benztropine mesylate
- Product NDC
- 10858-011
- 11-digit product format
- 108580011
- Labeler code
- 10858
- Product ID
- 10858-011_67ef7746-45bc-466b-a7b7-353c8b8702c1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- benztropine mesylate
- Dosage form
- INJECTION
- Route
- INTRAMUSCULAR; INTRAVENOUS
- Labeler
- Wintac Limited
- Application
- ANDA091525
- Marketing category
- ANDA
- Marketing start
- 2020-11-26
- Marketing end
- 0000-00-00
- Substance
- BENZTROPINE MESYLATE
- Active strength
- 1 mg/mL
- Pharmacologic classes
- Anticholinergic [EPC],Antihistamine [EPC],Cholinergic Antagonists [MoA],Histamine Receptor Antagonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2021-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 10858-011-01 | benztropine mesylate | 2 mL in 1 VIAL | INJECTION | 2 | | 1 |
| 10858-011-05 | benztropine mesylate | 5 in 1 CARTON | INJECTION | 5 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 10858-011 | BENZTROPINE MESYLATE INJECTION [WINTAC LIMITED] | 1 | Legacy NDC, 2 package rows | 20201127_357140ce-d84f-43e2-a106-bb2175f46417.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 |
|---|
| 10858-011-01 | 10858001101 | 2 mL in 1 VIAL | 2 ml | | | | | Historical |
| 10858-011-05 | 10858001105 | 5 VIAL in 1 CARTON (10858-011-05) > 2 mL in 1 VIAL (10858-011-01) | 5 vial | 2020-11-26 | 0000-00-00 | No | No | Current |