Benztropine Mesylate
- Product NDC
- 0615-8478
- 11-digit product format
- 006158478
- Labeler code
- 0615
- Product ID
- 0615-8478_a3d10935-5a1b-4ad4-900a-958aa93e1be2
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- benztropine mesylate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- NCS HealthCare of KY, LLC dba Vangard Labs
- Application
- ANDA040715
- Marketing category
- ANDA
- Marketing start
- 2022-03-17
- 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
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Benztropine Mesylate
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| BENZTROPINE MESYLATE | 2 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | WMJ8TL7510 |
| Rxcui | 885209 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0615-8478-39 | Benztropine Mesylate | 30 in 1 BLISTER PACK | TABLET | 30 | | 10 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0615-8478 | BENZTROPINE MESYLATE TABLET [NCS HEALTHCARE OF KY, LLC DBA VANGARD LABS] | 1 | Current NDC, 1 package rows | 20230504_bac9dfb7-aa09-4841-9e8f-cc41bb438fe2.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 |
|---|
| 0615-8478-39 | 00615847839 | 30 TABLET in 1 BLISTER PACK (0615-8478-39) | 30 tablet | 2023-04-28 | No | No | Historical |