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

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 Identifiers#

Field, Values table
FieldValues
UniiP81Q6V85NP
Rxcui309140

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 capsule2023-04-18NoNoHistorical
59651-422-0559651042205500 CAPSULE in 1 BOTTLE (59651-422-05) 500 capsule2023-04-18NoNoHistorical