FDA.reportPublic FDA data

Cevimeline Hydrochloride

Product NDC
16571-657
11-digit product format
165710657
Labeler code
16571
Product ID
16571-657_640e50a9-48ba-45e3-a3cb-c14bb313cc4f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cevimeline Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Rising Pharma Holdings, Inc.
Application
ANDA203775
Marketing category
ANDA
Marketing start
2014-06-17
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
16571-657-10Cevimeline Hydrochloride100 in 1 BOTTLECAPSULE1009

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16571-657-10EA - Each16571-65727a9705e-ca3f-48b2-943d-bfdf4463eea012014-07-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Cevimeline HydrochlorideACTIVE INGREDIENTP81Q6V85NPCEVIMELINE HYDROCHLORIDE CAPSULE [PACK PHARMACEUTICALS, LLC]4
CEVIMELINEACTIVE MOIETYK9V0CDQ56ECEVIMELINE HYDROCHLORIDE CAPSULE [PACK PHARMACEUTICALS, LLC]4
hydroxypropyl celluloseINACTIVE INGREDIENTRFW2ET671PCEVIMELINE HYDROCHLORIDE CAPSULE [PACK PHARMACEUTICALS, LLC]4
lactose monohydrateINACTIVE INGREDIENTEWQ57Q8I5XCEVIMELINE HYDROCHLORIDE CAPSULE [PACK PHARMACEUTICALS, LLC]4
magnesium stearateINACTIVE INGREDIENT70097M6I30CEVIMELINE HYDROCHLORIDE CAPSULE [PACK PHARMACEUTICALS, LLC]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16571-657CEVIMELINE HYDROCHLORIDE CAPSULE [RISING PHARMA HOLDINGS, INC.]9Current NDC, Legacy NDC, 1 package rows20240809_d4bd942a-1339-40c5-8fd4-850da5a69635.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309140cevimeline HCl 30 MG Oral CapsulePSN51307f82-66f2-41c7-80ff-174d7e50f7ee101
309140cevimeline hydrochloride 30 MG Oral CapsuleSCD51307f82-66f2-41c7-80ff-174d7e50f7ee101
309140cevimeline HCl 30 MG Oral CapsulePSNd4bd942a-1339-40c5-8fd4-850da5a696359
309140cevimeline hydrochloride 30 MG Oral CapsuleSCDd4bd942a-1339-40c5-8fd4-850da5a696359
309140cevimeline HCl 30 MG Oral CapsulePSNbcaaec18-4ee1-4cfd-84da-8fe3b8c54fc41
309140cevimeline hydrochloride 30 MG Oral CapsuleSCDbcaaec18-4ee1-4cfd-84da-8fe3b8c54fc41

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
16571-657-1016571065710100 CAPSULE in 1 BOTTLE (16571-657-10) 100 capsule2014-06-170000-00-00NoNoCurrent