FDA.reportPublic FDA data

Evoxac

Product NDC
63395-201
Requested package NDC
63395-201-13
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

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage63395-20163395-201-13DDiscontinued by firm2026-07-31

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N020989-002EVOXACCEVIMELINE HYDROCHLORIDE30MGCAPSULE / ORALABRLD, RS2000-01-11

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
N020989-002AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06N020989-002EVOXAC30MGCAPSULE / ORALABRLD, RS2000-01-11a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06N020989-002AB1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
cevimeline hydrochlorideCEVIMELINE HYDROCHLORIDECosette Pharmaceuticals, Inc.efc2bb24-4dda-4781-bef5-fcd9abf082dd2023-01-05Warnings, Adverse reactionsExact identifier
application applno (NDA): 020989
application number: NDA020989
EvoxacCEVIMELINE HYDROCHLORIDECosette Pharmaceuticals, Inc.dac32a9b-05b8-42c2-9a29-d885a92794562022-09-07Warnings, Adverse reactionsExact identifier
application applno (NDA): 020989
application number: NDA020989
CevimelineCEVIMELINESun Pharmaceutical Industries, Inc.773a19e8-4c3e-4414-99a6-aea98c9790ee2022-07-15Warnings, Adverse reactionsExact identifier
application applno (NDA): 020989
application number: NDA020989

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-dbdaa90a6471EVOXAC ® Capsules (cevimeline hydrochloride)
63395-201-132020-07-22C16284748780-1ab0e2407-2eee-f274-e053-dbdaa90a6471EVOXAC ® Capsules (cevimeline hydrochloride)

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 capsule2000-01-122025-08-31NoNoCurrent