Benztropine Mesylate
- Product NDC
- 0832-1082
- 11-digit product format
- 008321082
- Labeler code
- 0832
- Product ID
- 0832-1082_2711e70f-cc34-4092-b4fc-47e426cef420
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- benztropine mesylate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Upsher-Smith Laboratories, LLC
- Application
- ANDA040103
- Marketing category
- ANDA
- Marketing start
- 1996-12-12
- 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
- No
- Listing certified through
- 2020-12-31
- Current FDA listing
- Historical FDA.report record
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 Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0832-1082-00 | EA - Each | 0832-1082 | 0ccc8d53-d417-4f38-9e5c-4497f4607f6d | 1 | 2012-07-24 |
| 0832-1082-10 | EA - Each | 0832-1082 | 98caf87a-0889-4918-8449-7950a6855e53 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| BENZTROPINE MESYLATE | ACTIVE INGREDIENT | WMJ8TL7510 | BENZTROPINE MESYLATE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| benztropine mesylate | ACTIVE INGREDIENT | WMJ8TL7510 | BENZTROPINE MESYLATE TABLET [CONTRACT PHARMACY SERVICES-PA] | 1 | |
| BENZTROPINE | ACTIVE MOIETY | 1NHL2J4X8K | BENZTROPINE MESYLATE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| benztropine | ACTIVE MOIETY | 1NHL2J4X8K | BENZTROPINE MESYLATE TABLET [CONTRACT PHARMACY SERVICES-PA] | 1 | |
| ANHYDROUS LACTOSE | INACTIVE INGREDIENT | 3SY5LH9PMK | BENZTROPINE MESYLATE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | BENZTROPINE MESYLATE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | BENZTROPINE MESYLATE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| POVIDONE | INACTIVE INGREDIENT | FZ989GH94E | BENZTROPINE MESYLATE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 885213 | benztropine mesylate 1 MG Oral Tablet | PSN | 8ab4fb43-045f-4104-bd62-55f8d3bae95a | 1 |
| 885209 | benztropine mesylate 2 MG Oral Tablet | PSN | 4e4e7035-e98f-4516-be82-8bca14b1f78c | 1 |
| 885209 | benztropine mesylate 2 MG Oral Tablet | PSN | 8ab4fb43-045f-4104-bd62-55f8d3bae95a | 1 |
| 885213 | benztropine mesylate 1 MG Oral Tablet | SCD | 8ab4fb43-045f-4104-bd62-55f8d3bae95a | 1 |
| 885209 | benztropine mesylate 2 MG Oral Tablet | SCD | 4e4e7035-e98f-4516-be82-8bca14b1f78c | 1 |
| 885209 | benztropine mesylate 2 MG Oral Tablet | SCD | 8ab4fb43-045f-4104-bd62-55f8d3bae95a | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0832-1082-00 | 00832108200 | 100 TABLET in 1 BOTTLE (0832-1082-00) | 100 tablet | 1996-12-12 | 0000-00-00 | No | No | Current |
| 0832-1082-10 | 00832108210 | 1000 TABLET in 1 BOTTLE (0832-1082-10) | 1000 tablet | 1996-12-12 | 0000-00-00 | No | No | Current |