FDA.reportPublic FDA data

Cevimeline Hydrochloride

Product NDC
63629-9863
11-digit product format
636299863
Labeler code
63629
Product ID
63629-9863_b8a8d949-15e3-4dc7-afd2-c9621a5c7c83
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cevimeline Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
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
63629-9863-1Cevimeline Hydrochloride30 in 1 BOTTLECAPSULE30101
63629-9863-2Cevimeline Hydrochloride60 in 1 BOTTLECAPSULE60101
63629-9863-3Cevimeline Hydrochloride90 in 1 BOTTLECAPSULE90101

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-9863-1EA - Each63629-9863dc6efff2-3a08-4114-abf8-c6aba17ff3aa12025-08-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-9863CEVIMELINE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]101Current NDC, 3 package rows20240913_51307f82-66f2-41c7-80ff-174d7e50f7ee.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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
63629-9863-16362998630130 CAPSULE in 1 BOTTLE (63629-9863-1) 30 capsule2023-11-30NoNoHistorical
63629-9863-26362998630260 CAPSULE in 1 BOTTLE (63629-9863-2) 60 capsule2024-09-05NoNoHistorical
63629-9863-36362998630390 CAPSULE in 1 BOTTLE (63629-9863-3) 90 capsule2024-09-05NoNoHistorical