FDA.reportPublic FDA data

DARIFENACIN

Product NDC
62332-223
11-digit product format
623320223
Labeler code
62332
Product ID
62332-223_0f406336-e614-4427-89c7-bd26d3792590
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DARIFENACIN
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Alembic Pharmaceuticals Inc.
Application
ANDA207681
Marketing category
ANDA
Marketing start
2017-12-12
Substance
DARIFENACIN HYDROBROMIDE
Active strength
7.5 mg/1
Pharmacologic classes
Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
DARIFENACIN
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DARIFENACIN HYDROBROMIDE7.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiCR02EYQ8GV
Rxcui485421, 485423

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a92d88f6-1aad-c4c8-f6bc-f9f74c3d7bb2Product name720200407

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62332-223-08DARIFENACIN08 in 1 BLISTER PACKTABLET, EXTENDED RELEASE088
62332-223-30DARIFENACIN30 in 1 BOTTLETABLET, EXTENDED RELEASE308
62332-223-90DARIFENACIN90 in 1 BOTTLETABLET, EXTENDED RELEASE908
62332-223-91DARIFENACIN1000 in 1 BOTTLETABLET, EXTENDED RELEASE10008

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62332-223-30EA - Each62332-2230fbda9af-a638-4dc7-9c09-0effd0886d4212024-02-14
62332-223-90EA - Each62332-2236bcb8ef7-ace4-4b78-869a-a67168eae31412024-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62332-223DARIFENACIN TABLET, EXTENDED RELEASE [ALEMBIC PHARMACEUTICALS INC.]8Current NDC, Legacy NDC, 4 package rows20220112_9f6952c8-e547-4f3e-a978-a88d6ea9dc10.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
485421darifenacin 15 MG 24HR Extended Release Oral TabletPSN9f6952c8-e547-4f3e-a978-a88d6ea9dc108
485423darifenacin 7.5 MG 24HR Extended Release Oral TabletPSN9f6952c8-e547-4f3e-a978-a88d6ea9dc108
48542124 HR darifenacin 15 MG Extended Release Oral TabletSCD9f6952c8-e547-4f3e-a978-a88d6ea9dc108
48542324 HR darifenacin 7.5 MG Extended Release Oral TabletSCD9f6952c8-e547-4f3e-a978-a88d6ea9dc108
485421darifenacin 15 MG (as darifenacin HBr 17.846 MG) 24 HR Extended Release Oral TabletSY9f6952c8-e547-4f3e-a978-a88d6ea9dc108
485423darifenacin 7.5 MG (as darifenacin HBr 8.923 MG) 24 HR Extended Release Oral TabletSY9f6952c8-e547-4f3e-a978-a88d6ea9dc108

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
62332-223-08623320223088 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (62332-223-08) 2017-12-120000-00-00NoNoCurrent
62332-223-306233202233030 TABLET, EXTENDED RELEASE in 1 BOTTLE (62332-223-30) 2017-12-120000-00-00NoNoCurrent
62332-223-906233202239090 TABLET, EXTENDED RELEASE in 1 BOTTLE (62332-223-90) 2017-12-120000-00-00NoNoCurrent
62332-223-91623320223911000 TABLET, EXTENDED RELEASE in 1 BOTTLE (62332-223-91) 2017-12-120000-00-00NoNoCurrent