FDA.reportPublic FDA data

cevimeline hydrochloride

Product NDC
43386-999
11-digit product format
433860999
Labeler code
43386
Product ID
43386-999_7e108db5-5292-4f2e-9d10-e15319503898
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
cevimeline hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Lupin Pharmaceuticals,Inc.
Application
ANDA204746
Marketing category
ANDA
Marketing start
2016-12-30
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
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43386-999-01cevimeline hydrochloride100 in 1 BOTTLECAPSULE1002
43386-999-03cevimeline hydrochloride30 in 1 BOTTLECAPSULE302
43386-999-05cevimeline hydrochloride500 in 1 BOTTLECAPSULE5002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43386-999-01EA - Each43386-99951c3ed88-54e0-4d11-b0bd-31fae2191f2c12020-01-03

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43386-999CEVIMELINE HYDROCHLORIDE CAPSULE [LUPIN PHARMACEUTICALS,INC.]2Current NDC, Legacy NDC, 3 package rows20240201_0fbcf1a7-5b8b-42fb-b764-4b529e7d1a99.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309140cevimeline HCl 30 MG Oral CapsulePSN0fbcf1a7-5b8b-42fb-b764-4b529e7d1a992
309140cevimeline hydrochloride 30 MG Oral CapsuleSCD0fbcf1a7-5b8b-42fb-b764-4b529e7d1a992

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43386-999-0143386099901100 CAPSULE in 1 BOTTLE (43386-999-01) 100 capsule2016-12-300000-00-00NoNoCurrent
43386-999-034338609990330 CAPSULE in 1 BOTTLE (43386-999-03) 30 capsule2016-12-300000-00-00NoNoCurrent
43386-999-0543386099905500 CAPSULE in 1 BOTTLE (43386-999-05) 500 capsule2016-12-300000-00-00NoNoCurrent