively. See full prescribing information for NERLYNX. NERLYNX ® (neratinib) tablets, for oral use Initial U.S. Approval: 2017
70437-240-262020-01-31C16284748780-19d75b9d0-370c-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use NERLYNX safely and effectively. See full prescribing information for NERLYNX. NERLYNX ® (neratinib) tablets, for oral use Initial U.S. Approval: 2017

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70437-240-18Nerlynx180 in 1 BOTTLETABLET18018
70437-240-18Nerlynx1 in 1 BOXTABLET118
70437-240-26Nerlynx126 in 1 BOTTLETABLET12618
70437-240-26Nerlynx1 in 1 BOXTABLET118
70437-240-33Nerlynx133 in 1 BOTTLETABLET13318
70437-240-33Nerlynx1 in 1 BOXTABLET118

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70437-240-18EA - Each70437-240910aa0ad-79cf-432f-9160-3a15c7b3a1ce12017-08-11
70437-240-33EA - Each70437-2402bf39616-cc43-4cb1-9923-a185be8e74d712021-06-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70437-240NERLYNX (NERATINIB) TABLET [PUMA BIOTECHNOLOGY, INC.]17Current NDC, Legacy NDC, 6 package rows20240327_d1e41dcf-e82a-47c2-a0ad-6c6eef621834.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1940648neratinib 40 MG Oral TabletPSNd1e41dcf-e82a-47c2-a0ad-6c6eef62183418
1940654NERLYNX 40 MG Oral TabletPSNd1e41dcf-e82a-47c2-a0ad-6c6eef62183418
1940654neratinib 40 MG Oral Tablet [Nerlynx]SBDd1e41dcf-e82a-47c2-a0ad-6c6eef62183418
1940648neratinib 40 MG Oral TabletSCDd1e41dcf-e82a-47c2-a0ad-6c6eef62183418
1940648neratinib 40 MG (as neratinib maleate 48.31 mg) Oral TabletSYd1e41dcf-e82a-47c2-a0ad-6c6eef62183418
1940654Nerlynx 40 MG (as neratinib maleate 48.31 MG) Oral TabletSYd1e41dcf-e82a-47c2-a0ad-6c6eef62183418

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70437-240-18704370240181 BOTTLE in 1 BOX (70437-240-18) / 180 TABLET in 1 BOTTLE1 bottle2017-07-170000-00-00NoNoCurrent
70437-240-26704370240261 BOTTLE in 1 BOX (70437-240-26) / 126 TABLET in 1 BOTTLE1 bottle2017-07-170000-00-00NoNoCurrent
70437-240-33704370240331 BOTTLE in 1 BOX (70437-240-33) / 133 TABLET in 1 BOTTLE1 bottle2017-07-170000-00-00NoNoCurrent