Benztropine Mesylate
- Product NDC
- 67046-0041
- 11-digit product format
- 670460041
- Labeler code
- 67046
- Product ID
- 67046-0041_50354b08-fe56-fdca-e063-6394a90a1cdb
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- benztropine mesylate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Coupler LLC
- Application
- ANDA040715
- Marketing category
- ANDA
- Marketing start
- 2026-04-24
- Substance
- BENZTROPINE MESYLATE
- Active strength
- 1 mg/1
- Pharmacologic classes
- Anticholinergic [EPC], Antihistamine [EPC], Cholinergic Antagonists [MoA], Histamine Receptor Antagonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A040715-001 | BENZTROPINE MESYLATE | 0.5MG | TABLET / ORAL | AA | 2007-08-27 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A040715-002 | BENZTROPINE MESYLATE | 1MG | TABLET / ORAL | AA | 2007-08-27 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A040715-003 | BENZTROPINE MESYLATE | 2MG | TABLET / ORAL | AA | 2007-08-27 | caaa826d4ba7… | |
| 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… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A040715-001 | AA | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A040715-002 | AA | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A040715-003 | AA | 1 | caaa826d4ba7… |
| 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… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Benztropine Mesylate
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| BENZTROPINE MESYLATE | 1 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| WMJ8TL7510 | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 885213 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 5035534e-e15c-8f06-e063-6294a90a5003 | Available on FDA.report |
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 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 67046-0041-3 | Benztropine Mesylate | 30 in 1 BLISTER PACK | TABLET | 30 | 1 |
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 67046-0041 |
| 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 | 5035534e-e15c-8f06-e063-6294a90a5003 | 1 |
| 885213 | benztropine mesylate 1 MG Oral Tablet | SCD | 5035534e-e15c-8f06-e063-6294a90a5003 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 67046-0041-3 | 67046004103 | 30 TABLET in 1 BLISTER PACK (67046-0041-3) | 30 tablet | 2026-04-24 | No | No | Current |