DARIFENACIN

Product NDC
46708-223
11-digit product format
467080223
Labeler code
46708
Product ID
46708-223_70d8a245-0125-4c31-b941-2137d96c43c3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DARIFENACIN
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Alembic Pharmaceuticals Limited
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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A207681-001DARIFENACIN HYDROBROMIDEDARIFENACIN HYDROBROMIDEEQ 7.5MG BASETABLET, EXTENDED RELEASE / ORALAB2017-12-08
A207681-002DARIFENACIN HYDROBROMIDEDARIFENACIN HYDROBROMIDEEQ 15MG BASETABLET, EXTENDED RELEASE / ORALAB2017-12-08

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A207681-001AB
A207681-002AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A207681-001DARIFENACIN HYDROBROMIDEEQ 7.5MG BASETABLET, EXTENDED RELEASE / ORALAB2017-12-08caaa826d4ba7…
2026-08-18 06:07:402026-07A207681-002DARIFENACIN HYDROBROMIDEEQ 15MG BASETABLET, EXTENDED RELEASE / ORALAB2017-12-08caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A207681-001DARIFENACIN HYDROBROMIDEEQ 7.5MG BASETABLET, EXTENDED RELEASE / ORALAB2017-12-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207681-002DARIFENACIN HYDROBROMIDEEQ 15MG BASETABLET, EXTENDED RELEASE / ORALAB2017-12-08011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207681-001DARIFENACIN HYDROBROMIDEEQ 7.5MG BASETABLET, EXTENDED RELEASE / ORALAB2017-12-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207681-002DARIFENACIN HYDROBROMIDEEQ 15MG BASETABLET, EXTENDED RELEASE / ORALAB2017-12-0831067a03dcf5…
2025-08-23 18:47 UTC2025-08A207681-001DARIFENACIN HYDROBROMIDEEQ 7.5MG BASETABLET, EXTENDED RELEASE / ORALAB2017-12-086a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207681-002DARIFENACIN HYDROBROMIDEEQ 15MG BASETABLET, EXTENDED RELEASE / ORALAB2017-12-086a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207681-001DARIFENACIN HYDROBROMIDEEQ 7.5MG BASETABLET, EXTENDED RELEASE / ORALAB2017-12-08fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207681-002DARIFENACIN HYDROBROMIDEEQ 15MG BASETABLET, EXTENDED RELEASE / ORALAB2017-12-08fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207681-001DARIFENACIN HYDROBROMIDEEQ 7.5MG BASETABLET, EXTENDED RELEASE / ORALAB2017-12-08b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207681-002DARIFENACIN HYDROBROMIDEEQ 15MG BASETABLET, EXTENDED RELEASE / ORALAB2017-12-08b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207681-001DARIFENACIN HYDROBROMIDEEQ 7.5MG BASETABLET, EXTENDED RELEASE / ORALAB2017-12-0803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207681-002DARIFENACIN HYDROBROMIDEEQ 15MG BASETABLET, EXTENDED RELEASE / ORALAB2017-12-0803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207681-001DARIFENACIN HYDROBROMIDEEQ 7.5MG BASETABLET, EXTENDED RELEASE / ORALAB2017-12-082680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207681-002DARIFENACIN HYDROBROMIDEEQ 15MG BASETABLET, EXTENDED RELEASE / ORALAB2017-12-082680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207681-001DARIFENACIN HYDROBROMIDEEQ 7.5MG BASETABLET, EXTENDED RELEASE / ORALAB2017-12-085bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207681-002DARIFENACIN HYDROBROMIDEEQ 15MG BASETABLET, EXTENDED RELEASE / ORALAB2017-12-085bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207681-001DARIFENACIN HYDROBROMIDEEQ 7.5MG BASETABLET, EXTENDED RELEASE / ORALAB2017-12-08d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207681-002DARIFENACIN HYDROBROMIDEEQ 15MG BASETABLET, EXTENDED RELEASE / ORALAB2017-12-08d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A207681-001DARIFENACIN HYDROBROMIDEEQ 7.5MG BASETABLET, EXTENDED RELEASE / ORALAB2017-12-08d06236e962d9…
2024-10-29 15:01 UTC2024-10A207681-002DARIFENACIN HYDROBROMIDEEQ 15MG BASETABLET, EXTENDED RELEASE / ORALAB2017-12-08d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207681-001DARIFENACIN HYDROBROMIDEEQ 7.5MG BASETABLET, EXTENDED RELEASE / ORALAB2017-12-0879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207681-002DARIFENACIN HYDROBROMIDEEQ 15MG BASETABLET, EXTENDED RELEASE / ORALAB2017-12-0879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207681-001DARIFENACIN HYDROBROMIDEEQ 7.5MG BASETABLET, EXTENDED RELEASE / ORALAB2017-12-08301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207681-002DARIFENACIN HYDROBROMIDEEQ 15MG BASETABLET, EXTENDED RELEASE / ORALAB2017-12-08301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207681-001DARIFENACIN HYDROBROMIDEEQ 7.5MG BASETABLET, EXTENDED RELEASE / ORALAB2017-12-081e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207681-002DARIFENACIN HYDROBROMIDEEQ 15MG BASETABLET, EXTENDED RELEASE / ORALAB2017-12-081e350fbaab3a…
2024-05-31 18:47 UTC2024-05A207681-001DARIFENACIN HYDROBROMIDEEQ 7.5MG BASETABLET, EXTENDED RELEASE / ORALAB2017-12-088072bd15b7f6…
2024-05-31 18:47 UTC2024-05A207681-002DARIFENACIN HYDROBROMIDEEQ 15MG BASETABLET, EXTENDED RELEASE / ORALAB2017-12-088072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A207681-001DARIFENACIN HYDROBROMIDEEQ 7.5MG BASETABLET, EXTENDED RELEASE / ORALAB2017-12-085c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A207681-002DARIFENACIN HYDROBROMIDEEQ 15MG BASETABLET, EXTENDED RELEASE / ORALAB2017-12-085c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A207681-001DARIFENACIN HYDROBROMIDEEQ 7.5MG BASETABLET, EXTENDED RELEASE / ORALAB2017-12-085d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A207681-002DARIFENACIN HYDROBROMIDEEQ 15MG BASETABLET, EXTENDED RELEASE / ORALAB2017-12-085d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A207681-001DARIFENACIN HYDROBROMIDEEQ 7.5MG BASETABLET, EXTENDED RELEASE / ORALAB2017-12-084b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A207681-002DARIFENACIN HYDROBROMIDEEQ 15MG BASETABLET, EXTENDED RELEASE / ORALAB2017-12-084b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A207681-001DARIFENACIN HYDROBROMIDEEQ 7.5MG BASETABLET, EXTENDED RELEASE / ORALAB2017-12-0874a2ff9319b5…
2019-12-13 00:20 UTC2019-12A207681-002DARIFENACIN HYDROBROMIDEEQ 15MG BASETABLET, EXTENDED RELEASE / ORALAB2017-12-0874a2ff9319b5…
2022-03-09 01:35 UTC2022-03A207681-001DARIFENACIN HYDROBROMIDEEQ 7.5MG BASETABLET, EXTENDED RELEASE / ORALAB2017-12-08bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A207681-002DARIFENACIN HYDROBROMIDEEQ 15MG BASETABLET, EXTENDED RELEASE / ORALAB2017-12-08bb7c543d1eb4…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A207681-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A207681-002AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A207681-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207681-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207681-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207681-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A207681-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207681-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207681-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207681-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207681-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207681-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207681-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207681-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207681-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207681-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207681-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207681-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207681-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207681-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A207681-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A207681-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207681-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207681-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207681-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207681-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207681-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207681-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A207681-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A207681-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A207681-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A207681-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A207681-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A207681-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A207681-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A207681-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A207681-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A207681-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A207681-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A207681-002AB1bb7c543d1eb4…

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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
CR02EYQ8GVInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
485421Internal RxNorm lookup
485423Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
da7c2732-232c-4e71-92d9-577ef8617f56Available on FDA.report

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
46708-223-082023-02-01These highlights do not include all the information needed to use DARIFENACIN EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for DARIFENACIN EXTENDED-RELEASE TABLETS. DARIFENACIN extended-release tablets, for oral use Initial U.S. Approval: 2004
46708-223-302023-02-01These highlights do not include all the information needed to use DARIFENACIN EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for DARIFENACIN EXTENDED-RELEASE TABLETS. DARIFENACIN extended-release tablets, for oral use Initial U.S. Approval: 2004
46708-223-902023-02-01These highlights do not include all the information needed to use DARIFENACIN EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for DARIFENACIN EXTENDED-RELEASE TABLETS. DARIFENACIN extended-release tablets, for oral use Initial U.S. Approval: 2004
46708-223-912023-02-01These highlights do not include all the information needed to use DARIFENACIN EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for DARIFENACIN EXTENDED-RELEASE TABLETS. DARIFENACIN extended-release tablets, for oral use Initial U.S. Approval: 2004
46708-223-082023-01-30These highlights do not include all the information needed to use DARIFENACIN EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for DARIFENACIN EXTENDED-RELEASE TABLETS. DARIFENACIN extended-release tablets, for oral use Initial U.S. Approval: 2004
46708-223-302023-01-30These highlights do not include all the information needed to use DARIFENACIN EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for DARIFENACIN EXTENDED-RELEASE TABLETS. DARIFENACIN extended-release tablets, for oral use Initial U.S. Approval: 2004
46708-223-902023-01-30These highlights do not include all the information needed to use DARIFENACIN EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for DARIFENACIN EXTENDED-RELEASE TABLETS. DARIFENACIN extended-release tablets, for oral use Initial U.S. Approval: 2004
46708-223-912023-01-30These highlights do not include all the information needed to use DARIFENACIN EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for DARIFENACIN EXTENDED-RELEASE TABLETS. DARIFENACIN extended-release tablets, for oral use Initial U.S. Approval: 2004

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
46708-223-08DARIFENACIN08 in 1 BLISTER PACKTABLET, EXTENDED RELEASE083
46708-223-30DARIFENACIN30 in 1 BOTTLETABLET, EXTENDED RELEASE303
46708-223-90DARIFENACIN90 in 1 BOTTLETABLET, EXTENDED RELEASE903
46708-223-91DARIFENACIN1000 in 1 BOTTLETABLET, EXTENDED RELEASE10003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
46708-223DARIFENACIN TABLET, EXTENDED RELEASE [ALEMBIC PHARMACEUTICALS LIMITED]3Current NDC, Legacy NDC, 4 package rows20230202_da7c2732-232c-4e71-92d9-577ef8617f56.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DARIFENACINDARIFENACINAlembic Pharmaceuticals Limitedda7c2732-232c-4e71-92d9-577ef8617f562023-01-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207681
application number: ANDA207681
ndc (product): 46708-223
DARIFENACINDARIFENACINAlembic Pharmaceuticals Inc.9f6952c8-e547-4f3e-a978-a88d6ea9dc102021-12-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207681
application number: ANDA207681

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
485421darifenacin 15 MG 24HR Extended Release Oral TabletPSNda7c2732-232c-4e71-92d9-577ef8617f563
485423darifenacin 7.5 MG 24HR Extended Release Oral TabletPSNda7c2732-232c-4e71-92d9-577ef8617f563
48542124 HR darifenacin 15 MG Extended Release Oral TabletSCDda7c2732-232c-4e71-92d9-577ef8617f563
48542324 HR darifenacin 7.5 MG Extended Release Oral TabletSCDda7c2732-232c-4e71-92d9-577ef8617f563
485421darifenacin 15 MG (as darifenacin HBr 17.846 MG) 24 HR Extended Release Oral TabletSYda7c2732-232c-4e71-92d9-577ef8617f563
485423darifenacin 7.5 MG (as darifenacin HBr 8.923 MG) 24 HR Extended Release Oral TabletSYda7c2732-232c-4e71-92d9-577ef8617f563

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
46708-223-08467080223088 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (46708-223-08) 2017-12-120000-00-00NoNoCurrent
46708-223-304670802233030 TABLET, EXTENDED RELEASE in 1 BOTTLE (46708-223-30) 2017-12-120000-00-00NoNoCurrent
46708-223-904670802239090 TABLET, EXTENDED RELEASE in 1 BOTTLE (46708-223-90) 2017-12-120000-00-00NoNoCurrent
46708-223-91467080223911000 TABLET, EXTENDED RELEASE in 1 BOTTLE (46708-223-91) 2017-12-120000-00-00NoNoCurrent