Application 040677
- Type
- ANDA
- Sponsor
- LANNETT CO INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | BETHANECHOL CHLORIDE | BETHANECHOL CHLORIDE | TABLET;ORAL | 50MG | No | No |
| 002 | BETHANECHOL CHLORIDE | BETHANECHOL CHLORIDE | TABLET;ORAL | 5MG | No | No |
| 003 | BETHANECHOL CHLORIDE | BETHANECHOL CHLORIDE | TABLET;ORAL | 10MG | No | No |
| 004 | BETHANECHOL CHLORIDE | BETHANECHOL CHLORIDE | TABLET;ORAL | 25MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A040677-001 | BETHANECHOL CHLORIDE | BETHANECHOL CHLORIDE | 50MG | TABLET / ORAL | 2008-03-27 | ||
| A040677-002 | BETHANECHOL CHLORIDE | BETHANECHOL CHLORIDE | 5MG | TABLET / ORAL | 2008-03-27 | ||
| A040677-003 | BETHANECHOL CHLORIDE | BETHANECHOL CHLORIDE | 10MG | TABLET / ORAL | 2008-03-27 | ||
| A040677-004 | BETHANECHOL CHLORIDE | BETHANECHOL CHLORIDE | 25MG | TABLET / ORAL | 2008-03-27 |
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 | A040677-001 | BETHANECHOL CHLORIDE | 50MG | TABLET / ORAL | 2008-03-27 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A040677-002 | BETHANECHOL CHLORIDE | 5MG | TABLET / ORAL | 2008-03-27 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A040677-003 | BETHANECHOL CHLORIDE | 10MG | TABLET / ORAL | 2008-03-27 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A040677-004 | BETHANECHOL CHLORIDE | 25MG | TABLET / ORAL | 2008-03-27 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A040677-001 | BETHANECHOL CHLORIDE | 50MG | TABLET / ORAL | 2008-03-27 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A040677-002 | BETHANECHOL CHLORIDE | 5MG | TABLET / ORAL | 2008-03-27 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A040677-003 | BETHANECHOL CHLORIDE | 10MG | TABLET / ORAL | 2008-03-27 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A040677-004 | BETHANECHOL CHLORIDE | 25MG | TABLET / ORAL | 2008-03-27 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040677-001 | BETHANECHOL CHLORIDE | 50MG | TABLET / ORAL | 2008-03-27 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040677-002 | BETHANECHOL CHLORIDE | 5MG | TABLET / ORAL | 2008-03-27 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040677-003 | BETHANECHOL CHLORIDE | 10MG | TABLET / ORAL | 2008-03-27 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040677-004 | BETHANECHOL CHLORIDE | 25MG | TABLET / ORAL | 2008-03-27 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A040677-001 | BETHANECHOL CHLORIDE | 50MG | TABLET / ORAL | 2008-03-27 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A040677-002 | BETHANECHOL CHLORIDE | 5MG | TABLET / ORAL | 2008-03-27 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A040677-003 | BETHANECHOL CHLORIDE | 10MG | TABLET / ORAL | 2008-03-27 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A040677-004 | BETHANECHOL CHLORIDE | 25MG | TABLET / ORAL | 2008-03-27 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040677-001 | BETHANECHOL CHLORIDE | 50MG | TABLET / ORAL | 2008-03-27 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040677-002 | BETHANECHOL CHLORIDE | 5MG | TABLET / ORAL | 2008-03-27 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040677-003 | BETHANECHOL CHLORIDE | 10MG | TABLET / ORAL | 2008-03-27 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040677-004 | BETHANECHOL CHLORIDE | 25MG | TABLET / ORAL | 2008-03-27 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040677-001 | BETHANECHOL CHLORIDE | 50MG | TABLET / ORAL | 2008-03-27 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040677-002 | BETHANECHOL CHLORIDE | 5MG | TABLET / ORAL | 2008-03-27 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040677-003 | BETHANECHOL CHLORIDE | 10MG | TABLET / ORAL | 2008-03-27 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040677-004 | BETHANECHOL CHLORIDE | 25MG | TABLET / ORAL | 2008-03-27 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040677-001 | BETHANECHOL CHLORIDE | 50MG | TABLET / ORAL | 2008-03-27 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040677-002 | BETHANECHOL CHLORIDE | 5MG | TABLET / ORAL | 2008-03-27 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040677-003 | BETHANECHOL CHLORIDE | 10MG | TABLET / ORAL | 2008-03-27 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040677-004 | BETHANECHOL CHLORIDE | 25MG | TABLET / ORAL | 2008-03-27 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040677-001 | BETHANECHOL CHLORIDE | 50MG | TABLET / ORAL | 2008-03-27 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040677-002 | BETHANECHOL CHLORIDE | 5MG | TABLET / ORAL | 2008-03-27 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040677-003 | BETHANECHOL CHLORIDE | 10MG | TABLET / ORAL | 2008-03-27 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040677-004 | BETHANECHOL CHLORIDE | 25MG | TABLET / ORAL | 2008-03-27 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040677-001 | BETHANECHOL CHLORIDE | 50MG | TABLET / ORAL | 2008-03-27 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040677-002 | BETHANECHOL CHLORIDE | 5MG | TABLET / ORAL | 2008-03-27 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040677-003 | BETHANECHOL CHLORIDE | 10MG | TABLET / ORAL | 2008-03-27 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040677-004 | BETHANECHOL CHLORIDE | 25MG | TABLET / ORAL | 2008-03-27 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A040677-001 | BETHANECHOL CHLORIDE | 50MG | TABLET / ORAL | 2008-03-27 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A040677-002 | BETHANECHOL CHLORIDE | 5MG | TABLET / ORAL | 2008-03-27 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A040677-003 | BETHANECHOL CHLORIDE | 10MG | TABLET / ORAL | 2008-03-27 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A040677-004 | BETHANECHOL CHLORIDE | 25MG | TABLET / ORAL | 2008-03-27 | d8e5a09893c0… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A040677-001 | AA | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A040677-002 | AA | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A040677-003 | AA | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A040677-004 | AA | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A040677-001 | AA | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A040677-002 | AA | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A040677-003 | AA | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A040677-004 | AA | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A040677-001 | AA | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A040677-002 | AA | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A040677-003 | AA | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A040677-004 | AA | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A040677-001 | AA | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A040677-002 | AA | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A040677-003 | AA | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A040677-004 | AA | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A040677-001 | AA | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A040677-002 | AA | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A040677-003 | AA | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A040677-004 | AA | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A040677-001 | AA | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A040677-002 | AA | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A040677-003 | AA | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A040677-004 | AA | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A040677-001 | AA | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A040677-002 | AA | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A040677-003 | AA | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A040677-004 | AA | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A040677-001 | AA | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | A040677-002 | AA | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | A040677-003 | AA | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | A040677-004 | AA | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A040677-001 | AA | 1 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | A040677-002 | AA | 1 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | A040677-003 | AA | 1 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | A040677-004 | AA | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A040677-001 | AA | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | A040677-002 | AA | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | A040677-003 | AA | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | A040677-004 | AA | 1 | c0c555d07b60… |
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 |
|---|---|---|---|---|---|---|
| Bethanechol Chloride | BETHANECHOL CHLORIDE | Amneal Pharmaceuticals of New York LLC | 16523451-cd3d-4c10-be06-d59a6f12ac68 | 2026-01-29 | Adverse reactions | Bethanechol Chloride BETHANECHOL CHLORIDE |
| Bethanechol Chloride | BETHANECHOL CHLORIDE | Upsher-Smith Laboratories, LLC | 80393410-dd51-4cac-b27c-50ece00cca37 | 2025-12-16 | Adverse reactions | Bethanechol Chloride BETHANECHOL CHLORIDE |
| Bethanechol Chloride | BETHANECHOL CHLORIDE | Heritage Pharma Labs Inc. d/b/a Avet Pharmaceuticals Labs Inc. | 11ba3d38-a61b-4b03-ba03-4ccf2e450d1f | 2025-10-27 | Adverse reactions | Bethanechol Chloride BETHANECHOL CHLORIDE |
| Bethanechol Chloride | BETHANECHOL CHLORIDE | American Health Packaging | da12a817-9f34-4f26-a7dc-e0e8f9be91c3 | 2024-12-02 | Adverse reactions | Bethanechol Chloride BETHANECHOL CHLORIDE |
| Bethanechol Chloride | BETHANECHOL CHLORIDE | Amneal Pharmaceuticals LLC | 45285692-de51-413e-8a51-7fb792eccc81 | 2024-10-23 | Adverse reactions | Bethanechol Chloride BETHANECHOL CHLORIDE |
| Bethanechol Chloride | BETHANECHOL CHLORIDE | Chartwell RX, LLC | 89267333-ba8b-455b-a8dc-515a888463c2 | 2024-01-22 | Adverse reactions | Bethanechol Chloride BETHANECHOL CHLORIDE |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0527-1329 | Bethanechol Chloride | Bethanechol Chloride | Lannett Company, Inc. | ANDA | Current |
| 0527-1329 | Bethanechol Chloride | Bethanechol Chloride | Lannett Company, Inc. | ANDA | Current |
| 0527-1329 | Bethanechol Chloride | Bethanechol Chloride | Lannett Company, Inc. | ANDA | Current |
| 0527-1329 | Bethanechol Chloride | Bethanechol Chloride | Lannett Company, Inc. | ANDA | Current |
| 0527-1329 | Bethanechol Chloride | Bethanechol Chloride | Lannett Company, Inc. | ANDA | Current |
| 0527-1332 | Bethanechol Chloride | Bethanechol Chloride | Lannett Company, Inc. | ANDA | Current |
| 0527-1332 | Bethanechol Chloride | Bethanechol Chloride | Lannett Company, Inc. | ANDA | Current |
| 0527-1332 | Bethanechol Chloride | Bethanechol Chloride | Lannett Company, Inc. | ANDA | Current |
| 0527-1340 | Bethanechol Chloride | Bethanechol Chloride | Lannett Company, Inc. | ANDA | Current |
| 0527-1340 | Bethanechol Chloride | Bethanechol Chloride | Lannett Company, Inc. | ANDA | Current |
| 0527-1340 | Bethanechol Chloride | Bethanechol Chloride | Lannett Company, Inc. | ANDA | Current |
| 0527-1356 | Bethanechol Chloride | Bethanechol Chloride | Lannett Company, Inc. | ANDA | Current |
| 0527-1356 | Bethanechol Chloride | Bethanechol Chloride | Lannett Company, Inc. | ANDA | Current |
| 0527-1356 | Bethanechol Chloride | Bethanechol Chloride | Lannett Company, Inc. | ANDA | Current |
| 10135-518 | Bethanechol Chloride | Bethanechol Chloride | Marlex Pharmaceuticals Inc | ANDA | Current |