FDA.reportPublic FDA data

Evoxac

Product NDC
63395-201
11-digit product format
633950201
Labeler code
63395
Product ID
63395-201_24b744ff-3334-424d-9500-76dbfca5979a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
cevimeline hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Daiichi Sankyo, Inc.
Application
NDA020989
Marketing category
NDA
Marketing start
2000-01-12
Marketing end
2025-08-31
Substance
CEVIMELINE HYDROCHLORIDE
Active strength
30 mg/1
Pharmacologic classes
Cholinergic Muscarinic Agonists [MoA], Cholinergic Receptor Agonist [EPC]
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5ee6cfc6-9666-4038-bf74-eee52d7e4a72Product name420250331

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63395-201-132020-08-21C16284748780-1ab0e2407-2eee-f274-e053-dbdaa90a64710679dd4c-fece-4c6d-b273-2c62237e8973
63395-201-132020-07-22C16284748780-1ab0e2407-2eee-f274-e053-dbdaa90a64710679dd4c-fece-4c6d-b273-2c62237e8973

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63395-201-13EA - Each63395-2019fb1f160-a03b-4679-a812-d432f63322af12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CEVIMELINE HYDROCHLORIDEACTIVE INGREDIENTP81Q6V85NPEVOXAC (CEVIMELINE HYDROCHLORIDE) CAPSULE [DAIICHI SANKYO PHARMA DEVELOPMENT]3
CEVIMELINEACTIVE MOIETYK9V0CDQ56EEVOXAC (CEVIMELINE HYDROCHLORIDE) CAPSULE [DAIICHI SANKYO PHARMA DEVELOPMENT]3
CEVIMELINE HYDROCHLORIDEACTIVE INGREDIENTP81Q6V85NPEVOXAC (CEVIMELINE HYDROCHLORIDE) CAPSULE [STAT RX USA LLC]1
CEVIMELINEACTIVE MOIETYK9V0CDQ56EEVOXAC (CEVIMELINE HYDROCHLORIDE) CAPSULE [STAT RX USA LLC]1
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PEVOXAC (CEVIMELINE HYDROCHLORIDE) CAPSULE [STAT RX USA LLC]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XEVOXAC (CEVIMELINE HYDROCHLORIDE) CAPSULE [STAT RX USA LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30EVOXAC (CEVIMELINE HYDROCHLORIDE) CAPSULE [STAT RX USA LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63395-201EVOXAC (CEVIMELINE HYDROCHLORIDE) CAPSULE [DAIICHI SANKYO, INC.]14Legacy NDC20220608_0679dd4c-fece-4c6d-b273-2c62237e8973.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309140cevimeline HCl 30 MG Oral CapsulePSNbf6bebde-81ef-4a49-bd8b-2b7444f7adbf1
261361Evoxac 30 MG Oral CapsulePSNbf6bebde-81ef-4a49-bd8b-2b7444f7adbf1
261361cevimeline hydrochloride 30 MG Oral Capsule [Evoxac]SBDbf6bebde-81ef-4a49-bd8b-2b7444f7adbf1
309140cevimeline hydrochloride 30 MG Oral CapsuleSCDbf6bebde-81ef-4a49-bd8b-2b7444f7adbf1
261361Evoxac 30 MG Oral CapsuleSYbf6bebde-81ef-4a49-bd8b-2b7444f7adbf1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63395-201-1363395020113100 CAPSULE in 1 BOTTLE, PLASTIC (63395-201-13) 100 capsule2000-01-120000-00-00NoNoCurrent