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
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A207681-001 | DARIFENACIN HYDROBROMIDE | DARIFENACIN HYDROBROMIDE | EQ 7.5MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-12-08 | |
| A207681-002 | DARIFENACIN HYDROBROMIDE | DARIFENACIN HYDROBROMIDE | EQ 15MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-12-08 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A207681-001 | AB |
| A207681-002 | AB |
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.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A207681-001 | DARIFENACIN HYDROBROMIDE | EQ 7.5MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-12-08 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A207681-002 | DARIFENACIN HYDROBROMIDE | EQ 15MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-12-08 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A207681-001 | DARIFENACIN HYDROBROMIDE | EQ 7.5MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-12-08 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A207681-002 | DARIFENACIN HYDROBROMIDE | EQ 15MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-12-08 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A207681-001 | DARIFENACIN HYDROBROMIDE | EQ 7.5MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-12-08 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A207681-002 | DARIFENACIN HYDROBROMIDE | EQ 15MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-12-08 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A207681-001 | DARIFENACIN HYDROBROMIDE | EQ 7.5MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-12-08 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A207681-002 | DARIFENACIN HYDROBROMIDE | EQ 15MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-12-08 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A207681-001 | DARIFENACIN HYDROBROMIDE | EQ 7.5MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-12-08 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A207681-002 | DARIFENACIN HYDROBROMIDE | EQ 15MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-12-08 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A207681-001 | DARIFENACIN HYDROBROMIDE | EQ 7.5MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-12-08 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A207681-002 | DARIFENACIN HYDROBROMIDE | EQ 15MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-12-08 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A207681-001 | DARIFENACIN HYDROBROMIDE | EQ 7.5MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-12-08 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A207681-002 | DARIFENACIN HYDROBROMIDE | EQ 15MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-12-08 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A207681-001 | DARIFENACIN HYDROBROMIDE | EQ 7.5MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-12-08 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A207681-002 | DARIFENACIN HYDROBROMIDE | EQ 15MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-12-08 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A207681-001 | DARIFENACIN HYDROBROMIDE | EQ 7.5MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-12-08 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A207681-002 | DARIFENACIN HYDROBROMIDE | EQ 15MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-12-08 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A207681-001 | DARIFENACIN HYDROBROMIDE | EQ 7.5MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-12-08 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A207681-002 | DARIFENACIN HYDROBROMIDE | EQ 15MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-12-08 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A207681-001 | DARIFENACIN HYDROBROMIDE | EQ 7.5MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-12-08 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A207681-002 | DARIFENACIN HYDROBROMIDE | EQ 15MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-12-08 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A207681-001 | DARIFENACIN HYDROBROMIDE | EQ 7.5MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-12-08 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A207681-002 | DARIFENACIN HYDROBROMIDE | EQ 15MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-12-08 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A207681-001 | DARIFENACIN HYDROBROMIDE | EQ 7.5MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-12-08 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A207681-002 | DARIFENACIN HYDROBROMIDE | EQ 15MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-12-08 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A207681-001 | DARIFENACIN HYDROBROMIDE | EQ 7.5MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-12-08 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A207681-002 | DARIFENACIN HYDROBROMIDE | EQ 15MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-12-08 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A207681-001 | DARIFENACIN HYDROBROMIDE | EQ 7.5MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-12-08 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | A207681-002 | DARIFENACIN HYDROBROMIDE | EQ 15MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-12-08 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A207681-001 | DARIFENACIN HYDROBROMIDE | EQ 7.5MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-12-08 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A207681-002 | DARIFENACIN HYDROBROMIDE | EQ 15MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-12-08 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A207681-001 | DARIFENACIN HYDROBROMIDE | EQ 7.5MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-12-08 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | A207681-002 | DARIFENACIN HYDROBROMIDE | EQ 15MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-12-08 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A207681-001 | DARIFENACIN HYDROBROMIDE | EQ 7.5MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-12-08 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | A207681-002 | DARIFENACIN HYDROBROMIDE | EQ 15MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-12-08 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A207681-001 | DARIFENACIN HYDROBROMIDE | EQ 7.5MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-12-08 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | A207681-002 | DARIFENACIN HYDROBROMIDE | EQ 15MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-12-08 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A207681-001 | DARIFENACIN HYDROBROMIDE | EQ 7.5MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-12-08 | bb7c543d1eb4… | |
| 2022-03-09 01:35 UTC | 2022-03 | A207681-002 | DARIFENACIN HYDROBROMIDE | EQ 15MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-12-08 | bb7c543d1eb4… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A207681-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A207681-002 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A207681-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A207681-002 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A207681-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A207681-002 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A207681-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A207681-002 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A207681-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A207681-002 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A207681-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A207681-002 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A207681-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A207681-002 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A207681-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A207681-002 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A207681-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A207681-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A207681-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A207681-002 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A207681-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A207681-002 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A207681-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A207681-002 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A207681-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A207681-002 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A207681-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A207681-002 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A207681-001 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A207681-002 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A207681-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A207681-002 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A207681-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A207681-002 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A207681-001 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A207681-002 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A207681-001 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A207681-002 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A207681-001 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A207681-002 | AB | 1 | bb7c543d1eb4… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- DARIFENACIN
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| DARIFENACIN HYDROBROMIDE | 7.5 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| CR02EYQ8GV | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| da7c2732-232c-4e71-92d9-577ef8617f56 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| a92d88f6-1aad-c4c8-f6bc-f9f74c3d7bb2 | Product name | 7 | 20200407 |
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 46708-223-08 | DARIFENACIN | 08 in 1 BLISTER PACK | TABLET, EXTENDED RELEASE | 08 | 3 | |
| 46708-223-30 | DARIFENACIN | 30 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 30 | 3 | |
| 46708-223-90 | DARIFENACIN | 90 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 90 | 3 | |
| 46708-223-91 | DARIFENACIN | 1000 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 1000 | 3 |
DailyMed Dashboard NDC Coverage#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| DARIFENACIN | DARIFENACIN | Alembic Pharmaceuticals Limited | da7c2732-232c-4e71-92d9-577ef8617f56 | 2023-01-30 | Warnings, Adverse reactions | 207681 ANDA207681 46708-223 |
| DARIFENACIN | DARIFENACIN | Alembic Pharmaceuticals Inc. | 9f6952c8-e547-4f3e-a978-a88d6ea9dc10 | 2021-12-13 | Warnings, Adverse reactions | 207681 ANDA207681 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 485421 | darifenacin 15 MG 24HR Extended Release Oral Tablet | PSN | da7c2732-232c-4e71-92d9-577ef8617f56 | 3 |
| 485423 | darifenacin 7.5 MG 24HR Extended Release Oral Tablet | PSN | da7c2732-232c-4e71-92d9-577ef8617f56 | 3 |
| 485421 | 24 HR darifenacin 15 MG Extended Release Oral Tablet | SCD | da7c2732-232c-4e71-92d9-577ef8617f56 | 3 |
| 485423 | 24 HR darifenacin 7.5 MG Extended Release Oral Tablet | SCD | da7c2732-232c-4e71-92d9-577ef8617f56 | 3 |
| 485421 | darifenacin 15 MG (as darifenacin HBr 17.846 MG) 24 HR Extended Release Oral Tablet | SY | da7c2732-232c-4e71-92d9-577ef8617f56 | 3 |
| 485423 | darifenacin 7.5 MG (as darifenacin HBr 8.923 MG) 24 HR Extended Release Oral Tablet | SY | da7c2732-232c-4e71-92d9-577ef8617f56 | 3 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 46708-223-08 | 46708022308 | 8 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (46708-223-08) | 2017-12-12 | 0000-00-00 | No | No | Current |
| 46708-223-30 | 46708022330 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (46708-223-30) | 2017-12-12 | 0000-00-00 | No | No | Current |
| 46708-223-90 | 46708022390 | 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (46708-223-90) | 2017-12-12 | 0000-00-00 | No | No | Current |
| 46708-223-91 | 46708022391 | 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (46708-223-91) | 2017-12-12 | 0000-00-00 | No | No | Current |