Benztropine Mesylate
- Product NDC
- 64725-2435
- 11-digit product format
- 647252435
- Labeler code
- 64725
- Product ID
- 64725-2435_f3659fef-8fd1-4576-8233-ffaafd41a514
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- benztropine mesylate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- TYA Pharmaceuticals
- Application
- ANDA040715
- Marketing category
- ANDA
- Marketing start
- 2007-08-27
- Marketing end
- 0000-00-00
- Substance
- BENZTROPINE MESYLATE
- Active strength
- 2 mg/1
- Pharmacologic classes
- Anticholinergic [EPC],Antihistamine [EPC],Cholinergic Antagonists [MoA],Histamine Receptor Antagonists [MoA]
- NDC exclude flag
- E
- Listing certified through
- 2017-12-31
- Current FDA listing
- Historical FDA.report record
NDC auxiliary status#
These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded product | product | 64725-2435 | I | Inactivated by FDA | 2026-08-03 | ||
| excluded package | package | 64725-2435 | 64725-2435-1 | I | Inactivated by FDA | 2026-08-03 |
Observed NDC auxiliary status history#
This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
| Captured / source date | Dataset | Scope | Package NDC | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded product | product | d630ba8d3edf… | 732f749b63fb… | |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 64725-2435-1 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded product | product | f5e01cc5f278… | a2eaf40c39c3… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 64725-2435-1 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded product | product | 2ef7874e63bc… | 57b86245f4fa… | |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 64725-2435-1 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded product | product | a1b67e2a42f9… | c4cf2c586c0d… | |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 64725-2435-1 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded product | product | cfe11265f3b6… | 090c488252e2… | |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 64725-2435-1 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded product | product | cdf11ea48f46… | ba0047e9e063… | |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 64725-2435-1 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded product | product | 302b2466d912… | e7b80fea0513… | |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 64725-2435-1 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded product | product | ed331223b511… | 672a5bd82f5f… | |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 64725-2435-1 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded product | product | 0efc9e666f02… | f202fb6c5f17… | |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 64725-2435-1 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded product | product | ad56d346431e… | cc804d4bbf1e… | |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 64725-2435-1 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded product | product | 367a005e9d99… | 383a685ebd0f… | |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 64725-2435-1 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded product | product | 557ba5c1ecfa… | 9c80585c8c6e… | |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 64725-2435-1 | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-05-28 21:12 UTC · source 2024-05-28 | excluded product | product | 8af77b9d5b6f… | d9bbb34c5368… | |
| 2024-05-28 21:12 UTC · source 2024-05-28 | excluded package | package | 64725-2435-1 | 8af77b9d5b6f… | d9bbb34c5368… |
| 2024-05-15 03:39 UTC · source 2024-05-14 | excluded product | product | 834df4deac94… | adcc014656a3… | |
| 2024-05-15 03:39 UTC · source 2024-05-14 | excluded package | package | 64725-2435-1 | 834df4deac94… | adcc014656a3… |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded product | product | 1332a3947898… | d4bfe170f9cd… | |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded package | package | 64725-2435-1 | 1332a3947898… | d4bfe170f9cd… |
| 2022-08-30 03:57 UTC · source 2022-08-29 | excluded product | product | fb8cb913e6d1… | eb8c232b6be0… | |
| 2022-08-30 03:57 UTC · source 2022-08-29 | excluded package | package | 64725-2435-1 | fb8cb913e6d1… | eb8c232b6be0… |
| 2022-04-09 23:13 UTC · source 2022-04-08 | excluded product | product | 86f5da6cb304… | a595104c45d7… | |
| 2022-04-09 23:13 UTC · source 2022-04-08 | excluded package | package | 64725-2435-1 | 86f5da6cb304… | a595104c45d7… |
| 2022-04-04 05:40 UTC · source 2022-04-01 | excluded product | product | bd6a592717d7… | 303034d00443… | |
| 2022-04-04 05:40 UTC · source 2022-04-01 | excluded package | package | 64725-2435-1 | bd6a592717d7… | 303034d00443… |
| 2021-12-27 23:28 UTC · source 2021-12-27 | excluded product | product | 8dfbde2a14a4… | c9ff85d89658… | |
| 2021-12-27 23:28 UTC · source 2021-12-27 | excluded package | package | 64725-2435-1 | 8dfbde2a14a4… | c9ff85d89658… |
| 2020-12-18 03:04 UTC · source 2020-12-17 | excluded product | product | e2bbac7714bc… | 27bdfed8d636… | |
| 2020-12-18 03:04 UTC · source 2020-12-17 | excluded package | package | 64725-2435-1 | e2bbac7714bc… | 27bdfed8d636… |
| 2020-06-10 20:45 UTC · source 2020-06-10 | excluded product | product | 9bebd1f3094a… | 5416666fcb17… | |
| 2020-06-10 20:45 UTC · source 2020-06-10 | excluded package | package | 64725-2435-1 | 9bebd1f3094a… | 5416666fcb17… |
| 2019-12-08 06:16 UTC · source 2019-12-05 | excluded product | product | 110d247fa046… | a55b01930146… | |
| 2019-12-08 06:16 UTC · source 2019-12-05 | excluded package | package | 64725-2435-1 | 110d247fa046… | a55b01930146… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A040715-001 | BENZTROPINE MESYLATE | BENZTROPINE MESYLATE | 0.5MG | TABLET / ORAL | AA | 2007-08-27 | |
| A040715-002 | BENZTROPINE MESYLATE | BENZTROPINE MESYLATE | 1MG | TABLET / ORAL | AA | 2007-08-27 | |
| A040715-003 | BENZTROPINE MESYLATE | BENZTROPINE MESYLATE | 2MG | TABLET / ORAL | AA | 2007-08-27 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A040715-001 | AA |
| A040715-002 | AA |
| A040715-003 | AA |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A040715-001 | BENZTROPINE MESYLATE | 0.5MG | TABLET / ORAL | AA | 2007-08-27 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A040715-002 | BENZTROPINE MESYLATE | 1MG | TABLET / ORAL | AA | 2007-08-27 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A040715-003 | BENZTROPINE MESYLATE | 2MG | TABLET / ORAL | AA | 2007-08-27 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040715-001 | BENZTROPINE MESYLATE | 0.5MG | TABLET / ORAL | AA | 2007-08-27 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040715-002 | BENZTROPINE MESYLATE | 1MG | TABLET / ORAL | AA | 2007-08-27 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040715-003 | BENZTROPINE MESYLATE | 2MG | TABLET / ORAL | AA | 2007-08-27 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A040715-001 | BENZTROPINE MESYLATE | 0.5MG | TABLET / ORAL | AA | 2007-08-27 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A040715-002 | BENZTROPINE MESYLATE | 1MG | TABLET / ORAL | AA | 2007-08-27 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A040715-003 | BENZTROPINE MESYLATE | 2MG | TABLET / ORAL | AA | 2007-08-27 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040715-001 | BENZTROPINE MESYLATE | 0.5MG | TABLET / ORAL | AA | 2007-08-27 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040715-002 | BENZTROPINE MESYLATE | 1MG | TABLET / ORAL | AA | 2007-08-27 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040715-003 | BENZTROPINE MESYLATE | 2MG | TABLET / ORAL | AA | 2007-08-27 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040715-001 | BENZTROPINE MESYLATE | 0.5MG | TABLET / ORAL | AA | 2007-08-27 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040715-002 | BENZTROPINE MESYLATE | 1MG | TABLET / ORAL | AA | 2007-08-27 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040715-003 | BENZTROPINE MESYLATE | 2MG | TABLET / ORAL | AA | 2007-08-27 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040715-001 | BENZTROPINE MESYLATE | 0.5MG | TABLET / ORAL | AA | 2007-08-27 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040715-002 | BENZTROPINE MESYLATE | 1MG | TABLET / ORAL | AA | 2007-08-27 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040715-003 | BENZTROPINE MESYLATE | 2MG | TABLET / ORAL | AA | 2007-08-27 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040715-001 | BENZTROPINE MESYLATE | 0.5MG | TABLET / ORAL | AA | 2007-08-27 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040715-002 | BENZTROPINE MESYLATE | 1MG | TABLET / ORAL | AA | 2007-08-27 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040715-003 | BENZTROPINE MESYLATE | 2MG | TABLET / ORAL | AA | 2007-08-27 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040715-001 | BENZTROPINE MESYLATE | 0.5MG | TABLET / ORAL | AA | 2007-08-27 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040715-002 | BENZTROPINE MESYLATE | 1MG | TABLET / ORAL | AA | 2007-08-27 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040715-003 | BENZTROPINE MESYLATE | 2MG | TABLET / ORAL | AA | 2007-08-27 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A040715-001 | BENZTROPINE MESYLATE | 0.5MG | TABLET / ORAL | AA | 2007-08-27 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A040715-002 | BENZTROPINE MESYLATE | 1MG | TABLET / ORAL | AA | 2007-08-27 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A040715-003 | BENZTROPINE MESYLATE | 2MG | TABLET / ORAL | AA | 2007-08-27 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A040715-001 | BENZTROPINE MESYLATE | 0.5MG | TABLET / ORAL | AA | 2007-08-27 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A040715-002 | BENZTROPINE MESYLATE | 1MG | TABLET / ORAL | AA | 2007-08-27 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A040715-003 | BENZTROPINE MESYLATE | 2MG | TABLET / ORAL | AA | 2007-08-27 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A040715-001 | BENZTROPINE MESYLATE | 0.5MG | TABLET / ORAL | AA | 2007-08-27 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A040715-002 | BENZTROPINE MESYLATE | 1MG | TABLET / ORAL | AA | 2007-08-27 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A040715-003 | BENZTROPINE MESYLATE | 2MG | TABLET / ORAL | AA | 2007-08-27 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A040715-001 | BENZTROPINE MESYLATE | 0.5MG | TABLET / ORAL | AA | 2007-08-27 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A040715-002 | BENZTROPINE MESYLATE | 1MG | TABLET / ORAL | AA | 2007-08-27 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A040715-003 | BENZTROPINE MESYLATE | 2MG | TABLET / ORAL | AA | 2007-08-27 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A040715-001 | BENZTROPINE MESYLATE | 0.5MG | TABLET / ORAL | AA | 2007-08-27 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A040715-002 | BENZTROPINE MESYLATE | 1MG | TABLET / ORAL | AA | 2007-08-27 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A040715-003 | BENZTROPINE MESYLATE | 2MG | TABLET / ORAL | AA | 2007-08-27 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A040715-001 | BENZTROPINE MESYLATE | 0.5MG | TABLET / ORAL | AA | 2007-08-27 | 8072bd15b7f6… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A040715-001 | AA | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A040715-002 | AA | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A040715-003 | AA | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040715-001 | AA | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040715-002 | AA | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040715-003 | AA | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A040715-001 | AA | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A040715-002 | AA | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A040715-003 | AA | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040715-001 | AA | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040715-002 | AA | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040715-003 | AA | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040715-001 | AA | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040715-002 | AA | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040715-003 | AA | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040715-001 | AA | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040715-002 | AA | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040715-003 | AA | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040715-001 | AA | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040715-002 | AA | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040715-003 | AA | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040715-001 | AA | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040715-002 | AA | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040715-003 | AA | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A040715-001 | AA | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A040715-002 | AA | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A040715-003 | AA | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A040715-001 | AA | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A040715-002 | AA | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A040715-003 | AA | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A040715-001 | AA | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A040715-002 | AA | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A040715-003 | AA | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A040715-001 | AA | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A040715-002 | AA | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A040715-003 | AA | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A040715-001 | AA | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A040715-002 | AA | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A040715-003 | AA | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A040715-001 | AA | 1 | 8072bd15b7f6… |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 2961cf47-535c-c402-c24d-0a9130269674 | Product name | 3 | 20251121 |
| 3f930a8b-cc65-fba9-e4ca-58b6abcea16b | Product name | 2 | 20220509 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 64725-2435-1 | 2019-11-27 | C162847 | 48780-1 | 9855e2a2-46f8-60a7-e053-dbdaa90a05bd | BENZTROPINE MESYLATE TABLETS, USP 0.5 mg, 1 mg and 2 mg |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 64725-2435-1 | Benztropine Mesylate | 30 in 1 CONTAINER | TABLET | 30 | 4 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| BENZTROPINE MESYLATE | ACTIVE INGREDIENT | WMJ8TL7510 | BENZTROPINE MESYLATE TABLET [TYA PHARMACEUTICALS] | 4 | |
| BENZTROPINE | ACTIVE MOIETY | 1NHL2J4X8K | BENZTROPINE MESYLATE TABLET [TYA PHARMACEUTICALS] | 4 | |
| CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS | INACTIVE INGREDIENT | L11K75P92J | BENZTROPINE MESYLATE TABLET [TYA PHARMACEUTICALS] | 4 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | BENZTROPINE MESYLATE TABLET [TYA PHARMACEUTICALS] | 4 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | BENZTROPINE MESYLATE TABLET [TYA PHARMACEUTICALS] | 4 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | BENZTROPINE MESYLATE TABLET [TYA PHARMACEUTICALS] | 4 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | BENZTROPINE MESYLATE TABLET [TYA PHARMACEUTICALS] | 4 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 64725-2435 | BENZTROPINE MESYLATE TABLET [TYA PHARMACEUTICALS] | 4 | Legacy NDC, 1 package rows | 20140901_c06c51ff-65ba-42c1-9dd8-e8d4a212981b.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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Benztropine Mesylate | BENZTROPINE MESYLATE | Unit Dose Solutions, Inc. | 53c02a89-012c-e724-e063-6294a90acc75 | 2026-06-08 | Warnings, Adverse reactions | 040715 ANDA040715 |
| Benztropine Mesylate | BENZTROPINE MESYLATE | Coupler LLC | 52bd605a-6a28-c2ec-e063-6294a90a8371 | 2026-05-26 | Warnings, Adverse reactions | 040715 ANDA040715 |
| Benztropine Mesylate | BENZTROPINE MESYLATE | Coupler LLC | 512ada3e-4b85-d989-e063-6394a90a9d54 | 2026-05-06 | Warnings, Adverse reactions | 040715 ANDA040715 |
| Benztropine Mesylate | BENZTROPINE MESYLATE | Coupler LLC | 5035534e-e15c-8f06-e063-6294a90a5003 | 2026-04-24 | Warnings, Adverse reactions | 040715 ANDA040715 |
| Benztropine Mesylate | BENZTROPINE MESYLATE | NCS HealthCare of KY, LLC dba Vangard Labs | bac9dfb7-aa09-4841-9e8f-cc41bb438fe2 | 2026-04-15 | Warnings, Adverse reactions | 040715 ANDA040715 |
| BENZTROPINE MESYLATE | BENZTROPINE MESYLATE | DIRECT RX | 9b93035b-34d6-4084-ba73-5dea72f9d124 | 2026-03-17 | Warnings, Adverse reactions | 040715 ANDA040715 |
| Benztropine Mesylate | BENZTROPINE MESYLATE | NCS HealthCare of KY, LLC dba Vangard Labs | df0647b8-2aa7-4aa4-9ba3-82c28698e7c5 | 2026-01-23 | Warnings, Adverse reactions | 040715 ANDA040715 |
| Benztropine Mesylate | BENZTROPINE MESYLATE | American Health Packaging | b7f915a9-cd53-4a74-8ee5-35ee5c5c991e | 2025-11-18 | Warnings, Adverse reactions | 040715 ANDA040715 |
| Benztropine Mesylate | BENZTROPINE MESYLATE | Major Pharmaceuticals | 8b18b66c-2935-4304-8e20-ebf68dee5a1a | 2025-01-16 | Warnings, Adverse reactions | 040715 ANDA040715 |
| Benztropine Mesylate | BENZTROPINE MESYLATE | A-S Medication Solutions | 53b134eb-b341-4fe4-a3ca-90a7da011974 | 2024-01-07 | Warnings, Adverse reactions | 040715 ANDA040715 |
| Benztropine Mesylate | BENZTROPINE MESYLATE | Bryant Ranch Prepack | 959363b8-6847-4f6e-9957-6254febb085c | 2023-05-30 | Warnings, Adverse reactions | 040715 ANDA040715 |
| Benztropine Mesylate | BENZTROPINE MESYLATE | Endo USA, Inc. | c19664aa-a797-4192-b5f3-e906a7cac048 | 2022-03-16 | Warnings, Adverse reactions | 040715 ANDA040715 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 885213 | benztropine mesylate 1 MG Oral Tablet | PSN | c06c51ff-65ba-42c1-9dd8-e8d4a212981b | 4 |
| 885209 | benztropine mesylate 2 MG Oral Tablet | PSN | c06c51ff-65ba-42c1-9dd8-e8d4a212981b | 4 |
| 885213 | benztropine mesylate 1 MG Oral Tablet | SCD | c06c51ff-65ba-42c1-9dd8-e8d4a212981b | 4 |
| 885209 | benztropine mesylate 2 MG Oral Tablet | SCD | c06c51ff-65ba-42c1-9dd8-e8d4a212981b | 4 |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 64725-2435-1 | 64725243501 | 30 in 1 CONTAINER | Historical |