FDA.reportPublic FDA data

CEVIMELINE HYDROCHLORIDE

Product NDC
72789-457
11-digit product format
727890457
Labeler code
72789
Product ID
72789-457_48d8a76e-8103-9485-e063-6294a90af9ab
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CEVIMELINE HYDROCHLORIDE
Dosage form
CAPSULE
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA216682
Marketing category
ANDA
Marketing start
2023-04-06
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
72789-457-01CEVIMELINE HYDROCHLORIDE100 in 1 BOTTLE, PLASTICCAPSULE1004
72789-457-30CEVIMELINE HYDROCHLORIDE30 in 1 BOTTLE, PLASTICCAPSULE304

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72789-457-01EA - Each72789-457e74f0641-4b8c-4574-b719-f4070ebf98a212025-02-10
72789-457-30EA - Each72789-4575df0187c-8070-4ae4-853f-354497d4d23e12025-02-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72789-457CEVIMELINE HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.]2Current NDC, 2 package rows20250101_2b429ea7-1c7c-47a4-803c-2546736f5c36.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309140cevimeline HCl 30 MG Oral CapsulePSN2b429ea7-1c7c-47a4-803c-2546736f5c364
309140cevimeline hydrochloride 30 MG Oral CapsuleSCD2b429ea7-1c7c-47a4-803c-2546736f5c364

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72789-457-0172789045701100 CAPSULE in 1 BOTTLE, PLASTIC (72789-457-01) 100 capsule2024-12-30NoNoCurrent
72789-457-307278904573030 CAPSULE in 1 BOTTLE, PLASTIC (72789-457-30) 30 capsule2024-12-30NoNoCurrent