BENZTROPINE MESYLATE
- Product NDC
- 10135-814
- 11-digit product format
- 101350814
- Labeler code
- 10135
- Product ID
- 10135-814_31bbcbfa-dc75-99e2-e063-6394a90aa608
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- benztropine mesylate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Marlex PHARMACEUTICAL, INC
- Application
- ANDA204713
- Marketing category
- ANDA
- Marketing start
- 2025-03-01
- 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 | 885209, 885213, 885219 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 10135-814-01 | BENZTROPINE MESYLATE | 100 in 1 BOTTLE | TABLET | 100 | | 1 |
| 10135-814-10 | BENZTROPINE MESYLATE | 1000 in 1 BOTTLE | TABLET | 1000 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 10135-814 | BENZTROPINE MESYLATE TABLET [MARLEX PHARMACEUTICAL, INC] | 1 | Current NDC, 2 package rows | 20250406_31bbcbfa-dc74-99e2-e063-6394a90aa608.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 10135-814-01 | 10135081401 | 100 TABLET in 1 BOTTLE (10135-814-01) | 100 tablet | 2025-03-01 | No | No | Current |
| 10135-814-10 | 10135081410 | 1000 TABLET in 1 BOTTLE (10135-814-10) | 1000 tablet | 2025-03-01 | No | No | Current |