BENZTROPINE MESYLATE
- Product NDC
- 71610-502
- 11-digit product format
- 716100502
- Labeler code
- 71610
- Product ID
- 71610-502_83880a96-336b-4e03-ac29-a41e62d78f3c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- BENZTROPINE MESYLATE
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Aphena Pharma Solutions - Tennessee, LLC
- Application
- ANDA090168
- Marketing category
- ANDA
- Marketing start
- 2012-11-28
- 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
- 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 | 1 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | WMJ8TL7510 |
| Rxcui | 885213 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 71610-502-53 | BENZTROPINE MESYLATE | 60 in 1 BOTTLE | TABLET | 60 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71610-502 | BENZTROPINE MESYLATE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | Current NDC, Legacy NDC, 1 package rows | 20210124_f82c6455-f36b-49d7-881e-6601d513d846.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 |
|---|
| 71610-502-53 | 71610050253 | 60 TABLET in 1 BOTTLE (71610-502-53) | 60 tablet | 2020-12-08 | 0000-00-00 | No | No | Current |