Benztropine Mesylate
- Product NDC
- 68084-389
- 11-digit product format
- 680840389
- Labeler code
- 68084
- Product ID
- 68084-389_43e32855-d7c9-07e1-e063-6294a90af347
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Benztropine Mesylate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- American Health Packaging
- Application
- ANDA040715
- Marketing category
- ANDA
- Marketing start
- 2013-07-01
- 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 |
|---|
| 68084-389-01 | Benztropine Mesylate | 100 in 1 BOX, UNIT-DOSE | TABLET | 100 | | 13 |
| 68084-389-11 | Benztropine Mesylate | 1 in 1 BLISTER PACK | TABLET | 1 | | 13 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68084-389 | BENZTROPINE MESYLATE TABLET [AMERICAN HEALTH PACKAGING] | 12 | Current NDC, Legacy NDC, 2 package rows | 20241215_b7f915a9-cd53-4a74-8ee5-35ee5c5c991e.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 |
|---|
| 68084-389-01 | 68084038901 | 100 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-389-01) / 1 TABLET in 1 BLISTER PACK (68084-389-11) | 100 blister pack | 2013-07-01 | 0000-00-00 | No | No | Current |
| 68084-389-11 | 68084038911 | 1 in 1 BLISTER PACK | | | | | | Historical |