Benztropine Mesylate
- Product NDC
- 69097-832
- 11-digit product format
- 690970832
- Labeler code
- 69097
- Product ID
- 69097-832_3d362141-de53-4949-b9a5-34f2b7bb0e75
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Benztropine
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Cipla USA Inc.
- Application
- ANDA090294
- Marketing category
- ANDA
- Marketing start
- 2016-06-29
- 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 |
|---|
| 69097-832-02 | Benztropine Mesylate | 30 in 1 BOTTLE | TABLET | 30 | | 3 |
| 69097-832-07 | Benztropine Mesylate | 100 in 1 BOTTLE | TABLET | 100 | | 3 |
| 69097-832-15 | Benztropine Mesylate | 1000 in 1 BOTTLE | TABLET | 1000 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 69097-832 | BENZTROPINE MESYLATE (BENZTROPINE) TABLET [CIPLA USA INC.] | 3 | Current NDC, Legacy NDC, 3 package rows | 20200502_3d2732f9-b8a9-4e83-91e7-da616ddcb786.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 |
|---|
| 69097-832-02 | 69097083202 | 30 TABLET in 1 BOTTLE (69097-832-02) | 30 tablet | 2016-06-29 | 0000-00-00 | No | No | Current |
| 69097-832-07 | 69097083207 | 100 TABLET in 1 BOTTLE (69097-832-07) | 100 tablet | 2016-06-29 | 0000-00-00 | No | No | Current |
| 69097-832-15 | 69097083215 | 1000 TABLET in 1 BOTTLE (69097-832-15) | 1000 tablet | 2016-06-29 | 0000-00-00 | No | No | Current |