Benztropine Mesylate
- Product NDC
- 0615-8222
- 11-digit product format
- 006158222
- Labeler code
- 0615
- Product ID
- 0615-8222_c7b0eaab-bce7-4133-85e9-6ec282c63e7c
- 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
- .5 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 | .5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | WMJ8TL7510 |
| Rxcui | 885213, 885219 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0615-8222-39 | 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 |
|---|
| 0615-8222 | BENZTROPINE MESYLATE TABLET [NCS HEALTHCARE OF KY, LLC DBA VANGARD LABS] | 2 | Current NDC, 1 package rows | 20230615_df0647b8-2aa7-4aa4-9ba3-82c28698e7c5.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 |
|---|
| 0615-8222-39 | 00615822239 | 30 TABLET in 1 BLISTER PACK (0615-8222-39) | 30 tablet | 2023-06-06 | No | No | Historical |