FDA.reportPublic FDA data

Cevimeline Hydrochloride

Product NDC
87063-180
11-digit product format
870630180
Labeler code
87063
Product ID
87063-180_52122958-4ecb-02ec-e063-6394a90a47d5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cevimeline Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
ASCLEMED USA 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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Cevimeline Hydrochloride
Listing expiration
2027-12-31

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
87063-180-01Cevimeline Hydrochloride100 in 1 BOTTLECAPSULE1001
87063-180-30Cevimeline Hydrochloride30 in 1 BOTTLECAPSULE301
87063-180-60Cevimeline Hydrochloride60 in 1 BOTTLECAPSULE601
87063-180-90Cevimeline Hydrochloride90 in 1 BOTTLECAPSULE901

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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 startSampleExclude flagStatus
87063-180-0187063018001100 CAPSULE in 1 BOTTLE (87063-180-01) 100 capsule2026-05-18NoNoHistorical
87063-180-308706301803030 CAPSULE in 1 BOTTLE (87063-180-30) 30 capsule2026-05-18NoNoHistorical
87063-180-608706301806060 CAPSULE in 1 BOTTLE (87063-180-60) 60 capsule2026-05-18NoNoHistorical
87063-180-908706301809090 CAPSULE in 1 BOTTLE (87063-180-90) 90 capsule2026-05-18NoNoHistorical