BENZTROPINE MESYLATE
- Product NDC
- 69315-138
- 11-digit product format
- 693150138
- Labeler code
- 69315
- Product ID
- 69315-138_f61e0118-7898-42cf-9e27-e5f2dabe6ea4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- BENZTROPINE MESYLATE
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Leading Pharma, LLC
- Application
- ANDA090168
- Marketing category
- ANDA
- Marketing start
- 2012-11-28
- 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
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- BENZTROPINE MESYLATE
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| BENZTROPINE MESYLATE | 2 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | WMJ8TL7510 |
| Rxcui | 885209, 885213, 885219 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 69315-138-01 | BENZTROPINE MESYLATE | 100 in 1 BOTTLE | TABLET | 100 | | 8 |
| 69315-138-10 | BENZTROPINE MESYLATE | 1000 in 1 BOTTLE | TABLET | 1000 | | 8 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 69315-138 | BENZTROPINE MESYLATE TABLET [LEADING PHARMA, LLC] | 8 | Current NDC, Legacy NDC, 2 package rows | 20211123_fe002ec4-07cb-41ca-a58c-33b3a8682101.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 69315-138-01 | 69315013801 | 100 TABLET in 1 BOTTLE (69315-138-01) | 100 tablet | 2016-05-15 | 0000-00-00 | No | No | Current |
| 69315-138-10 | 69315013810 | 1000 TABLET in 1 BOTTLE (69315-138-10) | 1000 tablet | 2016-05-15 | 0000-00-00 | No | No | Current |