FDA.reportPublic FDA data

Cevimeline Hydrochloride

Product NDC
59651-422
11-digit product format
596510422
Labeler code
59651
Product ID
59651-422_d08d8aa5-76a4-417a-a308-7d195865522f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cevimeline Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA215056
Marketing category
ANDA
Marketing start
2023-04-18
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
2026-12-31
Current FDA listing
Yes

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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
unfinished productproduct59651-422UNFINISHEDActive or certified unfinished drug listing2026-07-31
unfinished packagepackage59651-42259651-422-15UNFINISHEDActive or certified unfinished drug listing2026-07-31

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
A215056-001CEVIMELINE HYDROCHLORIDECEVIMELINE HYDROCHLORIDE30MGCAPSULE / ORALAB2023-04-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A215056-001AB

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 22:54:322026-06A215056-001CEVIMELINE HYDROCHLORIDE30MGCAPSULE / ORALAB2023-04-18a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A215056-001AB1a50c72e98297…

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cevimeline HydrochlorideCEVIMELINE HYDROCHLORIDEBryant Ranch Prepack71ada1b0-3344-4202-9277-57f1a37402c12025-11-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215056
application number: ANDA215056
Cevimeline HydrochlorideCEVIMELINE HYDROCHLORIDEAurobindo Pharma Limitedd08d8aa5-76a4-417a-a308-7d195865522f2023-04-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215056
application number: ANDA215056
ndc (product): 59651-422

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CEVIMELINE HYDROCHLORIDE30 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
P81Q6V85NPInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
309140Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
d08d8aa5-76a4-417a-a308-7d195865522fAvailable on FDA.report

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59651-422-01Cevimeline Hydrochloride100 in 1 BOTTLECAPSULE1001
59651-422-05Cevimeline Hydrochloride500 in 1 BOTTLECAPSULE5001

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59651-422-01EA - Each59651-42269aee4e3-3e76-46de-a861-ab67f957004112023-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59651-422CEVIMELINE HYDROCHLORIDE CAPSULE [AUROBINDO PHARMA LIMITED]1Current NDC, 2 package rows20230425_d08d8aa5-76a4-417a-a308-7d195865522f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309140cevimeline HCl 30 MG Oral CapsulePSN71ada1b0-3344-4202-9277-57f1a37402c1100
309140cevimeline hydrochloride 30 MG Oral CapsuleSCD71ada1b0-3344-4202-9277-57f1a37402c1100
309140cevimeline HCl 30 MG Oral CapsulePSNd08d8aa5-76a4-417a-a308-7d195865522f1
309140cevimeline hydrochloride 30 MG Oral CapsuleSCDd08d8aa5-76a4-417a-a308-7d195865522f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
59651-422-0159651042201100 CAPSULE in 1 BOTTLE (59651-422-01) 100 capsule2023-04-18NoNoCurrent
59651-422-0559651042205500 CAPSULE in 1 BOTTLE (59651-422-05) 500 capsule2023-04-18NoNoCurrent
59651-422-15596510422151500 CAPSULE in 1 BAG (59651-422-15)1500 capsule18-APR-23Current